NEWS
3D eye cells printed for the first time
A group of researchers from the UK have used 3-D biomedical printing to successfully print new eye cells www.3ders.org The ability to arrange cells into highly defined patterns and structures has recently elevated the use of 3D printing in the biomedical sciences to create cell-based structures for use in regenerative medicine. Original in IOPscience: Adult …
3D printing for hearing devices
3D printing assists implantation of hearing device A Kim “In all three cases, quick identification of the appropriate [bone implant] position was accomplished,” they wrote. “The transparent template enabled safe identification of the planned [bone implant] position on the temporal bone, previously localized on the 3D-printed model.” AuntMinnie, 4 Dec 2017 This is a post …
3D printing rapidly developing in life sciences
The “3D Printing for Life Sciences 2018” symposium topics: bioprinting, the medical devices industry and medical 3D printing. Sebastien Meunier Printing skin, muscle tissue or bone matter is already a reality, but you can’t yet print an organ, even though things are heading in that direction. Basel Area Innovation Report This is a post of …
3d-printed Bone
Hyperelastic “bone”: A highly versatile, growth factor–free, osteoregenerative, scalable, and surgically friendly biomaterial Jakus A et al. Despite substantial attention given to the development of osteoregenerative biomaterials, severe deficiencies remain in current products. These limitations include an inability to adequately, rapidly, and reproducibly regenerate new bone; high costs and limited manufacturing capacity; and lack of …
3D-printed titanium mesh implants
Study shows how 3D printed titanium-mesh implants can be optimized for better bone regeneration Tess A collaborative research team from Harvard’s Wyss Institute, the Julius Wolff Institute, the Berlin-Brandenburg Center for Regenerative Therapies, and Charité’s Center for Musculoskeletal Surgery has come together to study the benefits of 3D printed titanium-mesh scaffolds in implants. The preclinical …
A growth-accommodating implant for paediatric applications
Medical implants of fixed size cannot accommodate normal tissue growth in children and often require eventual replacement or—in some cases—removal, leading to repeated interventions, increased complication rates and worse outcomes. Feins EN et al. Implants that can correct anatomical deformities and accommodate tissue growth remain an unmet need. Here, we report the design and use …
A growth-accommodating implant for paediatric applications Read More »
Active Surveillance of Medical-Device Safety
Registry-Based Prospective, Active Surveillance of Medical-Device Safety Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand S-L, Matheny ME A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first …
Alloplastic substitution of the temporomandibular joint (german)
Alloplastischer Kiefergelenkersatz bei rheumatoider Erkrankung ZM 17/2017, online Die rheumatoide Arthritis ist eine Autoimmunerkrankung und kann im klinischen Verlauf von mildem Gelenkdiskomfort mit kurzer Dauer bis hin zu einer chronischen, stark schmerzenden Polyarthritis mit groben Missbildungen der Gelenke variieren. Patienten im Endstadium einer rheumatoiden Arthritis eignen sich zur chirurgischen Rekonstruktion des Kiefergelenks, um wieder eine …
Alloplastic substitution of the temporomandibular joint (german) Read More »
An 11- to 15-year clinical outcome study of a total knee arthroplasty
An 11- to 15-year clinical outcome study of the Advance Medial Pivot total knee arthroplasty Karachalios Th, Varitimidis S, Bargiotas K, Hantes M, Malizos KN Survival analysis at 15 years showed a cumulative success rate of 97.3% (95% confidence interval (CI) 96.7 to 97.9) for revision for any reason, of 96.4% (95% CI 95.2 to …
An 11- to 15-year clinical outcome study of a total knee arthroplasty Read More »
BIOCOMPATIBILITY OF PLASTICS
The International Organization for Standardization (ISO) presents widely adopted medical device guidelines that are aimed with a keen focus towards risk management. Biocompatibility testing for these devices and device components is addressed by ISO standard 10993. RESINATE 2017 Well-defined material characterization is a fundamental requirement in biocompatibility assessment. This evaluation consists of chemical, mechanical, …
Biomaterials Market – Global Forecast to 2020
Biomaterials Market by Type of Material & Application – Global Forecast to 2020 Markets and Markets, India Biomaterials Market Worth 130.57 Billion USD by 2020 Markets and Markets, Headquarter
Bioresorbable Scaffolds versus Metallic Stents in Routine PCI
In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through …
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Biphosphonates affect Dental Implants
Influence of Bisphosphonates on Implant Failure Rates and Characteristics of Postmenopausal Woman Mandibular Jawbone Yayima et al. The results indicate that BPs affect the quality and quantity of the cortical bone in the partially edentulous posterior mandible of patients with osteoporosis, which should be considered prior to treatment with dental implants in patients taking BPs. …
Bone tissue engeneering via ultrasound-mediated gene delivery
In situ bone tissue engeneering via ultrasound-mediated gene delivery to endogenous progenitor cells in mini-pigs Bez, Maxim, et al. Science Journal University of Leicester, Amgen, ORTHOfilms Science Translational Medicin 9.390 (2017)
Breast implants may falsify EKG (german)
Breast implants may hinder the EKG and show false heart attacks. Bun S-S A tram of cardiologists examined 50 women without heart problems, mean age of 42 years. 28 had beast implants. 57 % of EKG at breast implant patients have been valuated wrong. Deutsches Ärzteblatt 22. Juni 2017
Breast Implants: Update – Associated Anaplastic Large Cell Lymphoma
Breast Implants: Update – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) FDA FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest …
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CANADA: Medical Device Single Audit Program Transition Plan
CANADA: Medical Device Single Audit Program Transition Plan (FAQ) Health Canada clarification about the MDSAP Transition Plan from stakeholders as Health Canada moves towards the Medical Device Single Audit Program (MDSAP) Quality Systems Division, Medical Devices Bureau, Health Canada
Cardiopatch for heart tissue
Cardiopatch platform enables maturation and scale-up of human pluripotent stem cell-derived engineered heart tissues IY Shadrin et al. Despite increased use of human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) for drug development and disease modeling studies, methods to generate large, functional heart tissues for human therapy are lacking. Here we present a “Cardiopatch” platform for …
Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers
Published early in 2016, ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes establishes a new international framework to mitigate risk and produce effective medical devices. Christine Berard As the new standard now clarifies that a company’s QMS “shall meet customer and applicable regulatory requirements for safety and performance,” the time …
Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers Read More »
China Regulation of Medical Devices
Global Impact: China’s Regulations On The Supervision And Administration Of Medical Devices Yin A, Guo T, Rong M, Yang L, Smith R As China’s National Medical Products Administration (NMPA) moves closer to finalizing its 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices, medical device companies should be aware of …
Claims for faulty breast implants against French insurance fails in Germany
Pain and suffering claims for faulty breast implants against French insurance fails in Germany. Mitteilung A court in Hamm/Germany ruled in a decision published yesterday, that the liability insurer of a meanwhile broke French manufacturer not must be liable for damage caused by the faulty breast implants, if the operation in Germany took place (AZ. …
Claims for faulty breast implants against French insurance fails in Germany Read More »
Clinical Evaluation Reports under the EU MDR
Understanding Clinical Evaluation Reports under the EU MDR D Egbosimba Every medical device sold into Europe, new or existing, and irrespective of specification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. The manufacturer also needs to demonstrate that the device achieves its intended purpose and that any existing — …
COVID-19 (SARS-CoV-2, Coronavirus) – IMPLANT INFO LINKS
Information concerning the COVID-19-pandemic and implants Help. Send substantial links. General Dental E N T Esthetic Eye Neurology Surgery Urogenital General WHO World Health Organization (for the public) WHO World Health Organization (for health workers) WHO World Health Organization (technical guidance) The Joint Commission Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1 (New …
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Criminals fake implants with 3-D-tools
Darum gefährden 3-D-Drucker unsere Gesundheit Die Welt, Germany Criminals fake implants, protheses and pacemaker with 3-D-tools Carsten Dierig
Custom made subperiosteal oral implant enables to place definite fixed prosthesis in 6 weeks (german)
A custom made titanium subperiosteal mesh implant may help patients in hopeless cases. (german article) Gellrich N-C, Rahlf B The one-piece titanium fine-mesh implant is fixed with screws. Patients get a temporary denture for 6 weeks, thereafter a fixed bridge. This technique is helpful for elder or somehow sick patients, who are not willing to …
Custom-milled individual allogeneic bone grafts for alveolar cleft osteoplasty – A technical note
Surgeons from the Ludwig-Maximilians-University in Munich, Germany, showcase in this technical note the successful repair of an alveolar cleft using maxgraft® bonebuilder, an individualized allogeneic bone graft, in a 36-year old female patient with a 6-month-follow up showing good bony integration. Otto S et al. Today, bone grafts from the iliac crest are most …
Deaf children learn words faster than hearing children
According to estimates by the Robert Koch Institute, up to two thousand hearing impaired children are born in Germany each year. For some of them a cochlear implant can offer relief. Until now, it was not clear which processes take place in the affected children when they start to learn language later than their contemporaries …
Deaf children learn words faster than hearing children Read More »
Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure
Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure Lars Køber et al. In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. August 28, 2016, DOI: …
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Dentalpoint announces partnership with Nobel Biocare Services AG
As of today Dentalpoint AG announces partnership with Nobel Biocare Services AG to offer dental ceramic implants based on the Zeramex® technology.
DePuy ASR™ Hip Recall Guide
Informations about problems and recall details. In August 2010, DePuy Orthopaedics issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. Please select your country from the list below to learn more. Find information about possible symptoms, testing, treatment, and DePuy’s commitment to addressing reasonable and customary costs …
Diagnosing peri-implant disease using the tongue
Diagnosing peri-implant disease using the tongue as a 24/7 detector Nature Communications 8, Article number: 264 (2017) doi:10.1038/s41467-017-00340-x Our ability of screening broad communities for clinically asymptomatic diseases critically drives population health. Sensory chewing gums are presented targeting the tongue as 24/7 detector allowing diagnosis by “anyone, anywhere, anytime”. The chewing gum contains peptide sensors consisting of a …
Diagnosing peri-implant disease using the tongue Read More »
Digital Health Innovation Plan (FDA)
FDA can help encourage digital health innovation by redesigning our policies and processes and modernizing our tools so that they match the needs of digital health technology, and providing clarity on those policies and processes so that manufacturers and developers know what they need to do. We have designed this Action Plan to set forth …
Drug-coated balloons for small coronary artery disease
Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial Jeger RV, et al. In small native coronary artery disease, DCB was non-inferior to DES regarding MACE up to 12 months, with similar event rates for both treatment groups. The Lancet, Articles| Volume 392, ISSUE 10150, P849-856, September 08, 2018, https://doi.org/10.1016/S0140-6736(18)31719-7 This …
Drug-coated balloons for small coronary artery disease Read More »
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease Bonaa KH et al In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving …
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease Read More »
Drug-eluting stents (DES) superior versus bare-metal stents
In the ISAR-CABG (Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts?) trial, clinical outcomes at 1 year in patients undergoing treatment of saphenous vein graft lesions were superior with drug-eluting stents (DES) versus bare-metal stents. R Colleran et al. Patients were randomized (1:1:1:3) to receive DES (either permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting …
Drug-eluting stents (DES) superior versus bare-metal stents Read More »
Efficacy of restorative brain–computer interfaces
Investigating the impact of feedback update interval on the efficacy of restorative brain–computer interfaces Royal Society open science. 4:170660. https://dx.doi.org/10.1098/rsos.170660 Restorative brain–computer interfaces (BCIs) have been proposed to enhance stroke rehabilitation. Restorative BCIs are able to close the sensorimotor loop by rewarding motor imagery (MI) with sensory feedback. Despite the promising results from early studies, …
Efficacy of restorative brain–computer interfaces Read More »
Endoprosthesis Register (Germany) shows reasons for early replacements
Acute replacement of hip joint is followed by twice as much second replacement surgery as at standard scheduled surgery. 78.4% of hip endoprosthesis were placed without cementum. Accompanying illness like depression, overweight and diabetes influence the result. Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie The German Endprosthesis-Register (EPDR) lists for 5 years on a voluntary …
Endoprosthesis Register (Germany) shows reasons for early replacements Read More »
ESC/EACTS Guidelines for the management of valvular heart disease 2017
2017 ESC/EACTS Guidelines for the management of valvular heart disease European Heart Journal, Volume 38, Issue 36, 21 September 2017, Pages 2739–2791 The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) The disclosure forms of all experts involved in …
ESC/EACTS Guidelines for the management of valvular heart disease 2017 Read More »
Esophageal Organoids from Human Pluripotent Stem Cells
Esophageal Organoids from Human Pluripotent Stem Cells Delineate Sox2 Functions during Esophageal Specification SL Trisno et al. Highlights • Sequential Wnt, RA, and BMP signaling are required to pattern dorsal anterior foregut • Cultured dorsal anterior foregut spheroids develop into esophageal organoids (HEOs) • HEOs contain basal esophageal progenitors and stratified squamous epithelium • Sox2 …
Esophageal Organoids from Human Pluripotent Stem Cells Read More »
FDA: Reporting Allegations of Regulatory Misconduct
The FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for the FDA to understand the allegation and act on the report; however you can choose to submit a report anonymously. The FDA will not share your identity or contact information with anyone outside the FDA …
FDA: Reporting Allegations of Regulatory Misconduct Read More »
First 3D printed lower jaw implant in China
The first use of 3D printing technology for a lower-jaw reconstruction surgery in China was announced by Shanghai Medical Association, Dental Center at Military Hospital 411. www.3ders.org The patient, Ms. Sun, suffered from a tumor which caused serious damage to her lower jaw. She was discharged from the hospital on the third of January. ‘I didn’t …
Foramen Ovale Closure after Stroke
Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270.) Supported by St. Jude Medical. N Engl J Med 2017; 377:1022-1032September 14, 2017DOI: 10.1056/NEJMoa1610057 Among patients …
GDPR and Medical Devices
What Is GDPR’s (General Data Protection Regulation) Effect On Medical Devices? K Barchie Rights provided to data subjects reinforced via GDPR are: The right to be informed of the type of processing of their data that will be taking place The right to access and review the data that is being used to make decisions …
Genium knee joint – insurance (german)
Krankenkasse muss Kosten für Genium-Kniegelenk tragen Hessisches Landessozialgericht Das LSG Darmstadt hat entschieden, dass ein 82-jähriger Versicherter einen Anspruch auf eine Versorgung mit einem Genium-Kniegelenk anstelle mit einem C-Leg-Beinprothesensystem haben kann, wenn ihm das kostenaufwändigere Hilfsmittel einen wesentlichen Gebrauchsvorteil im Vergleich zur kostengünstigeren Alternative bieten kann, den er auch tatsächlich nutzen kann. Ein heute 82-jähriger …
Gentamicin coating of titanium alloy prevents implant-related osteomyelitis in rats
Gentamicin coating of plasma chemical oxidized titanium alloy prevents implant-related osteomyelitis in rats Biomaterials, Volume 101, issue 0, 156-164 Contamination of implants, bacterial load of bone powder and radiographic as well as histological signs of implant-related osteomyelitis were evaluated after four weeks. Gentamicin-SDS coating prevented implant contamination in 10 of 10 tibiae and gentamicin-tannic acid …
Gentamicin coating of titanium alloy prevents implant-related osteomyelitis in rats Read More »
German Ministry of Health announces national Implant-Register
German Ministry of Health announces law for national implant-register Ärzteblatt Following an inquiry of the german party FDP the ministry of health in Germany announced a blueprint for an implant-register to improve reliability of implants and medical treatment. This is a post of a scientific or business information. The information given here is checked thoroughly …
German Ministry of Health announces national Implant-Register Read More »
Green light for transplant registry in Germany
Grünes Licht für Transplantationsregister Dtsch Arztebl 2016; 113(29-30): A-1361 / B-1149 / C-1129 German politics agreed to install a transplant register. Richter-Kuhlmann, E-A.
Growth-accomodating implant for paediatric applications
A growth-accommodating implant for paediatric applications Feins E, et al. Medical implants of fixed size cannot accommodate normal tissue growth in children and often require eventual replacement or—in some cases—removal, leading to repeated interventions, increased complication rates and worse outcomes. Here, we report the design and use of a growth-accommodating device for paediatric applications that consists …
Growth-accomodating implant for paediatric applications Read More »
Hacking risk leads to recall of 500,000 pacemakers
Hacking risk leads to recall of 500,000 pacemakers due to patient death fears the guardian FDA overseeing crucial firmware update in US to patch security holes and prevent hijacking of pacemakers implanted in half a million people. Almost half a million pacemakers have been recalled by the US Food and Drug Administration (FDA) due to …
Hacking risk leads to recall of 500,000 pacemakers Read More »
Hydrophilicity, Viscoelastic, and Physicochemical Properties Variations in Dental Bone Grafting Substitutes
The indication-oriented Dental Bone Graft Substitutes (DBGS) selection, the correct bone defects classification, and appropriate treatment planning are very crucial for obtaining successful clinical results. Trajkovski B, Jaunich M, Müller W-D , Beuer F, Zafiropoulos G-G, Houshmand A We investigated the dimensional changes and molecular mobility by Dynamic Mechanical Analysis (DMA) of xenograft (cerabone®), synthetic (maxresorb®), …
Hyperelastic “bone”
Hyperelastic “bone”: A highly versatile, growth factor–free, osteoregenerative, scalable, and surgically friendly biomaterial Adam EJ et al What if we could create custom bone implants that would trigger their own replacement with real bone? Jakus and colleagues have done just this with a promising biomaterial that can be 3D-printed into many shapes and easily deployed …
Implant-Register reached 500 Companies
November 1st, 2017, Implant-Register® (implantwiki®) listed the 500th company dealing with implants
Implantable Artificial Kidney Could Enter Human Trials By 2017
A team of university scientists has developed the world’s first artificial kidney technology to be implanted in the body. Their bio-hybrid approach uses living kidney cells in tandem with a series of specialized microchips powered by the human heart to filter waste from the blood stream. The National Kidney Foundation estimates that over 100,000 patients …
Implantable Artificial Kidney Could Enter Human Trials By 2017 Read More »
Implantable Silicone
The use of implantable Silicone in medical devices sponsored After more than 50 years of using silicone rubber in medical implants, the number of applications for the material’s use in both short- and long-term implantable medical devices just keeps growing. With its long track record of biocompatibility, medical-grade silicone is being used in a range …
In laboratory breeded bone implanted
In Israel (Haifa) inlab breeded bone has been implanted to bridge 4cm bone defect in tibia Rozen N Bone was generated from patient´s fat cells and stem cells. Bone formation took two month. The process was developed by Bonus Biogroup. dpa/Dtsch Ärzteblatt
Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population
With the use of implanted cardiac monitors researchers found a substantial incidence (nearly 30 percent) of previously undiagnosed atrial fibrillation (AF) after 18 months in patients at high risk of both AF and stroke, according to a new study. Reiffel JA, Verma A, Kowey PR Results A total of 446 patients were enrolled; 233 (52.2%) …
Leadless pacing of hearts
Leadless pacing of hearts, experience and outlook (german) S Winter et al. First longterm results show constant performance. The one-chamber pacemakers are currently limited for elder patients. Application as two-chamber-systems may be possible in future Dtsch Arztebl 2017; 114(45): [12]; DOI: 10.3238/PersKardio.2017.11.10.03
Long-Term Cancer Risk Among Swedish Women With Cosmetic Breast Implants: An Update of a Nationwide Study
Epidemiologic evidence does not support a consistently increased cancer risk among women with cosmetic breast implants, but few studies have assessed risk beyond 15 years. McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nytren O Swedish women who underwent cosmetic breast implantation for the first time between January 1, 1965, and December 31, …
Long-Term Evaluation of ANKYLOS® Dental Implants
Long-Term Evaluation of ANKYLOS® Dental Implants, Part I: 20-Year Life Table Analysis of a Longitudinal Study of More Than 12,500 Implants Krebs M, Schmenger K, Neumann K, Weigl P, Moser W, Nentwig G-H Between April of 1991 and May of 2011, 12,737 ANKYLOS® (DENTSPLY Implants Manufacturing GmbH, Mannheim, Germany) implants were placed in 4,206 patients …
Long-Term Evaluation of ANKYLOS® Dental Implants Read More »
Mesh versus suture repair of umbilical hernia in adults
Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial Kaufmann R et al. Findings Between June 21, 2006, and April 16, 2014, we randomly assigned 300 patients, 150 to mesh repair and 150 to suture repair. The median follow-up was 25·1 months (IQR 15·5–33·4). After a maximum follow-up of …
Mesh versus suture repair of umbilical hernia in adults Read More »
More complications in heart valve surgery in the morning
Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbα antagonism: a single-centre propensity-matched cohort study and a randomised study Montaigne D et al. Perioperative myocardial injury is transcriptionally orchestrated by the circadian clock in patients undergoing aortic valve replacement, and Rev-Erbα antagonism seems to be a pharmacological strategy for cardioprotection. …
More complications in heart valve surgery in the morning Read More »
More Plastic Surgery worldwide in 2015
More Plastic Surgery worldwide in 2015 ISAPS, Dtsch Arztebl 2016 Isaps reported for 2015 1 million beauty treatments more than 2014 by esthetic surgeons, the total number rising from 20.2 to 21.7 million. Most favored surgeries were breast enlargements, fat removing, eyelid correction, belly rationalisation. ISAPS
More than 14.000 cases reported as problems with implants in Germany 2017
The number of the suspicion reports has tripled within the last ten years. Among other reasons these numbers can be explained with more frequently reports of doctors to the authorities and more frequent use of these products. It´s more critical with the group of the medical products with a high risk for the patient. …
More than 14.000 cases reported as problems with implants in Germany 2017 Read More »
Nasal chondrocyte-based engineered autologous cartilage tissue
Nasal chondrocyte-based engineered autologous cartilage tissue for repair of articular cartilage defects: an observational first-in-human trial Mumme M, Barbero A, Miot S, Wixmerten A, Feliciano S, Wolf F etal. Hyaline-like cartilage tissues, engineered from autologous nasal chondrocytes, can be used clinically for repair of articular cartilage defects in the knee. Future studies are warranted to …
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Neural Bypass Technology
Battelle NeuroLife™ Neural Bypass Technology Batelle Battelle has developed a breakthrough technology that empowers paralyzed patients to regain conscious control of their fingers, hand and wrist. The Battelle NeuroLife Neural Bypass Technology skips damaged areas of the nervous system to allow the brain to communicate directly with muscles. Med Device Online Original: Nature 2016
Neuromodulation of lumbosacral spinal networks after complete paraplegia
Neuromodulation of lumbosacral spinal networks enables independent stepping after complete paraplegia L Megan et al. Spinal sensorimotor networks that are functionally disconnected from the brain because of spinal cord injury (SCI) can be facilitated via epidural electrical stimulation (EES) to restore robust, coordinated motor activity in humans with paralysis1,2,3. Previously, we reported a clinical case …
Neuromodulation of lumbosacral spinal networks after complete paraplegia Read More »
New pacemaker without battery
Neuartiger Herzschrittmacher ohne Batterie Bionity.com, XING-news Eine Mini-Turbine gewinnt aus dem Blutstrom ausreichend Energie, um einen Herzschrittmacher ohne Elektroden und ohne Batterie zu betreiben. Das torpedoförmige Implantat hat einen Durchmesser von 6,2 Millimetern. Über eine magnetische Kupplung treibt das Schaufelrad einen Mikrogenerator im Inneren des Gehäuses an und generiert so die benötigte elektrische Energie. Das …
Osteogain® loaded onto an absorbable collagen sponge
Osteogain® loaded onto an absorbable collagen sponge induces attachment and osteoblast differentiation of ST2 cells in vitro. Miron et al. RESULTS: ACS efficiently loaded nearly 100% of the amelogenin proteins found in Osteogain® which were gradually released up to a 10-day period. Osteogain® also significantly induced a 1.5-fold increase in cell attachment and resulted in …
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Outcomes for Absorb Stent Acceptable at One to Two Years, with Caveats
Patients receiving the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS), a dissolving stent to open clogged vessels around the heart, showed outcomes comparable with patients receiving the Xience drug-eluting metal stent between years one and two. Ellis S However, patients receiving Absorb BVS faced an overall elevated risk of adverse outcomes at two years compared with …
Outcomes for Absorb Stent Acceptable at One to Two Years, with Caveats Read More »
Parkinson’s disease: Better overall behavioural outcomes with bilateral subthalamic stimulation plus medical therapy
Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson’s disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial Lhommée E et al. In a large cohort with Parkinson’s disease and early motor complications, better overall behavioural outcomes were noted with bilateral subthalamic stimulation plus medical …
Patient Dissatisfaction Following Total Knee Arthroplasty
Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature R Gunaratne et al. Dissatisfaction following total knee arthroplasty (TKA) is common. Approximately 20% of patients report dissatisfaction following primary TKA. This systematic literature review explores key factors affecting patient dissatisfaction following TKA. This review found that patient dissatisfaction pertains to several …
Patient Dissatisfaction Following Total Knee Arthroplasty Read More »
Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature
Dissatisfaction following total knee arthroplasty (TKA) is common. Approximately 20% of patients report dissatisfaction following primary TKA. R Gunaratne, DN Pratt, J Banda, DP Fick, RJK Khan, BW Robertson This review found that patient dissatisfaction pertains to several key factors. Patient expectations prior to surgery, the degree of improvement in knee function, and pain relief …
Patients of faulty hip implants can seek damages
India: All patients of DePuy ASR™´s (Johnson and Johnson) faulty hip implants can seek damages Teena Tacker New Delhi: Anyone suffering from faulty hip implants by pharma giant Johnson and Johnson Pvt. Ltd (J&J) can apply for compensation, and not just those who have undergone revision surgery, the chairman of the central expert committee on …
Patients of faulty hip implants can seek damages Read More »
Peri-implant tissue conditions in implants placed with simultaneous augmentation procedure
Investigation of peri-implant tissue conditions and peri-implant tissue stability in implants placed with simultaneous augmentation procedure: a 3-year retrospective follow-up analysis of a newly developed bone level implant system Lorenz J, Lerner H, Sader RA, Ghanaati S Results The follow-up investigation revealed a survival rate of 100% and only low median rates for probing depths …
Proprioception from a neurally controlled lower-extremity prosthesis
Although there have been many attempts to create human-mechatronic interactions, there is still no robust, repeatable methodology to reflect proprioceptive information from a synthetic device onto the nervous system. To address this shortcoming, we present an agonist-antagonist myoneural interface (AMI). The AMI is composed of (i) a surgical construct made up of two muscle-tendons—an …
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Regulation on Medical Devices Europe (MDR) causes unrest
Regulation on Medical Devices Europe (MDR) causes unrest ÄrzteZeitung A deficit of qualified employees and the reduced number of notified bodies could result in a shortage of new registrations, hindering manufacturers to introduce new products. This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we …
Regulation on Medical Devices Europe (MDR) causes unrest Read More »
Release of chlorhexidine from titanium dental implant
Controlled release of chlorhexidine from a mesoporous silica-containing macroporous titanium dental implant prevents microbial biofilm formation K De Cremer, A Braem, E Gerits, K De Brucker, K Vandamme, JA Martens, J Michiels, J Vleugels, BPA Cammue, K Thevissen Roughened surfaces are increasingly being used for dental implant applications as the enlarged contact area improves bone cell …
Release of chlorhexidine from titanium dental implant Read More »
Reliability In Medical Electronic Devices
Redefining Reliability In Medical Electronic Devices Subrahmanyan R, Sporon-Fiedler F, Primavera A, Shen D Micro Systems Engineering (MSEI), a subsidiary of Micro Systems Technologies (MST), has developed a systematic, end-to-end advanced reliability methodology (e2ARM) that focuses on the application of reliability technologies throughout a device’s lifecycle MED DEVICE ONLINE July 20,2016 This is a post …
Robotic System for Dental Implants
FDA Clears First Robotic System For Dental Implant Procedures MED DEVICE ONLINE The FDA has approved “game-changing” technology that provides pre-operative and intra-operative guidance for surgeons performing dental implant procedures. The robotic navigation system from Neocis — called Yomi — can reduce surgery time and improve accuracy compared to procedures performed free-hand, said Neocis CEO …
Samara University presents anatomically adapted implants
Samara University presents anatomically adapted implants made by selective laser fusion technology Samara University, Russia, 443086 Samara, ssau@ssau.ru Presented were anatomically adapted endoprosthesis of pelvic ring bones and cervival spine vertebra Presentation at the iENA, Nurembeg, GERMANY 2017
Satisfaction with Total Knee Prosthesis (german)
Satisfaction with Knee-TEP depends mostly from expectations, grade of functional improvement and pain course. Roland Fath Laut einem systematischen Literatur-Review mit Daten von 2005 bis 2016 hängt die Zufriedenheit von Patienten mit Knie-TEP in erster Linie von den Erwartungen vor dem Eingriff, vom Ausmaß der Funktionsverbesserung und dem Schmerzverlauf ab (2). Bei korrekter Indikation, chirurgisch …
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Silica sol-gel hybrid coatings for metal implants
Control of the degradation of silica sol-gel hybrid coatings for metal implants prepared by the triple combination of alkoxysilanes Romero-Gavilán F, Barros-Silva S, García-Canadas J, Palla B, Izquierdo R, Gurruchaga M, Goñi M, Suay J Development of new hybrid sol-gel coatings based on triple mixtures of alkoxysilanesTEOS alkoxysilane ability to tune sol-gel DegradationProtective behavior of MTMOS:GPTMS:TEOS coatingsA compromise between metal protection and silica sol-gel …
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Spiral pressure cardiac biventricular assist device presented (Cardiotwist)
Cardiotwist device is an extra cardiac biventricular assist device for chronic or acute heart failure patients. Dr. Mahdi Daliri (Tehran, IRAN), m_daliri@yahoo.com The device helps the muscles of right and left ventricular with spiral pressure from outside and increases the output. presented at the iENA, Nuremberg (GERMANY) 2017
Study shows benefits to treating all clogged arteries at once after heart attack
Fractional Flow Reserve–Guided Multivessel Angioplasty in Myocardial Infarction Smits P et al. Patients experiencing a major heart attack often have more than one clogged artery, but under current guidelines doctors typically only clear the blockage responsible for the heart attack. Assessing and, when warranted, treating the additional blockages can improve patient outcomes and reduce the …
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Temporal Sensitivity Measured Shortly After Cochlear Implantation
Temporal Sensitivity Measured Shortly After Cochlear Implantation Predicts 6-Month Speech Recognition Outcome. Erb L, Kunke D, Fuchs M, Obleser J Both AMRD thresholds at t0 (r = -0.51) and speech recognition scores at t0 (r = 0.56) predicted speech recognition scores at t6. However, AMRD and speech recognition at t0 were uncorrelated, suggesting that those …
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Tissue-engineered intervertebral disc implant
Long-term mechanical function and integration of an implanted tissue-engineered intervertebral disc Gullbrand SE, Ashinsky BG, Bonnevie ED et al. Intervertebral disc degeneration causes back and neck pain, sometimes necessitating disc fusion surgery. Although fusion may alleviate symptoms, it does not address the underlying cause of degeneration. As an alternative to fusion, Gullbrand and colleagues developed …
Tongue pacemaker which allows MRT
A new system of tongue pacemaker which allows to make MRT was implanted at University Clinic, Innsbruck, Austria Schwamberger The first tongue pacemaker was implanted in 2015 to treat a certain sleep apnoea. The former system did not allow MRT because of strong magnet field. The new system solves this problem Tirol Kliniken This is …
Total Knee Replacement – Computer-Assisted versus Conventional
Computer-Assisted Compared with Conventional Total Knee Replacement G Petursson et al. In this study, the use of computer navigation provided better pain relief and restored better function than the use of the conventional surgical technique at 2 years after total knee replacement. The Journal of Bone and Joint Surgery, 2018 Aug 1; 100 (15): 1265, …
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Transcatheter Mitral Valve Technologies
Transcatheter Mitral Valve Technologies: The Heart of Cardiovascular Device Innovation Bawa TS, Hoffmann M, Thompson S, Kwei S The current atmosphere in medical device investment is one of caution: Over the last five years, about two-thirds of high-impact medical device M&A deals have occurred following U.S. commercialization1, that is, after targets had already generated the …
US scientists design an artificial kidney with Nano filters that could replace dialysis
The artificial kidney, about to enter its testing phase in humans, will combine electronic and organic elements, and will be similar in size to organs whose function it will assume. This will be a huge improvement for the lives of those who need to connect several times a week to an external hemodialysis device because …
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Use of Collagen, PTFE and PRF Membranes in Bone Reconstruction
Use of Collagen, PTFE and PRF Membranes in Bone Reconstruction an Experimental and Histomorphometric Study Neculae et al. In the present study it can be noted that bone regeneration differs depending on the type of barrier membranes used. There is an advantage of collagen membranes compared to non-resorbable d-PTFE membranes. The use of PRF membrane …
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Vaginal mesh implants, Problems, Class action
Vaginal mesh implants: Class action against Johnson and Johnson begins in Federal Court Sophie Scott, Alison Branley A class action involving more than 700 women has begun, with legal representatives for the women claiming the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh. ABC News Jul 04, 2017
Wait time for hip fracture surgery – association
Association Between Wait Time and 30-Day Mortality in Adults Undergoing Hip Fracture Surgery D Pincus et al. Among adults undergoing hip fracture surgery, increased wait time was associated with a greater risk of 30-day mortality and other complications. A wait time of 24 hours may represent a threshold defining higher risk. JAMA. 2017;318(20):1994-2003. doi:10.1001/jama.2017.17606
White paper for Cochlea Implants (GERMANY)
Weißbuch Cochlea-Implantat(CI)-Versorgung Das Präsidium der DGHNO KHC Empfehlungen zur Struktur, Organisation, Ausstattung, Qualifikation und Qualitätssicherung in der Versorgung von Patienten mit einem Cochlea-Implantat in der Bundesrepublik Deutschland April, 2018 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 …
Wireless bioresorbable electronic system
Wireless bioresorbable electronic system enables sustained nonpharmacological neuroregenerative therapy Koo J, MacEwan MR, Rogers JA Peripheral nerve injuries represent a significant problem in public health, constituting 2–5% of all trauma cases. For severe nerve injuries, even advanced forms of clinical intervention often lead to incomplete and unsatisfactory motor and/or sensory function. Numerous studies report the …
World´s first implantable artificial kidney
World’s First Implantable Artificial Kidney Could Enter Human Trials By 2017 Suzanne Hodsden A team of university scientists has developed the world’s first artificial kidney technology to be implanted in the body. Their bio-hybrid approach uses living kidney cells in tandem with a series of specialized microchips powered by the human heart to filter waste …
worldwide markets for Dental Implants 2015-2022
worldwide markets for Dental Implants 2015-2022 reportbuyer This report analyzes the worldwide markets for Dental Implants in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. …
Xenogeneic bone grafting materials
Nowadays, a variety of bone substitutes are available for the clinical user. Interestingly, these materials significantly differ regarding their raw materials or manufacturing processes. As an alternative to autologous bone tissue (autograft), which is still applied as “gold standard” due to its extensive regenerative properties, bone substitutes from other natural sources become more and more …