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NEWS IN IMPLANTOLOGY

28 September 2016
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February 16, 2024The German Society for Endoprosthetics (AE) is concerned about potential shortages of artificial hip and knee joints. Bureaucratic hurdles urgently need to be removed, as otherwise the EU Medical Device Regulation (MDR) would increasingly jeopardize patient safety, it said today. The MDR, which came into force in 2021, has been criticized since its inception and the warnings issued at the time seem to be increasingly coming true: Specialized medical devices in particular, which are manufactured in small quantities, are increasingly disappearing from the supply chain. In addition to reducing bureaucratic hurdles, the association is therefore also calling for a simplified approval and recertification process in order to safeguard care and continue to enable innovation. Only this would make it possible to bring implants for special requirements onto the market quickly and unbureaucratically and ensure modern and patient-oriented medical care. Author(s) Source lau/aerzteblatt.de aerzteblatt.de 16.02.2024 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
January 12, 2024In the scandal surrounding defective breast implants from French manufacturer Poly Implant Prothèse (PIP), a court has ordered TÜV Rheinland to pay more than ten million euros. The testing company must compensate 605 of 1,319 plaintiffs. Most of the women in these proceedings come from Great Britain. The court stated that from 2002 onwards, there had been a discrepancy at PIP between the quantity of gel ordered for the breast implants and the number of prostheses produced. This should have been noticed. The TÜV’s lawyer criticized the ruling and recommended an appeal. From 2001 to 2010, PIP sold around one million of the poor-quality implants worldwide. 400,000 women suffered damage to their health. In Germany, Belgium, Italy and Spain, complaints have been dismissed, emphasized TÜV Rheinland. Only in France are there still legal disputes. According to its own information, TÜV Rheinland did not test the implants of the manufacturing company PIP, but certified the company’s quality management system. In 2016, PIP founder Jean-Claude Mas was sentenced to four years in prison and a fine of 75,000 euros for serious fraud and deceiving TÜV. He died in 2019. Author(s) Source afp/aerzteblatt aerzteblatt 12.01.2024 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 29, 2023The US Food and Drug Administration (FDA) has approved an intraocular implant for the treatment of open-angle glaucoma or ocular hypertension. The capsule placed in the angle of the chamber continuously releases the prostaglandin analog travoprost, which improves the outflow of aqueous humor. The implantation of “iDose” frees patients from the daily use of eye drops. It is implanted in the iridocorneal angle between the cornea and the iris. There it penetrates the sclera with its tip, where it is firmly anchored with a barb. The most common ocular side effects, which occurred in 2 % to 6 % of iDose TR patients, were increases in intraocular pressure, iritis, dry eyes and visual field defects, which were mostly mild and improved on their own. Author(s) Source FDA, Reference ID: 5292678 NDA 218010 Page 4 – accessdata.fda.gov This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 21, 2023The patient, had a history of vaping and multiple infections, first viral infections and then Pseudomonas pneumonia. He had a really severe infection in both lungs. He was ventilated but the ventilator was not sufficient to keep him alive. He was then placed on the extracorporeal membrane oxygenation (ECMO), and he was dying on the ECMO, with no other options for him at that time. He was failing antibiotic treatments, and unfortunately, ECMO was not bridged for his survival or improvement. The hope, of course, is that bypassing the heart-lung system allows the lungs times time to heal and eventually you can wean the patient off ECMO, back to the ventilator, and then off the ventilator. But this was not the case here. In his current condition, he was not a candidate for a lung transplant. We came to idea to actually remove the lungs from the patient. The patient would be living without his lungs while we waited for new lungs to be available from a donor. We had to create artificial channels in the heart, reconnecting the right and left side of the body and implanting oxygenators to take over the function of the lungs. The heart was beating in a chest cavity in the absence of lungs stabilizing it from either side. To keep the heart stable two breast implants were put on either side of it. When the transplant lungs arrived, the breast implants were removed and the lungs were put in. Now the patient is out of the hospital, out of rehab, and here, at his temporary home in Chicago and doing really well. Author(s) Source Wilson FP Medscape Dec 21, 2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 19, 2023“After the procedure, Jonah was a different child, the improvement was immediate. He turned 180 degrees in the right direction,” says his mother Ania. On June 22 of this year, the boy underwent an effective procedure in the cardiac catheterization laboratory at the Heart and Diabetes Center NRW (HDZ NRW) in Bad Oeynhausen when he was just six months old. Prof. Stephan Schubert, Director of Pediatric Cardiology there, closed Jonah’s open ductus arteriosus with a small nitinol umbrella, a “piccolo” umbrella. The ductus arteriosus is a small vessel that connects the aorta with the pulmonary artery in the unborn baby. In the womb, blood is pumped from the right ventricle into the aorta via the ductus, bypassing the lungs. After birth, when the lungs develop and the newborn begins to breathe, the duct closes spontaneously within hours to days after birth. If it fails to do so, it is referred to as a persistent ductus arteriosus botalli (PDA). Jonah and his twin brother were also affected by an open ductus when they were born prematurely in December 2022. The [...] Read more...
December 4, 2023a phase 1, randomized feasibility study Converging evidence indicates that impairments in executive function and information-processing speed limit quality of life and social reentry after moderate-to-severe traumatic brain injury (msTBI). These deficits reflect dysfunction of frontostriatal networks for which the central lateral (CL) nucleus of the thalamus is a critical node. The primary objective of this feasibility study was to test the safety and efficacy of deep brain stimulation within the CL and the associated medial dorsal tegmental (CL/DTTm) tract. CL/DTTm deep brain stimulation can be safely applied and may improve executive control in patients with msTBI who are in the chronic phase of recovery. Author(s) Source Schiff ND, Giacino JT, Butson CR et al. Nat Med (2023). https://doi.org/10.1038/s41591-023-02638-4 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
September 27, 2023Traditional prostheses after limb amputations allow only a part of the affected persons to achieve the desired and desired autonomous mobility. In analogy to dental implants, systems have been developed that allow the coupling of an exoprosthesis to a force carrier integrated in the bone and transmitted through the skin. Almost all of the problems associated with prosthetic limb replacement are due less to the functionality of the artificial joints and more to the prosthesis fixation systems that surround the residual limb. Therefore, starting in the 1990s, a concept analogous to dental implants was developed for limb replacement: A load bearing device permanently fixed in the bone and transmitted transcutaneously serves to couple the prosthesis.Such transcutaneous osseointegrated prosthesis systems (TOPS) represent a paradigm shift in care after limb amputation. They have become an indispensable part of the rehabilitation options, both in view of the high mobility gain and the significantly improved patient satisfaction. After initially proceeding in two stages and applying the stoma 4-6 weeks after insertion of the force carrier, the one-stage procedure has now proven successful. Depending on the bone quality of the soft tissue situation and the patient’s sensation, docking of the exoprosthesis by the orthopedic technician and subsequent mobilization can begin 3-6 weeks later. The interface between the endomodule and the exomodule is located between the conical sleeve and the knee connection adapter, which is firmly attached to the exoprosthesis and can be fixed or loosened by the patient with one hand. The knee joints are regularly equipped with microprocessors for control, as this minimizes the risk of falls. Between January 2003 and December 2021, the authors treated 244 patients (151 m/71 w) with a median age of 47.6 years (17-95 years), some bilaterally; long-term outcome data are available from 232 patients. To date, 13 femoral implants have been removed due to intramedullary infection, implant fatigue failure (after 7-14 years), chronic soft tissue problems, and patient request. TOPS reimplantation was successful in 4 of these patients. Author(s) Source Aschoff HH, Saß M, Mittlmeier Th, Fischer D-C Dtsch Arztebl 2023; 120(38): A-1518 / B-1304 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
September 24, 2023A team of scientists led by a Japanese pharmaceutical startup has been working on a drug to stimulate the growth of new teeth in what would be a world-first, aiming to put it on the market by around 2030. Does it make dental implants obsolete? The team plans to hold a clinical trial for the drug from 2025 for children between 2 and 6 years old with anodontia, who are born without some or all permanent teeth. The children will be injected with one dose to induce teeth growth. There are also hopes to utilize the drug in the future for adults who have lost teeth due to cavities. “Missing teeth in a child can affect the development of their jaw bone,” said Katsu Takahashi, co-founder of Toregem Biopharma and head of dentistry and oral surgery at Kitano Hospital in Osaka. “We hope the drug will serve as a key to solving those problems,” he said. Author(s) Source Kyodo the Japan Times Sep 24, 2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
September 22, 2023A 58-year-old patient with terminal heart disease became the second patient in the world to receive a successful transplant of a genetically-modified pig heart on September 20. He is recovering well and communicating with his loved ones. This new patient had end-stage heart disease. He was deemed ineligible for a traditional transplant with a human heart, by UMMC and several other leading transplant hospitals, due to his pre-existing peripheral vascular disease and complications with internal bleeding. This transplant was the only option available for this patient who was facing near-certain death from heart failure. Author(s) Source Deborah Kotz University of Maryland, Medical Center, Press release 22.09.2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
September 21, 2023Our society is aging. So the number of people who need an artificial hip joint, for example, is also rising. This can have long-term consequences for the healthcare system. “In more than ten percent of cases, loosening of the implanted prosthesis occurs within 15 years after hip surgery” (Alexander Franck, MD). The time of detection plays a decisive role in planning a new operation that may be necessary: the earlier loosening is detected, the lower the complications in the event of a prosthesis replacement. “The presence of mechanical loosening or loosening due to infection significantly influences treatment and prognosis.” Using measurement data, Jan Lützelberger’s team hopes to be able to make a statement about early loosening in the future using an ultrasound-based measurement method. In addition, the method offers, in principle, the possibility of detecting the formation of a bacterial film on the prosthesis. Author(s) Source Cindy Dötschel Coburg University, Press releas 21.09.2023 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
September 11, 2023The treatment of bone tumors or severe bone injuries often poses major problems for medicine. Titanium, for example, is used as a bone replacement material. There is a risk that the rigid implant will loosen, leading to long-term problems. A second therapeutic approach, he said, is to remove bone material from the pelvis, for example, and transplant it to the damaged area. However, this is then additionally associated with another defect. (Hermann Seitz, University of Rostock). It has been known for some time that barium titanate, a piezoelectric ceramic, can be used to generate voltage potentials under mechanical pressure. The barium titanate is combined with so-called bioactive glasses. This material is known to release ions when it comes into contact with body fluids, thus developing its bioactivity. This material is mixed with barium titanate and then put into the 3D printer. “We want to have an implant that responds piezoelectrically to mechanical stimuli and is bioactive at the same time.” The goal, he says, is to have bone cells migrate into the porous implant from the adjacent tissue. Once colonization and vascularization have occurred, the implant remains in the body. The implant can be made to fit precisely after digital reconstruction in a 3D printer. It will be many years before this technology clears the hurdle into everyday clinical use. Author(s) Source Nadine Rudolph Press release Rostock University, 11.09.2023 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
September 8, 2023A research group at the Department of Cardiothoracic, Transplantation and Vascular Surgery at the Hannover Medical School (MHH, Germany) is working on developing vascular prostheses based on the body’s own fibrin. Unlike conventional plastic models, the biologically active aortic prostheses are recognized by the immune system as the body’s own and are included in the body’s defense against infection. This should prevent the formation of biofilms. But the fibrin prostheses also have a major disadvantage: they cannot withstand the high pressure loads that prevail in the aortic bloodstream. This can be improved by spider silk. This is extremely thin and tear-resistant and completely degradable in the human body. Author(s) Source press release MHH hil/Dtsch Ärztebl 08.09.2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
August 15, 2023Endoprosthetic surgeries often involve significant blood loss and result in up to 46 percent of patients requiring a blood transfusion during or after surgery. After various changes to procedures during and after surgery, surgical teams can now not only avoid the sometimes high blood loss associated with inserting a knee or hip prosthesis and subsequent problems such as infections, but also mobilize patients more quickly. Drains, i.e. the drainage of fluid from the tissue via a catheter, can also be dispensed with. Since the vessels are closed off, this tube is no longer needed. This also changes the routines on the ward: Drainage checks and changes are no longer necessary, but patients receive special cooling during aftercare and are mobilized more quickly. Author(s) Source hil/arzteblatt.de aerzteblatt 15.08.2023 (german) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
August 14, 2023Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In this open-label, non-randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with renewed physical rehabilitation to promote functional reorganization of ipsilesional cortex in 12 individuals with persistent (1–3 years), moderate-to-severe upper-extremity impairment. No serious perioperative or stimulation-related adverse events were encountered, with participants demonstrating a seven-point median improvement on the Upper-Extremity Fugl-Meyer Assessment. All individuals who enrolled with partial preservation of distal motor function exceeded minimal clinically important difference regardless of time since stroke, with a median improvement of 15 Upper-Extremity Fugl-Meyer Assessment points. These robust functional gains were directly correlated with cortical reorganization evidenced by increased ipsilesional metabolism. Our findings support the safety and feasibility of deep brain stimulation to the cerebellar dentate nucleus as a promising tool for modulation of late-stage neuroplasticity for functional recovery and the need for larger clinical trials. Author(s) Source Baker KB, Plow EB, Nagel S et al. nature medicine, 14 Aug 2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
August 10, 2023WHAT WE KNOWThey are biocompatible and osseoconductive and can reduce plaque on the implant surface. The Journal of International Society of Preventive & Community Dentistry concluded that current research on zirconia indicates its biocompatibility with surrounding tissues. Zirconia also showed osseoconductive properties and demonstrated positive interaction with soft tissue. Notably, the literature states the material reduced plaque formation on the implant surface, promoting better healing and successful implant treatment. Moreover, recent studies reflect that zirconia osseointegrates as well as or, in some cases, better than titanium, which is partly due to the high level of contact between the implant material and the jawbone. They have physical properties that make them attractive for implant dentistry. Zirconia’s physical properties exhibit good flexural strength, resistance to fracture, a low modulus of elasticity, and low thermal conductivity, which make it desirable for implants. They are an excellent material option for some patient segments. The material is chemically inactive. Persons with metal allergies or sensitivities, or those who want metal-free dentistry in general, may choose a zirconia implant. Additionally, because they are not dark like their titanium counterparts, zirconia implants do not result in dark lines around the gingival margin, which is particularly problematic in patients who receive titanium implants and have thin gingival tissue. WHAT WE DON´T KNOW Can zirconia implants last as long as titanium? Zirconia is a relatively new material for implants, so there is a smaller amount of data about long-term success. By contrast, titanium dental implants have been studied for decades, leading to excellent data about their long-term use.3 However, research is ramping up on the longevity of zirconia implants. A 2020 study suggests clinicians are placing more zirconia implants because there is an increase documented in about 180% of the studies published from 2015 to 2020, and those studies reveal a survival rate of 87% to 100% at 7.8 years.4 By contrast, titanium implants have a 96.4% survival rate after 10 years.5 Time (and more clinical studies) will tell whether the same is true for zirconia implants. Do 1-piece zirconia implants perform better than 2-piece? Still, clinicians should only recommend 2-piece zirconia implants after informing the patient of a lack of long-term success data. However, 1-piece abutments have limitations, primarily the reduction of angulation options, which can interfere with osseointegration and stability and the mechanical properties of the materials. The lack of studies on 2-piece implants does little to answer the question as to whether they might perform better. A 2022 Clinical Oral Implants Research study suggests that a 2-piece zirconia implant had high survival rates for single teeth in posterior jaws. Could mechanical properties degrade as zirconia implants age? Low-temperature degradation (LTD) is a problem for ceramics. LTD occurs in the presence of moisture, hydrogen, and water on stabilized ceramics, resulting in loss of strength and the ceramic’s other beneficial advantages.9 Zirconia is affected by LTD, and more research is needed to understand LTD’s effect on strength, density, and toughness as well as the long-term survival rates of zirconia implants. Would a combination of titanium and zirconia be a better material choice than one or the other? A 2022 systematic review in Dentistry Journal suggests that although titanium, zirconia, and titanium-zirconia implants all had a similar performance for tissue response and behavior, the combination of titanium and zirconia did better than either the titanium or zirconia implants for survival rates, marginal bone loss, and bleeding on probing. Will patients prefer them? Clinical investigations are needed to determine patient satisfaction with zirconia implants. Author(s) Source Lively T Dental Products Report, August 10, 2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
August 1, 2023Human cells that have been engineered to respond to an electrical current could be incorporated into future medical devices. Genetically engineered human cells that produce insulin when stimulated by a small electric current could one day be used to develop better treatments for type 1 diabetes. Author(s) Source Tozer L nature, news 01.08.2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
July 28, 2023Much has been developed in the field of prostheses and exoskeletons in recent years. However, the possibilities for a truly intuitive and, above all, non-invasive control systems are still lacking. The sensors currently in use are not sensitive enough for this. A consortium from research and industry wants to change that with the NeuroQ project. Last year, researchers at Fraunhofer IAF made a real breakthrough. For the first time, they were able to measure a magnetic field via stimulated emission. “So we have been able to show a magnetic field-dependent cavity signal, and for the first time.” The project leader, Jeske, is pleased to report. “Otherwise, we have only measured the magnetic field via fluorescence.” Compared to the fluorescence measurement, the laser signal was not only significantly stronger, but also much richer in contrast. Now the consortium must transfer this laser system, including the measurement methodology, into a sensor system and then integrate it into an industrially usable module Author(s) Source Anne Hofmann, Interview with Dr Jan Jeske, Deputy Business Unit Manager Quantum Devices, Fraunhofer Institute for Applied Solid State Physics IAF compamed tradefair, Düssseldorf 13-16 Nov 2023 exhibition This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
July 28, 2023Biomaterials required for 3D printing living cells are currently produced on an animal basis. A research project intends to develop materials based on human placental tissue for various 3D bioprinting technologies. 3D bioprinting aims to produce tissue structures for numerous applications such as non-animal testing, drug screening and regenerative medicine. The bio-materials used must be tailored to the needs of cells and keep them alive during and after the printing process. Author(s) Source HU3DINKS Consortium, Belgium and Austria Press release Up Nano, 28.07.2023 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
July 24, 2023Obesity prevalence has almost tripled worldwide since 1975 (Germany). Obesity is a risk factor for osteoarthritis of the hip and even more so of the knee. Compared to non-obese individuals, they have a higher risk of complications. The objective of this study was to analyze the association between obesity and complication rates, revision rates, and mortality after primary and revision hip and knee replacements. In our study, obesity was associated with an increased risk of revision surgery within one year. For hip arthroplasty, the risk of revision also increased with each BMI category. Recent studies have shown that obesity is associated with an increased rate of aseptic loosening resulting in prosthesis replacement. As well, an increased rate of infection has been reported in obese patients with subsequent removal or replacement of the prosthesis. Revision procedures for dislocation increased for hip implants with increasing BMI, whereas revisions decreased with increasing BMI. Obese patients continued to have higher rates of in-hospital adverse events in all groups, which was particularly evident in those with a BMI ≥ 40 kg/m². In-hospital mortality within 90 days was increased only in those with grade 3 obesity at primary procedures. Author(s) Source Jeschke E, Gehrke T, Günster C, et al. Dtsch Arztebl Int 2023; 120: 501-2; DOI: 10.3238/arztebl.m2023.0067 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
July 18, 2023A common European health data network is planned in the EU (European Health Data Space – EHDS). Problems are seen in the fact that the relationship of confidence and the doctor’s duty of secrecy must be maintained. The sovereignty of the data should remain with the patient. The EHDS is intended to manage secondary use of health data in addition to primary use. In this context, researchers, regulatory authorities, political decision-makers as well as industry (innovators, branch) are to be granted access to pseudonymized and anonymized data of EU citizens via a data access point for specific purposes. A board is to be established for monitoring purposes. Criticism is that the principles of data protection law, the principle of data minimization, data accuracy, storage limitation, integrity and confidentiality, and the principle of necessity are not sufficiently respected. Author(s) Source anonymous Hartmannbund Magazin 02/2023, 32-33 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
July 12, 2023According to the OECD, there are 204 hip replacements per 100,000 people in the USA, 315 in Germany, 128 in Spain and 68 in Israel. How long do patients in Germany and the United States stay in the hospital and rehab after hip replacement surgery? In Germany, about 10 nights in the hospital and twenty days in rehab are common. In America, patients are often out the day of surgery. They complete the rehabilitation afterwards at home under the guidance of skilled nursing staff. Patients in Germany were three times as frequent as those in the U.S. to require follow-up treatment within one month. Germans were almost twice as likely as Americans to need revision surgery within a year. Among those insured at Kaiser, those who were happiest with their new hip were those who had been in the hospital for a very short time. Was it due to pre-existing conditions? No. In terms of general health, the American patient cohort scored worse than the German cohort. Benedikt Simon, who knows both systems, blames the health care system for the big difference in the length of hospital stays. In Germany, hospitals bill insurers based on the number of cases. What happens before patients are admitted and after they are discharged doesn’t matter much. To prevent premature discharges, a minimum length of stay in the hospital is prescribed for hip joint operations. Otherwise, there are deductions. Kaiser insured patients pay a flat rate for their care, which the hospital then has to manage with. Author(s) Source Baltzer S Frankfurter Allgemeine Zeitung, 12.07.2023 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
June 24, 2023Bilateral simultaneous hip arthroplasty shows comparable early outcome and complication rate as staged bilateral hip arthroplasty for patients scored ASA 1-3 if performed by a high-volume surgeon No significant differences were found concerning the complication rate or early inpatient rehabilitation.Conclusion: Simultaneous bilateral hip arthroplasty in patients with symptomatic bilateral hip osteoarthritis is as safe and successful as a staged procedure if performed by a high-volume surgeon. Author(s) Source Kirschbaum S, Hube R, Perka C et al. Int Orthop. 2023 Oct;47(10):2571-2578. doi: 10.1007/s00264-023-05871-1. Epub 2023 Jun 24. see also: Arch Orthop Trauma Surg 2023 Oct 9.  doi: 10.1007/s00402-023-05078-4. This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
June 22, 2023Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. Author(s) Source Knops RE, Reddy VY, Ip JE et al. N Engl J Med 2023; 388:2360-2370 DOI: 10.1056/NEJMoa2300080 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
May 22, 2023Chronic pain syndromes are often refractory to treatment and cause substantial suffering and disability. Pain severity is often measured through subjective report, while objective biomarkers that may guide diagnosis and treatment are lacking. Four individuals with refractory neuropathic pain were implanted with chronic intracranial electrodes in the anterior cingulate cortex and orbitofrontal cortex (OFC). We successfully predicted intraindividual chronic pain severity scores from neural activity with high sensitivity using machine learning methods. Author(s) Source Shirvalkar P, Prosky J, Chin G et al. nature neuroscience 22.05.2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
May 17, 2023The Implant Registry Germany has received the first data on breast implants from hospitals. This marks the start of trial operation, the Federal Ministry of Health (BMG) announced today. Technically, the register has been operational since March 31 of this year. The registry will deal with breast implants, as well as hip and knee endoprostheses. For breast implants, mandatory reporting is planned for January 1, 2024. Author(s) Source may/EB/aerzteblatt.de aerzteblatt.de 17.05.2023 (german text) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
April 17, 2023Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new ‘high-power’ charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. Conclusions The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results. Author(s) Source Lennerz C, Schaarschmidt C, Blazek P et al. EP Europace, euad042, https://doi.org/10.1093/europace/euad042 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
March 28, 2023Treatment with Zygoma implants is a treatment option for edentulous patients in the maxilla to obtain a fixed prosthesis with implants within one day and even with very little jaw bone. Case report with pictures. Author(s) Source Kraus D Dentale Implantologie & Parodontologie 28.03.2023 (german) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
March 1, 2023Berlin – Health researchers are expecting progress from the EU Commission’s initiative for cross-border use of medical data. Health researcher Ferdinand Gerlach of the University of Frankfurt am Main highlighted the practical benefits of a European Health Data Space. It is a matter of life and health if physicians throughout Europe have access to medical data, including that of foreign patients, he said. The effective transfer of this information is important, for example, in the case of identified drug risks. Patients with rare diseases in particular benefit from the European Health Data Area, Gerlach added. This is because there are often not enough cases for research. The benefits of an EHDS are large and concrete, he said. Christof von Kalle of the Berlin Institute for Health Research at the Charité said it is about data spaces over which patients have power of disposal, but which must also be complete. In addition, the software products used must be designed to be interoperable. Manufacturers should be obliged to offer such transition points at no additional cost. Cryptography expert Dominique Schröder of the University of Erlangen-Nuremberg asserted that the processing of large amounts of data does not conflict with privacy and data protection. In the EU project, IT security should be involved from the beginning. Data protection law expert Fruzsina Molnar-Gabor of the Heidelberg Academy of Sciences also advocated the broad availability of health-related data. However, high data protection requirements would also have to be met. The EU is currently a long way from digital networking and interoperability, the data systems are too different and not linked nationally, she said. Marcel Weigand of the Independent Patient Counseling Service (UPD) spoke of a significant initiative in favor of patient care, according to the Bundestag. Already today, cross-border health services are available in several EU countries. Germany, on the other hand, is lagging behind and needs to catch up. Larger data volumes would also bring advantages in healthcare research. What is needed, however, are security, reliability and transparency. Author(s) Source © EB/aerzteblatt.de aerzteblatt.de 01.03.2023 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 28, 2023Fifty years after the term brain–computer interface was coined, the neurotechnology is being pursued by an array of start-up companies using a variety of different technologies. But the path to clinical and commercial success remains uncertain. Of the companies developing BCIs (brain-computer interface) with implanted recording systems, two are exclusively pursuing ECoG (electrocorticography) devices. The year 2023 promises to be significant for BCIs. Multiple non-invasive systems are likely to enter the hands of researchers and clinicians, and several key clinical trials of implanted systems are scheduled to begin. To succeed, BCIs must establish themselves as safe and truly helpful to people with serious medical conditions. Author(s) Source Drew L Nature Electronics volume 6, pages90–95 (2023) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 24, 2023Bioelectrodes have been developed to efficiently mediate electrical signals of biological systems as stimulators and recording devices. Recently, conductive hydrogels have garnered great attention as emerging materials for bioelectrode applications because they can permit intimate/conformal contact with living tissues and tissue-like softness. However, administration and control over the in vivo lifetime of bioelectrodes remain challenges. Here, injectable conductive hydrogels (ICHs) with tunable degradability as implantable bioelectrodes are developed. The hydrolyzable conductive hydrogels disappeared 3 days after in vivo administration, while the stable conductive hydrogels maintained their shapes for up to 7 days. Author(s) Source Park J, Lee S, Lee M, Kim H-S, Lee JY Wiley Online Library, nano micro small, 24.02.2023, https://doi.org/10.1002/smll.202300250 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 20, 2023Cerebral strokes can disrupt descending commands from motor cortical areas to the spinal cord, which can result in permanent motor deficits of the arm and hand. However, below the lesion, the spinal circuits that control movement remain intact and could be targeted by neurotechnologies to restore movement. Here we report results from two participants in a first-in-human study using electrical stimulation of cervical spinal circuits to facilitate arm and hand motor control in chronic post-stroke hemiparesis. We found that continuous stimulation through selected contacts improved strength, kinematics and functional movements, thereby enabling participants to perform movements that they could not perform without spinal cord stimulation. While we cannot conclusively evaluate safety and efficacy from two participants, our data provide promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke. Author(s) Source Powell MP, Verma N, Sorensen E et al. Nat Med (2023). https://doi.org/10.1038/s41591-022-02202-6 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 17, 2023Hearing is a basic skill needed to participate in daily life. Hearing loss therefore often significantly limits the quality of life. Nevertheless, there are hardly any epidemiological data on the prevalence of hearing disorders in Germany. The study examined the prevalence of hearing impairment and the actual provision of hearing aids. In total, tonaudiometric data from 5 024 participants could be analyzed. The prevalence of hearing loss in at least one ear, regardless of severity, was 40.6% in the study population. Low-grade hearing loss was found in 22.5% of the participants, moderate hearing loss in 8.3%, and profound hearing loss in 2.8% (classification according to Röser from 1973). The hearing ability of women was better than that of men (on average by 4.3 dB). An increased prevalence of hearing impairment was seen with increasing age. Only 7.7% of participants had bilateral hearing aids. The discrepancy between the prevalence of hearing loss and the indication for hearing aid fitting results from the different ways in which hearing loss is determined and the indication is made. Conclusion: The prevalence of hearing loss was high at 40.6%. For the general population in Germany, regular hearing tests should be recommended from the age of 60 at the latest. Author(s) Source Döge J, Hackenberg B, O‘Brien K, Bohnert A, Rader T, Beutel ME, Münzel T, Pfeiffer N, Nagler M, Schmidtmann I, Wild PS, Matthias C, Bahr K Dtsch Arztebl Int 2023; 120: 99–106. DOI: 10.3238/arztebl.m2022.0385 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 17, 2023Key messages (zm): “Dental rehabilitation with dental implants in people with intermediate elevated blood glucose levels and diabetes mellitus is a safe and predictable procedure when properly indicated and a risk-based approach is used.” “In this context, diabetes mellitus should be classified as a potential risk indicator and this should be taken into account in patient management, treatment decisions as well as follow-up.” Author(s) Source DGZMK DGI et al. zm online 13.02.2023 AWMF Leitlinie Registerno. 083-025 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 10, 2023Internet has become an increasingly important resource for health information, especially for lay people. However, the information found does not necessarily comply with the user’s health literacy level. Therefore, it is vital to identify prominent information providers, quantify the readability of written health information, and to analyze how different types of information sources are suited for people with differing health literacy levels. We were able to identify major information hubs as well as topics and themes within the sGHW. Results indicate that the readability within the sGHW is low. As a consequence, patients may face barriers, even though the vocabulary used seems appropriate from a medical perspective. In future work, the authors intend to extend their analyses to identify trustworthy health information web sites. Author(s) Source Zowalla R, Pfeifer D, Wetter T PLoS ONE 18(2): e0281582. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0281582 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 3, 2023Many patients wait years for a donor organ. This could soon change. “In a few years, if a woman develops breast cancer, we can reconstruct her breast with real cells,” says von Arnim of the Cellbricks company. The team has provided proof that the reproduction of cells using printing processes works in initial research projects. Together with scientists from the Berlin Institute of Health at the Charité, Cellbricks has printed a biological wound closure, for example. Author(s) Source Handelsblatt Handelsblatt disrupt 03.02.2023 (german) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
February 2, 2023The healthcare sector needs digitization, that is undisputed. The focus of the public debate so far has been on efficiency gains and cost savings, as well as data-driven improvements in care. The potential is enormous, because digitization creates resilience and strengthens Europe’s economic sovereignty, and – most importantly – it can cushion the industry’s biggest problem: Staff shortages. Digital innovations offer the only chance to defuse this problem, which has not yet reached the public’s awareness clearly enough. Because speed in digitization is no longer a desirable goal, but a bitter necessity. The focus will have to shift to innovations that increase efficiency and thus save resources. In particular, the automation of documentation can free up personnel to a considerable extent. So it is specifically about data-driven innovation. However, access to health data by academic players and the resulting scientific publications will hardly help. Only speed and short development cycles can help – and these can only be achieved through competition and industrial solutions. Legal certainty and clear guidelines for the use of data are essential prerequisites for innovation. At the moment, however, we are seeing exactly the opposite, with the EU Commission presenting new regulations at an unprecedented pace: The Data Governance Act, the Data Act, the AI Regulation, and the European Health Data Space Regulation (“EHDS-VO-E”). Many of these regulations are being discussed in parallel at the European and national levels. As a result, it is difficult for most companies in the industry to imagine in concrete terms what these regulations might mean in practice for their own business. The following aspects of the draft are particularly critical: 1. citizens are literally disenfranchised, and the right to informational self-determination is lost. The scope of the consent-free secondary use of data is tantamount to a complete loss of control by those affected. 2. If this data is nationalized, a kind of data socialism is created. This is because the regulation created an obligation for companies to provide all health data to so-called “access points.” The obligation to disclose all data collected in primary use destroys the motivation to gain an edge, for example, in publishing research results, through the cost-intensive collection of particularly good and structured data – this inevitably weakens Europe as a business location. 3. The greatest danger is that the dystopia of the “transparent citizen” will come true. Despite the ban, re-identification cannot be ruled out and the privacy of those affected is at risk, because data leaks basically provide everyone with the necessary profiles for re-identification – and large platform companies have access to quite a bit of personal data anyway. Initially anonymized and basically pseudonymized individual data records can often be reassigned to the original persons by linking them with other data records. The broad provision of anonymized and pseudonymized individual data records envisaged by the draft regulation is therefore problematic. The problem of anonymized data sets Anonymization of health data describes the process by which the personal parts of a data record, which are usually sensitive and worthy of protection, are removed or changed. This ensures that they can no longer be assigned to the specific person, or only with disproportionate effort. This forms the basis of the secondary use of health data and pursues the goal of protecting the privacy of patients and preventing misuse. Anonymization can be reversed by selectively linking different data sets – so-called re-identification. The problem is not limited to the healthcare industry. A specific case arose in 2007, for example, when Netflix published ten million movie rankings. Although these were anonymized and identifying data was replaced by random numbers, researchers managed to de-anonymize parts of the dataset by matching them with rankings and their timestamps from other movie websites – personal data was revealed. Preventing the creation of user profiles is difficult given the complexity of the systems and algorithms used. In addition, it is difficult to prove illegal use of data or violations of competition law. Legal measures introduced subsequently have been ineffective to date because the massive networking of different areas of life has created dependencies that make subsequent unbundling impracticable. (editorially abridged) Author(s) Source Vilsmeier S (CEO of Brainlab AG) FAZ 28.02.2023 (“Digitalisierung Europas: Wie die EU-Kommission Gesundheitsdaten verstaatlicht (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
January 31, 2023Studies have shown that magnetic resonance imaging (MRI) does not have clinically important effects on the device parameters of non–MRI-conditional implantable cardioverter-defibrillators (ICDs). However, data on non–MRI-conditional ICD detection and treatment of arrhythmias after MRI are limited. During a median follow-up of 2.2 years from MRI to latest available ICD interrogation before generator or lead exchange in 536 patients, 4177 arrhythmia episodes were detected, and 97 patients received ICD shocks. Sixty-one patients (10% of total) had 130 spontaneous ventricular tachycardia or fibrillation events terminated by ICD shocks. A total of 210 patients (33% of total) are known to have died (median, 1.7 years from MRI to death); 3 had cardiac arrhythmia deaths where shocks were indicated without direct evidence of device dysfunction. Conclusion: Non–MRI-conditional ICDs appropriately treated detected tachyarrhythmias after MRI. No serious adverse effects on device function were reported after MRI. Author(s) Source Ra J, Oberdier MT, Suzuki M et al. Annals of Internal Medicine, 31.Jan 2023, https://doi.org/10.7326/M22-2653 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
January 30, 2023Medical devices such as insulin pumps, defibrillators and brain stimulators are getting more and more connectivity. As more and more patients receive implants to treat conditions ranging from diabetes and Parkinson’s disease to deafness and heart failure, implants are becoming more complex – and thus more wirelessly controllable. This means that smartphones could soon be able to manage devices such as pacemakers and insulin pumps very easily and conveniently. The therapy method from the field of functional neurosurgery is called deep brain stimulation (DBS). It involves sending electrical impulses to the brain to relieve symptoms of Parkinson’s disease, chronic pain, depression, tremors or other medical disorders. Once these devices are connected to the Internet, they can give rise to threats known as “brainjacking.” If an attacker then succeeds in cracking a device’s previously inadequate security measures, he has several options for manipulating his victim’s implant. In this way, hackers are able to control a person’s behavior. Since neurostimulators currently cannot provide reliable security, a secure communication channel between the device programmer and the neurostimulator must be established. This can be achieved with a shared session key and symmetric encryption. Two major challenges need to be addressed: Generation of the session key. Secure transmission of the session key to the other party. It is also helpful to have a low transmission power, which can only be received when there is direct contact. Author(s) Source Geißler O Security Insider 30.01.2023 (german) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
January 24, 2023An ALS patient set a record for communicating via a brain implant: 62 words per minute. Eight years ago, a patient lost her power of speech because of ALS, or Lou Gehrig’s disease, which causes progressive paralysis. She can still make sounds, but her words have become unintelligible, leaving her reliant on a writing board or iPad to communicate. Now, after volunteering to receive a brain implant, the woman has been able to rapidly communicate phrases like “I don’t own my home” and “It’s just tough” at a rate approaching normal speech. Author(s) Source Regalado A MIT Technology Review, January 24, 2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
January 21, 2023Speech brain-computer interfaces (BCIs) have the potential to restore rapid communication to people with paralysis by decoding neural activity evoked by attempted speaking movements into text or sound.Early demonstrations, while promising, have not yet achieved accuracies high enough for communication of unconstrainted sentences from a large vocabulary. Here, we demonstrate the first speech-to-text BCI that records spiking activity from intracortical microelectrode arrays. Finally, we highlight two aspects of the neural code for speech that are encouraging for speech BCIs: spatially intermixed tuning to speech articulators that makes accurate decoding possible from only a small region of cortex, and a detailed articulatory representation of phonemes that persists years after paralysis. These results show a feasible path forward for using intracortical speech BCIs to restore rapid communication to people with paralysis who can no longer speak. Author(s) Source Willett F, Kunz E, Avansino D et al. bioRχiv Jan 21, 2023, doi: https://doi.org/10.1101/2023.01.21.524489 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
January 13, 2023Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System Brain computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, non-randomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI. Results: From 2004 – 2021, fourteen adults enrolled in the BrainGate trial had devices surgically implanted. The average duration of device implantation was 872 days, yielding 12,203 days of safety experience. There were 68 device-related adverse events, including 6 device-related serious adverse events. The most common device-related adverse event was skin irritation around the percutaneous pedestal. There were no safety events that required device explantation, no unanticipated adverse device events, no intracranial infections, and no participant deaths or adverse events resulting in permanently increased disability related to the investigational device. Discussion: The BrainGate Neural Interface system has a safety record comparable to other chronically implanted medical devices. Given rapid recent advances in this technology and continued performance gains, these data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development. Author(s) Source Rubin DB, Ajiboye AB, Barefoot L et al. Neurology.org, January 13, 2023, DOI: https://doi.org/10.1212/WNL.0000000000201707 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
January 1, 2023Diabetics are known to frequently suffer from micro- and macroangiopathies. In addition, diabetes may be associated with increased wound healing disorders and compromised bone healing. Diabetes mellitus is therefore considered a relative risk factor for dental rehabilitation with implants, although dental implant surgery has emerged as a convenient oral rehabilitation tool in recent years. Against this background, the German Society of Implantology (DGI) and the German Society of Dental, Oral and Maxillofacial Medicine (DGZMK) have developed a current S3 guideline according to the guidelines of the Association of the Scientific Medical Societies (AWMF). Peri-implant infections after implant placement are particularly relevant in the presence of diabetes. Although the direct influence of diabetes mellitus on the development of peri-implant infections is not clear due to heterogeneous data, the risk of peri-implant infections seems to increase over time. The guideline recommends that patients with diabetes should be informed about the possibility of developing a peri-implant infection before starting therapy. The guideline provides recommendations for perioperative management in diabetics. For example, a disinfecting mouth rinse should be used perioperatively. In addition, the preoperative, prophylactic administration of a single antibiotic is recommended. There is no evidence in the literature that augmentation procedures have a higher complication and failure rate in patients with well-controlled diabetes mellitus compared to patients without diabetes mellitus. Patients with poorly controlled diabetes mellitus appear to have delayed osseointegration after implant placement; therefore, the indication for immediate and early loading should be particularly critical in these patients. The data on osseointegration in patients with well-controlled diabetes mellitus are very heterogeneous. However, after one year there seems to be no difference in implant stability between diabetics and healthy subjects. Overall, there are no significant differences in survival rates in the first years in patients with diabetes mellitus compared to the healthy comparison group. However, in the long-term course, the risk of implant loss still seems to be increased. Accordingly, a risk-oriented follow-up after implant placement should be performed. This also includes that the treating physician or dentist is informed about the patient’s HbA1c value and, if necessary, obtains further medical clarification. Author(s) Source editorial zm online 07/2023 (german original) german guideline 12-2022 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 31, 2022End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF). Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned. At 52 weeks, the scores improved for both groups. The adjusted difference showed that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups, but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF. Author(s) Source Goldberg AJ, Chowdhury K, Bordea E et al. Annals of Internal Medicine, 12-2022, https://doi.org/10.7326/M22-2058 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 31, 2022The guideline addresses nonsurgical and surgical therapies for peri-implant mucositis and perimplantitis on dental implants. The main findings are: Complete healing of peri-implant mucositis could not be predictably achieved in all patients after using both alternative and conventional biofilm removal procedures. Therefore, regular follow-up visits (e.g., every 3 months) should be scheduled for early detection of the need for retreatment. Alternative biofilm removal procedures should be used for non-surgical treatment of peri-implantitis. If the treatment objective cannot be achieved by nonsurgical therapy, advanced lesions in particular should receive early surgical therapy. For further information, please refer to the original text (see below). The guideline is valid from December 2022 to December 2027 Author(s) Source DGI, DGZMK et al. AWMF 2022 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 31, 2022Die Leitlinie beschäftigt sich mit nichtchirurgischen und chirurgischen Therapien der periimplantären Mukositis und Perimplantitis an Zahnimplanaten. Die wichtigsten Empfehlungen sind: Eine vollständige Abheilung der periimplantären Mukositis konnte sowohl nach Einsatz alternativer als auch konventioneller Verfahren zur Biofilmentfernung nicht bei allen Patienten vorhersehbar erreicht werden. Daher sollten regelmäßige Nachkontrollen (z.B. alle 3 Monate) zur frühzeitigen Erkennung des Bedarfs einer Nachbehandlung eingeplant werden. Bei der nichtchirurgischen Therapie der Periimplantitis sollten alternative Verfahren zur Biofilmentfernung zum Einsatz kommen. Wenn das Behandlungsziel durch eine nichtchirurgische Therapie nicht erreicht werden kann, sollten insbesondere fortgeschrittene Läsionen frühzeitig einer chirurgischen Therapie zugeführt werden. Für weitere Informationen wird auf den Originaltext verwiesen (s.u.) Die Leitlinie gilt von Dezember 2022 bis Dezember 2027 Author(s) Source DGI, DGZMK et al. AWMF 2022 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 27, 2022Objective The restoration of extraction sockets as a pre-implantological measure in preparation for implant placement is of great importance for implant placement success. Unlike a surgical incision, which can be adapted and primarily closed, there is no soft tissue in the region of a former tooth. Therefore, wound healing after tooth extraction, i.e. alveolar closure physiologically undergoes secondary wound healing. In this context, the body must both regenerate the bony defect and close the soft tissue defect by means of newly formed soft tissue. In this context, contraction of the defect takes place. This process often brings complications, which can jeopardize the success of the implant.Platelet-Rich-Fibrin (PRF) Blood concentrates and in particular Platelet-Rich-Fibrin (PRF) offer a treatment option for the regeneration of lost tissue. PRF is derived from the patient’s own blood. Applications of PRF in Dental Implantology Its bioactivity as well as the potential of releasing a number of growth factors makes it a useful tool in augmentative and regenerative restoration of various defects. PRF is used both as a stand-alone therapy and in combination with bone graft substitutes or membranes. Both alveolar closure in terms of soft tissue and bone regeneration play an important role and thus influence the success of dental implants. Especially routine restorations of pre-implantological therapy such as socket/ridge preservation or sinus floor elevation are frequent fields of application. Recommendations and statements Filling the alveolus with solid PRF plug matrix leads to improvement of alveolar healing and can be recommended in case of open healing alveolus. The sole use of solid PRF plug matrix to fill the alveolus contributes to volume preservation of the alveolar ridge and can be recommended as an alternative treatment option if socket/ridge preservation is indicated.No treatment recommendation can be made at this time for the following procedures (PRF with or without bone graft substitutes): Sinus floor elevation. Lateral, vertical and three-dimensional augmentation. Immediate implant placement. Peri-implant disease. No treatment recommendation can be made for the sole use of solid PRF plug matrix to fill the alveolus to reduce pain sensation. Author(s) Source Deutsche Gesellschaft für Implantologie im Zahn-, Mund- und Kieferbereich (DGI) Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde (DGZMK) DGZMK.de, S3 Leitlinie 12-2022 (german language) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 22, 2022Cochlear implants are not only used in children born deaf, but increasingly also in adults with hearing loss. The implants take over the function of the cochlea and bypass the sensory cells. Thus, they directly stimulate the nerve cells of the auditory nerve. A speech processor breaks down sound into its frequencies and transmits the frequency, time and volume information to the stimulator. After the insertion of electrical cochlear implants, patients have to relearn how to hear because the small number of electrodes severely limits the perception of different pitches. This is not always easy and not all patients are happy with the implants in the end. As with the conventional electrical cochlear implant, the optical method breaks down sound into frequency bands, but now into many more and finer ones: 64 light guides assigned to the frequency bands transmit light into the inner ear. In this way, the implants provide a hearing impression even when no sensory cells are intact. Initial tests with computer simulations and rodents show that the technology works. For low and medium volumes, the differentiation of pitches is hardly distinguishable from normal hearing. The first study in humans is scheduled to begin in 2026. Author(s) Source Pietschmann C, Moser T Max-Planck-Gesellschaft 22.12.2022 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 21, 2022Study identifies neurons that can improve sound perception, which could explain the variation in performance in people with cochlear devices. Stimulating neurons that are linked to alertness helps rats with cochlear implants learn to quickly recognize tunes, researchers have found. The results suggest that activity in a brain region called the locus coeruleus (LC) improves hearing perception in deaf rodents. Researchers say the insights are important for understanding how the brain processes sound, but caution that the approach is a long way from helping people. Cochlear implants use electrodes in the inner-ear region called the cochlea, which is damaged in people who have severe or total hearing loss. The device converts acoustic sounds into electrical signals that stimulate the auditory nerve, and the brain learns to process these signals to make sense of the auditory world. Some people with cochlear implants learn to recognize speech within hours of the device being implanted, whereas others can take months or years. “This problem has been around since the dawn of cochlear implants, and it shows no signs of being resolved” (Gerald Loeb, USCLA). Researchers caution that stimulating the LC in humans could be dangerous. The region sends signals to many brain regions, and regulates the fight-or-flight response. Stimulating the LC in people “would raise blood pressure and heart rate, and other autonomic responses”, says Graeme Clark, an otolaryngologist in the Graeme Clark Institute at the University of Melbourne, Australia, who developed the first multi-channel cochlear implant in the 1970s. “We would have to do a series of experiments to prove that it is something worth doing.” Author(s) Source Naddaf M nature, 21 Dec 2022 doi: https://doi.org/10.1038/d41586-022-04553-z This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 21, 2022Cochlear implants (CIs) are neuroprosthetic devices that can provide hearing to deaf people. Despite the benefits offered by CIs, the time taken for hearing to be restored and perceptual accuracy after long-term CI use remain highly variable. CI use is believed to require neuroplasticity in the central auditory system, and differential engagement of neuroplastic mechanisms might contribute to the variability in outcomes. Despite extensive studies on how CIs activate the auditory system, the understanding of CI-related neuroplasticity remains limited. One potent factor enabling plasticity is the neuromodulator noradrenaline from the brainstem locus coeruleus (LC). Here we examine behavioural responses and neural activity in LC and auditory cortex of deafened rats fitted with multi-channel CIs. Adequate engagement of central neuromodulatory systems is thus a potential clinically relevant target for optimizing neuroprosthetic device use. Author(s) Source Glennon E Valtcheva S, Zhu A, et al. Nature volume 613, pages317–323 (2023), https://doi.org/10.1038/s41586-022-05554-8 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...
December 14, 2022Deep brain stimulation (DBS) to the fornix is an investigational treatment for patients with mild Alzheimer’s Disease. Outcomes from randomized clinical trials have shown that cognitive function improved in some patients but deteriorated in others. This could be explained by variance in electrode placement leading to differential engagement of neural circuits. To investigate this, we performed a post-hoc analysis on a multi-center cohort of 46 patients with DBS to the fornix. Using normative structural and functional connectivity data, we found that stimulation of the circuit of Papez and stria terminalis robustly associated with cognitive improvement. On a local level, the optimal stimulation site resided at the direct interface between these structures. Finally, modulating specific distributed brain networks related to memory accounted for optimal outcomes. Findings were robust to multiple cross-validation designs and may define an optimal network target that could refine DBS surgery and programming. Author(s) Source Ríos AS, Oxenford S, Neudorfer C et al. Nat Commun 13, 7707 (2022). https://doi.org/10.1038/s41467-022-34510-3 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

 

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