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2 million joint replacement surgeries recorded in the german endoprosthesis register

Ten years after its launch, the Endoprosthesis Register Germany (EPRD) has now surpassed the two-million mark in the recording of surgical documentation. This can be a reliable database for assessing hip and knee endoprosthetic care in Germany. The voluntary data supplied by more than 780 hospitals cover more than 70...

3-D printing market grows by 25 percent annually

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3D bioprinting rebuilding components of the human heart

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3D blood vessel printing (research)

Scientists in Kiel have developed a innovative 3D bio-printer to create fine blood vessels for bypass implants. "Especially for heart patients who do not have suitable endogenous veins for harvesting a bypass vessel, this new procedure could represent an enormous advance for heart bypass surgery, particularly in terms of patient...

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...

3D printing enters brave new world

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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...

3D Printing of Heart

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3D printing of soft robotic systems

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3D Printing Plasma Jetting Method for Bone Implants

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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...

3D printing technologies for soft and hard tissue regeneration

Typically, manufacturing technology is done in four steps: creating or scanning, converting to a file, specifying the print material, and manufacturing. The production of artificial tissues using 3D printing is known as bioprinting. The most common method is the top-down approach. Recently, the bottom-up proceeding has also been successful. Certain...

3D printing technology could save animal testing

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3D printing to aid tissue replacement

Professor Arda Gozen looks to a future someday in which doctors can hit a button to print out a scaffold on their 3-D printers and create custom-made replacement skin, cartilage, or other tissue for their patients. Gozen, George and Joan Berry associate professor in the Washington State University School 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...

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...

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...

A Road Map To China’s Medical Device Registration Process

China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world, following closely behind the U.S. From 2015 to 2019, the CAGR for the Chinese medical devices market has increased significantly, and it is expected to continue rising even more in the...

A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict “Unpredictable” Complications?

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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...

Adverse events of reoperation after elective shoulder replacement

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Affection of Cardiac pacemakers and defibrillators by electromagnetic fields in everyday life

Cell phone safety distance Modern cell phones and smartphones with Internet function pose only a very low interference risk. A safety distance of 15 cm from the implant, as recommended ago, is no longer necessary due to the telephony and Internet function. However, pacemaker and ICD wearers should maintain a...

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...

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...

An enzymatic pathway that converts A to universal O type blood

An enzymatic pathway in the human gut microbiome that converts A to universal O type blood Access to efficient enzymes that can convert A and B type red blood cells to ‘universal’ donor O would greatly increase the supply of blood for transfusions. Here we report the functional metagenomic screening...

Anaplastic large cell lymphoma from breast implants

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Annual report 2019 of the Endoprostheses Register Germany (EPRD)

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Anti-Inflammatory Activity of Heparin- and Hyaluronan-Containing Multilayer Coatings

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Antibacterial Envelope of Cardiac Implantable Device

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Antihypertensive Medications and the Survival Rate of Osseointegrated Dental Implants

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Auditory brainstem implants – hearing restoration in congenitally deaf children

Children born deaf can learn to hear and speak with a cochlear implant (CI). If implantation of a CI is impossible for anatomical reasons, the auditory brainstem implant (ABI) is the only surgical alternative for hearing rehabilitation. Calculations show that about 5-45 children in Germany could be eligible for this...

Auricular prostheses attached to osseointegrated implants

Different causes of an absent auricle exist and can mainly be divided into congenital and acquired. Not long after the introduction of osseointegrated implants outside the oral cavity, auricular prostheses are retrained on osseointegrated implants (Vistafix® system, VXI implant). In total, 31 implants were placed in 11 patients. None of...

Autonomous robotic intracardiac catheter navigation

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Avoid Compliance & Timeline Risks Whith Medical Device Supplier

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Axial alignment is a critical regulator of knee osteoarthritis

Although osteoarthritis (OA), a leading cause of disability, has been associated with joint malalignment, scientific translational evidence for this link is lacking. In a clinical case study, we provide evidence of osteochondral recovery upon unloading symptomatic isolated medial tibiofemoral knee OA associated with varus malalignment. Therapeutic unloading shifted the articular...

Bacterial communities in early biofilm formation on dental implants restored with titanium or zirconia abutments

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Beinlängendifferenz – Therapieindikationen und -strategien

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Binaural squelch and head shadow effects in children with unilateral cochlear implants and contralateral hearing aids

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Bio-functionalization of grade V titanium alloy with human type I human collagen

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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...

Biocompatible mini energy storage device for direct diagnosis in the body

Miniatur-Sensoren, die Vitalwerte direkt im Körper bestimmen sollen, sind hochkomplexe Systeme. Eine der größten Hürden stellt die Energieversorgung dar. An der TU Chemnitz haben Wissenschaftler jetzt Energiespeicher entwickelt, die zwar nur so groß wie ein Staubkorn sind, aber Spannungen vergleichbar mit einer AAA-Batterie liefern. Biosuperkondensatoren (BSCs)“. Sie besitzen zwei herausragende...

Biofilm formation on metal alloys, zirconia and polyetherketoneketone as implant materials in vivo

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Bioink for Printing 3D Cardiac Constructs

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Bioinspired Heart Valve Prosthesis (Silicone, Additive Manufacturing)

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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

Biomimetic 3D-printed scaffolds for spinal injury repair

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Bionic eyes are now obsolete and unsupported

Second Sight left users of its retinal implants in the dark A patient reported, that her Argus retinal implant system went down and the patches of light and dark that she’d been able to see with the implant’s help vanished. She found that the company had abandoned the technology and...

bioprinting tissue-like constructs capable of controlled, complex shape change

Where standard 3D printing uses a digital blueprint to manufacture an object out of materials like plastic or resin, 3D bioprinting manufactures biological parts and tissues out of living cells, or bioinks. A fourth dimension — shape transformation over time — can be achieved by incorporating materials that enable printed...

Bioprinting- 3D printing of lung scaffolds

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Bioprinting: Where do your bones come from?

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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...

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...

Bone growth inspired “microrobots” that can create their own bone

Inspired by the growth of bones in the skeleton, researchers at the universities of Linköping in Sweden and Okayama in Japan have developed a combination of materials that can morph into various shapes before hardening. The material is initially soft, but later hardens through a bone development process that uses...

Bone Resorption During Submerged Healing After Guided Bone Regeneration : A Prospective Case Series

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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)

Brain implant enables ALS patients to communicate with the world outside

A patient in the advanced stages of amyotrophic lateral sclerosis (ALS) who had lost his last ability to communicate with the outside world after paralyzing his eye muscles has learned to make himself heard again with the help of a brain-computer interface. Nach dem in Nature Communications (2022; DOI: 10.1038/s41467-022-28859-8) vorgestellten Fall­bericht konnte...

Breast implant tourism in Tunesia

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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...

C. R. BARD discontinues selling vaginal mesh products globally

Leading manufacturer exits vaginal mesh market globally Bard halted the use of certain mesh products in the United States in 2012. Since then, Bard has paid out hundreds of millions of dollars in settlements and damages in the U.S. to women who said they were harmed by mesh. The company...

Call-back of pacemakers

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Canada acts on Implant Files

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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...

Cemented or Uncemented Hemiarthroplasty for Intracapsular Hip Fracture

Controversy exists over the use of bone cement in hip fractures treated with hemiarthroplasty. Only limited data on quality of life after cemented as compared with modern uncemented hemiarthroplasties are available. Among patients 60 years of age or older with an intracapsular hip fracture, cemented hemiarthroplasty resulted in a modestly...

Challenges To The Orthopedic Biomaterials Market In 2019

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Changes of clinically failed SLA implants after in vitro debridement

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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...

Characteristics of Health Care Personnel with COVID-19 (U.S.A.)

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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...

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...

Clinical approach of ceramic dental implants

Ceramic implants establish in modern dental implantology as a supplement to the treatment spectrum with titanium implants. An increasing interest can be observed not only on the part of health-conscious patients, but also in the dental profession due to the biological advantages. The large number of participants in an extensive...

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...

Clinical trial evaluating the effects of two different implant collar designs after 25 years

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Closed-loop neuromodulation in an individual with treatment-resistant depression

Deep brain stimulation is a promising treatment for neuropsychiatric conditions such as major depression. Closed-loop therapy resulted in a rapid and sustained improvement in depression. Future work is required to determine if the results and approach of this n-of-1 study generalize to a broader population. Author(s) Source Scangos KW, Khambhati AN,...

Cochlear implantation – diagnosis, indications, and auditory rehabilitation results

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Cochlear optogenetics – spectral selectivity

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Comparative chemical evaluation of two derivatives of hyaluronic acid (Hylaform®, Restylane®)

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Comparison Between a Computer-Aided Surgical Template and the Free-Hand Method

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Comparison of a polyethylene glycol membrane and a collagen membrane for the treatment of bone dehiscence defects

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Complete Revascularization with Multivessel PCI for Myocardial Infarction

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Compliance with legal requirement to report clinical trial results on ClinicalTrials

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Complications with an implantable insulin pump

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Concerns about paclitaxel-coated stents and balloons removed

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Consent for chip implants in the population increases

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Controlled release of soy isoflavones from multifunctional 3D printed bone tissue engineering scaffolds

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Converting blood type A donor lungs into universal blood type lungs

Ex vivo enzymatic treatment converts blood type A donor lungs into universal blood type lungs A major challenge in lung transplantation is the need for ABO blood group matching. To address this challenge, Wang et al. used two enzymes, FpGalNAc deacetylase and FpGalactosaminidase, to convert blood group A lungs to blood group...

Corona infection at the dentist: How high is the risk?

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Court orders TÜV to pay damages in breast implant scandal

According to the verdict published the previous day, around 1,600 plaintiff women are to receive provisional compensation of 5,150 euros each, or a total of around 8.2 million euros. Within two years, an expert is to investigate the matter further. TÜV announced that it would appeal against the decision in...

COVID-19 (SARS-CoV-2, Coronavirus) – IMPLANT INFO LINKS

Information concerning the COVID-19-pandemic and implants  Help. Send substantial links. General Dental ENT 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...

COVID-19 (SARS-CoV-2, Coronavirus) – LINKS

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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

Current Standard in Shoulder Replacement (2003)

Main indications for shoulder replacement are osteoarthritic joint changes due to rheumatoid arthritis, degenerative joint disease or complex proximal humerus fractures. In general shoulder endoprostheses are differentiated into constraint and non-constrained implants. Today, mostly non-constrained implants are used which are hemi-endoprostheses in most of the cases. With modern implants good...

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,...

Custom-made silicone heart valves

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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...

Dangerous information deficit on implants (implant files, german)

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Dassault Systèmes’ Living Heart Project Reaches Next Milestones

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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...

Defective hip prosthesis: manufacturer must pay damages for pain and suffering

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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...

Defining Quality Indicators for Breast Device Surgery: Registries for Global Benchmarking

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Dental companies to make changes to their product range

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Dental implant failure rates in patients with self-reported allergy to penicillin

In a number of previous studies, patients with reported penicillin allergies have been documented to experience higher rates of dental implant failure than those who had not reported this allergy. The authors of this study aimed to determine whether an increased risk of implant failure is associated with patient-reported penicillin...

Dental implant prosthetic rehabilitation of a patient with epidermolysis bullosa dystrophica

Some rare diseases with oral manifestations warrant fixed/implant-supported restorations - a case report Epidermolysis bullosa dystrophica (DEB) describes a form of hereditary epidermolysis bullosa (EB), which is characterized by fragility of the skin and mucous membranes and manifests itself with blistering. In connection with dental and oral surgical procedures, blistering...

Dental Implant Software – List

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Dental Implants in Times of Coronavirus

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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.

Depression, Antidepressants, and Bone Health in Older Adults

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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...

Deutsches Implantateregister soll 2023 in Betrieb gehen (german text)

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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...

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...

Digital light 3D printing of customized bioresorbable airway stents

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Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA

The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers. The FDA is aware...

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,...

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...

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...

Early Implant Failures Related to Individual Surgeons: An Analysis Covering 11,074 Operations Performed during 28 Years

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Effect of Implantable vs Prolonged External Electrocardiographic Monitoring on Atrial Fibrillation Detection in Patients With Ischemic Stroke

Question  What is the rate of detection of atrial fibrillation with use of an implantable electrocardiographic monitor for 12 months vs use of prolonged external electrocardiographic monitoring for 30 days after an ischemic stroke? Conclusions and Relevance  Among patients with ischemic stroke and no prior evidence of AF, implantable electrocardiographic monitoring for...

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension

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Efficacy and Safety of Vertebral Augmentation

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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...

Electromagnetic interference of active heart rhythm implants in everyday life and at work

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Empfehlung für die Verwendung von Paclitaxel-beschichteten Stents (DES) und Ballons (DCB) in der Behandlung der peripheren arteriellen Verschlusskrankheit (pAVK) (german)

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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...

Endoprosthetics and sports: What is possible, what makes sense, what is taboo?

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Endoprosthetics: Active role of the patient required

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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...

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...

EU CED: Implant certificate for dental implants (passport)

The Council of European Dentists decided in 2020 that, according to the Medical Devices Regulation, an implant passport must be given to a patient. This should clearly identify the implant. Healthcare providers will be obliged to provide patients with such a passport. Implant Register: The easiest way is to download...

EU CED: Implantatpass für Zahnimplantate

Das Council of European Dentists beschloss, dass gemäß Medizinprodukteverordnung einem Patienten ein Implantatpass auszuhändigen ist. Dieser soll das Implantat eindeutig identifizieren. Gesundheitsdienstleister werden verpflichtet den Patienten einen solchen Ausweis auszuhändigen. Implant-Register: Der einfachste Weg ist es, den Implantatpass im Register herunterzuladen und auszudrucken. Der download ist hier.

EU intends to postpone medical devices regulation by one year

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EU Medical Device Regulation (MDR) with far-reaching impact for device manufacturers doing business in Europe

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EU parliament postpones Medical Devices Regulation (MDR) for one year.

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EU-Medizinprodukte-Verordnung – MDR 2020: Was erwartet Zahnärzte (Red.: Einführung auf 2021 verschoben) (german)

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EU: Use of Symbols to Indicate Compliance with the Medical Devices Regulation

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Eudamed database: Registration as economic operator possible from 01.12.20

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Europe: Authorities judge cancer danger at breast implants differently

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Europe: Dental companies to make changes to their product range

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Europe: Patient care with innovative medical products will become more difficult

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European Commission names UDI Issuing Agencies

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Evaluation of Changes in Functional Status in the Year After Aortic Valve Replacement

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Evidence- and consensus-based indication criteria for total hip arthroplasty for coxarthrosis

Implantation of a total hip arthroplasty (hip TEP) is the most common endoprosthetic procedure in Germany. However, there are significant regional differences in the frequency of treatment. Despite predominantly very good results, risks are also associated with this intervention. The correct indication is therefore of great importance for the individual...

Examining FDA’s New Patient Labeling Draft Guidance

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FDA again warns against Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)

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FDA challenged over metal implants ‘public health travesty’

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FDA stops sales of urogynecologic surgical mesh implants

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FDA: Known risk of lymphoma from breast implants

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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...

FDA: Unique Device Identification

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FDA’s “Data Effect” Tsunami – Steps To Prepare

The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan (TMAP). Announced on March 3, 2021, DMAP is the agency’s overhaul of technology and data with the objective of bringing together increasingly disparate and diverse data sources to help understand and pinpoint emerging...

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...

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease

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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...

FRESH 3D Bioprinting a Full-Size Model of the Human Heart

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Fully implantable and bioresorbable cardiac pacemakers without leads or batteries

Temporary cardiac pacemakers used in periods of need during surgical recovery involve percutaneous leads and externalized hardware that carry risks of infection, constrain patient mobility and may damage the heart during lead removal. Here we report a leadless, battery-free, fully implantable cardiac pacemaker for postoperative control of cardiac rate and...

Fully implantable cochlear implant placed

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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...

General versus Local Anesthesia with Conscious Sedation in Transcatheter Aortic Valve Implantation

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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...

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...

German government decides on a national implant patient registry

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German insurance companies enter into a framework agreement for quality assurance of knee and hip prostheses

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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...

German Orthopaedists demand expertise for implant register (german)

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German state implant registry will not go active before 2023

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Germany (MDR): Every third medical technology company fears for its existence.

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Germany: Specialty association certifies cochlear implant centers

According to the professional association, around 50,000 people in Germany are deaf, and another 250,000 have at least a 50 percent hearing impairment. If sufficient understanding of speech is not possible with a hearing aid, a CI can restore hearing and understanding in many cases. A CI is not an...

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...

Guided bone regeneration of bone defects using a TiO2 scaffold

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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...

Hackney man first to receive 3D-printed prosthetic eye

A hospital patient will become the first person in the world to have a 3D-printed prosthetic eye. It is hoped the eye will be more realistic than a traditional acrylic prosthetic eye. It will also cut the time it takes for patients to be fitted with their prosthetics in half,...

Hearing Impairment in Old Age – detection, treatment, and associated risks

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Hearing Lens developed

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Hearing with a Vestibular Implant

Posture, Gait, Quality of Life, and Hearing with a Vestibular Implant Bilateral vestibular hypofunction is associated with chronic disequilibrium, postural instability, and unsteady gait owing to failure of vestibular reflexes that stabilize the eyes, head, and body. A vestibular implant may be effective in alleviating symptoms. Six months and 1...

Heart pacemakers and defibrillators often not affected by electromagnetic fields in everyday life

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High-performance brain-to-text communication via handwriting

Brain–computer interfaces (BCIs) can restore communication to people who have lost the ability to move or speak. So far, a major focus of BCI research has been on restoring gross motor skills, such as reaching and grasping or point-and-click typing with a computer cursor. However, rapid sequences of highly dexterous...

Hip endoprostheses: Adiposity is an important risk factor for infections

High adiposity is a decisive risk factor for a periprosthetic infection after hip joint replacement. This is shown by data from the Endoprosthesis Registry Germany (EPRD) Patients with a body mass index below 30 have a risk of less than one percent of suffering an infection. For patients with a...

Hip replacement: virtual surgical training with haptic technology (Interview)

Surgeons have only limited options to practice surgical techniques before they enter the operating room. The implantation of an endoprosthesis requires extensive practical training since it necessitates strength and utmost precision. The "Dynamic HIPS" project develops a virtual reality hip implant simulator that provides realistic haptic feedback. The project has been running...

Hip Surgery in Older Adults: Spinal or General Anesthesia

The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied. We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years...

Histological and Histomorphometrical Evaluation of a New Implant Macrogeometry. A Sheep Study

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Horizontal ridge augmentation using autogenous block grafts and the guided bone regeneration technique with collagen membranes : a clinical study with 42 patients

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How does the SARS-CoV-2 pandemic (COVID-19) affect medical technology? (German original)

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How long do revised and multiply revised knee replacements last?

A retrospective observational study of the National Joint Registry Knee replacements are common and effective operations but patients that undergo this intervention are at risk of needing subsequent costly and often complex revision surgery with poorer outcomes than primary surgery. The treatment pathway over the life of the patient in...

How long does a hip replacement last?

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How To Prepare For An FDA Inspection

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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)...

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...

Identification card and codification of the chemical and morphological characteristics of 62 dental implant surfaces. Part 1: description of the Implant Surface Identification Standard (ISIS) codification system

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Identification card and codification of the chemical and morphological characteristics of 62 dental implant surfaces. Part 2: anodized and Titanium Plasma-Sprayed (TPS) surfaces (Group 1, metallurgy modification)

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Identification card and codification of the chemical and morphological characteristics of 62 dental implant surfaces. Part 3: sand-blasted/acid-etched (SLA type) and related surfaces (Group 2A, main subtractive process)

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Identification card and codification of the chemical and morphological characteristics of 62 dental implant surfaces. Part 4: Resorbable Blasting Media (RBM), Dual Acid-Etched (DAE), Subtractive Impregnated Micro/Nanotextured (SIMN) and related surfaces (Group 2B, other subtractive process)

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Identification card and codification of the chemical and morphological characteristics of 62 dental implant surfaces. Part 5: chemically coated surfaces (Group 3, coating) and implant collar surfaces (Group 4, collar)

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Impact of implant diameter and length on stress distribution in osseointegrated implants

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Impact of implant length and diameter on survival rates

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implant files

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implant files: what you should know about

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Implant-Register reached 500 Companies

November 1st, 2017, Implant-Register® (implantwiki®) listed the 500th company dealing with implants

Implant-supported restorative therapy in a Swedish population

Replacing missing teeth through implant-supported restorative therapy is a common treatment procedure. While high survival rates have been reported, complications affecting the implant and/or the implant- supported reconstructions may occur. Such biological or technical complications require additional investment in treatment. Out of a cohort of 596 subjects, the proportion of...

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...

Implantable fiber-optic sensing system

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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...

Implanted System for Orthostatic Hypotension in Multiple-System Atrophy

Orthostatic hypotension is a cardinal feature of multiple-system atrophy. The upright posture provokes syncopal episodes that prevent patients from standing and walking for more than brief periods. We implanted a system to restore regulation of blood pressure and enable a patient with multiple-system atrophy to stand and walk after having...

ImplantFiles: Frequently asked questions and resources for readers

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Implantological indications for the use of bone replacement materials (german guideline, dental)

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Implants: researchers lay foundation for next generation aortic grafts

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Implants: When technology makes sense – quite literally

Disease, injury, or a condition you were born with – reasons why some people must live without one or several of their five senses. Fortunately, there are many modern sensory aids that help replace one sense with another, which is especially the case when it comes to vision and hearing....

Implications Of COVID-19: EU MDR Implementation Update

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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 New-Onset Atrial Fibrillation After TAVI

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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...

Independent Patient advice Germany (UPD) sees signs of excessive use of dental implants for elderly

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India To Regulate All Medical Devices

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Infections Associated with Resterilized Pacemakers and Defibrillators

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Inferences and metaphoric comprehension in unilaterally implanted children with adequate formal oral language performance

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Inferior Vena Cava Filter Use / Mortality Rates in Older Adults With Acute Pulmonary Embolism

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Influence of hydrogel coatings on corrosion and fatigue of iron in simulated body fluid

Surface corrosion and fatigue studies of pure iron were performed in a modified simulated body fluid (m-SBF) electrolyte with and without applied agar films as a typical hydrogel film. The electrochemical corrosion rates were analysed using electrochemical impedance spectroscopy. The morphology and surface chemical composition of the samples after exposure...

Influence of institutional experience on results in hip and knee total arthroplasty

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Integrated Single-Cell Atlases Reveal an Oral SARS-CoV-2 Infection and Transmission Axis

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Intelligent implants to monitor and control bone healing

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Interventions for replacing missing teeth: different types of dental implants

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Intestinal plasters

Biocompatible hydrogel technology prevents leakage In future, a new patch could be used after intestinal surgery to prevent leakage into the abdominal cavity. In this video interview, Dr. Alexandre Anthis from ETH Zurich explains the advantages of the hydrogel patch, both from a medical and an economic point of view....

Intraocular lenses and the development of glistenings

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Is osteoporosis a risk factor for implant survival or failure?

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Johnson & Johnson ‘negligent’ in landmark vaginal mesh lawsuit

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Knee prostheses: Relationship between service quantity and quality

Extensive surgical experience in the area of unicondylar sled prosthesis of the knee reduces the risk of further interventions. This is the result of an analysis conducted by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). However, the only robust study provided data only on revision risk....

Lateral Ridge Augmentation Using Autogenous Block Grafts and Guided Bone Regeneration: A 10‐Year Prospective Case Series Study

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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

Leg length discrepancy—treatment indications and strategies

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Liability issues in the scandal about defective silicone breast implants in Germany

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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...

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...

Long-Term Outcomes of Tooth-Implant-Supported Rehabilitation of Periodontally Compromised and Treated Patients Refusing Bone Grafting Surgical Therapies

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Long-term Risk of Reoperation After Synthetic Mesh Midurethral Sling Surgery for Stress Urinary Incontinence.

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Low Hospital Volume Increases Revision Rate and Mortality Following Revision Total Hip Arthroplasty

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Machine Vision – The new navigation for spine surgery

Precise, extremely quick and accurate – a new kind of navigation device in the OR uses a highly-developed camera technology to guide the surgeon through difficult procedures – directly in the OR. Prof. Ulf Liljenqvist, Chief Medical Director of the Clinic for Spinal Surgery at the St. Franziskus Hospital Münster,...

Magnet-controlled bioelectronic implant could relieve pain

A team of Rice University engineers has introduced the first neural implant that can be both programmed and charged remotely with a magnetic field. The integrated microsystem, called MagNI (for magnetoelectric neural implant), incorporates magnetoelectric transducers. These allow the chip to harvest power from an alternating magnetic field outside the...

Manufacturer to be liable for damage caused by breast implants (USA)

In a test case about health damage caused by silicone breast implants in the USA, the jury has decided that the company Dow Chemical can be held liable. The company had not sufficiently tested the effects of the implants on the human body and had provided insufficient information to patients...

Marginal bone loss around dental implants with and without microthreads in the neck

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Medical Device Biocompatibility – Toxicological / Biological Safety Assessments

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Medical Device Manufacturing Using Automation And A Digital Factory

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Medical device that treats pain shocks, burns patients

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Medtronic launches InterStim neurostim leads in U.S.

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Membrane-Inducing “Masquelet” Technique for Massive Traumatic Diaphyseal Femur Bone Loss in a Pediatric Patient: A Case Report

Case: A 14-year-old boy sustained 22 cm of femur bone loss after a motor vehicle accident. The patient underwent treatment with the membrane-inducing "Masquelet" technique for management of the injury. The grafts incorporated to form new bone and fill-in the void. Conclusion: Although the Masquelet technique is thoroughly described in adult orthopaedic...

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)....

Mesh, graft, or standard repair for women having prolapse surgery

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Metal corrosion in modular connections between cone adapter (CoCr alloy) and shank (Ti alloy) in hip implant systems (german)

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Metal-Specific Biomaterial Accumulation in Human Peri-Implant Bone and Bone Marrow

Metallic implants are frequently used in medicine to support and replace degenerated tissues. Implant loosening due to particle exposure remains a major cause for revision arthroplasty. The exact role of metal debris in sterile peri-implant inflammation is controversial, as it remains unclear whether and how metals chemically alter and potentially...

Metal‐Specific Biomaterial Accumulation in Human Peri‐Implant Bone and Bone Marrow

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Metals Used in Medical Devices

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Microimplants should enable new therapies against common diseases

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Microimplants: electricity instead of pills (Interview)

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Modernizing FDA’s program for the safety and effectiveness of medical devices

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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...

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 100,000 heart surgeries in Germany in 2019

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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...

Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

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Motor driven heart valve implanted (University Mainz, Germany)

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Multicenter study evaluating the novel, tapered, conical connection implants: 1-year results.

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Multivascular networks within biocompatible hydrogels

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Nanoparticles activate the NLR pyrin domain containing 3 (Nlrp3) inflammasome and cause pulmonary inflammation

Nanoparticles are increasingly used in various fields, including biomedicine and electronics. One application utilizes the opacifying effect of nano-TiO2, which is frequently used as pigment in cosmetics. Although TiO2 is believed to be biologically inert, an emerging literature reports increased incidence of respiratory diseases in people exposed to TiO2. Thus,...

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....

Necessity of routine x-rays after osteosynthesis

Routine x-rays after the osteosynthesis of distal radius and ankle fractures - a prospective randomized controlled trial on the necessity of routine imaging CONCLUSION: In this study, routine postoperative radiographs after osteosynthesis of distal radius and ankle fractures did not improve patient care when standardized intraoperative radiographs were obtained. Author(s)...

Nerve stimulation with the help of implantable mini solar cells

An international research team has successfully developed and tested a concept in which nerves are stimulated with light pulses. The method provides considerable advantages for medicine and opens up a wide range of possible applications. The researchers see possible applications in severe brain injuries. Here, the stimulation of nerve cells...

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...

Neural decoding of spoken sentences

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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,...

Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria

Technology to restore the ability to communicate in paralyzed persons who cannot speak has the potential to improve autonomy and quality of life. An approach that decodes words and sentences directly from the cerebral cortical activity of such patients may represent an advancement over existing methods for assisted communication. In...

Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria

Technology to restore the ability to communicate in paralyzed persons who cannot speak has the potential to improve autonomy and quality of life. An approach that decodes words and sentences directly from the cerebral cortical activity of such patients may represent an advancement over existing methods for assisted communication. We...

New drug to regenerate lost teeth

Tooth loss is a widespread problem in adults and results in poor quality of life. Currently, solutions to this problem include artificial teeth and implants. But these aren’t as good as “real teeth,” and they don’t markedly improve quality of life. Now, scientists from Japan have made a discovery that...

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...

New technology avoids complications during catheter replacement of mitral valve

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NEWS IN IMPLANTOLOGY

News
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Novel brain pacemaker first used for the treatment of obsessive-compulsive disorder (OCD)

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Number of cosmetic surgeries on the rise (Germany)

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Objective classification of glistenings in IOL

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On Implant-Registries: Implant registries represent an additional benefit for the patient

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organ donor card

Find an organ donor card in 29 languages here

Organs derived from donor pluripotent stem cells using a xenogenic environment

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Organs in miniature format

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Organs in miniature format

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Orthopedic implant: More comfortable thanks to full weight-bearing capacity

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Osseointegration of zirconia dental implants in animal investigations: A systematic review and meta-analysis

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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...

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...

Overcoming Addiction for the Sensory Impaired

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Pacemaker hack may put malware directly on the device

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Parameter-Specific Morphing Reveals Contributions of Timbre to the Perception of Vocal Emotions in Cochlear Implant Users

Research on cochlear implants (CIs) has focused on speech comprehension, with little research on perception of vocal emotions. We compared emotion perception in CI users and normal-hearing (NH) individuals, using parameter-specific voice morphing. Results:  Unsurprisingly, CI users as a group showed lower performance in vocal emotion perception overall. Importantly, while...

Paris court awards compensation to women for faulty breast implants

For years, the now insolvent manufacturer PIP had produced implants that were susceptible to rupture. The testing organization TÜV Rheinland had certified the process. A French court has now granted compensation to the complainants. The Paris Court of Appeal on Thursday condemned the testing organization TÜV Rheinland for lack of...

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...

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 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...

Patients and physicians see the benefits of cardiac catheter treatment differently. Patients overestimate it.

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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...

Paving the Way for Electronic Organs-on-a-Chip

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Perfectly fitting knee joints from the 3-D printer

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Performance of Bioprosthetic Aortic Valves

Comparison of Long-term Performance of Bioprosthetic Aortic Valves in Sweden From 2003 to 2018 Importance  The performance of bioprosthetic aortic valves is usually assessed in single valve models or head-to-head comparisons. National databases or registries offer the opportunity to investigate all available valve models in the population and allows for a...

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...

Permanent implantable cardiac support systems

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Phrenic nerve stimulation for the treatment of central sleep apnea

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PIP Poly Implant Prosthesis: German supreme court announces decision for 27.02.2020

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Platform for testing, development and approval of cardiovascular implants planned

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Poietis Automates the Manufacturing of Biological Tissue

While the manufacturing of biological tissue meets major societal demands, it also faces significant challenges related to process standardization and scaling up. With these challenges in mind, the French start-up Poietis has developed the Next Generation Bioprinting (NGB) platform to achieve 4D bioprinting of biological tissue in a faster, more affordable and more functional...

Polymeric Materials And Coronary Angioplasty Devices

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year.1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, resulting in heart attacks (myocardial infarction) and often death. Percutaneous transluminal coronary angioplasty (PTCA), a minimally invasive endovascular procedure...

Positive interim result for aftercare app for heart transplantation

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Possible causation between breast implants and the development of anaplastic large cell lymphoma (ALCL) / GERMANY (Update 14.11.2019)

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Postoperative after breast surgery

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Postoperative management of weight bearing and rehabilitation after lumbar spinal surgery

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Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement

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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...

Proton Pump Inhibitors and the Risk of Osseointegrated Dental Implant Failure

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Randomized clinical trial evaluating the effect of splinting crowns on short implants in the mandible 3 years after loading

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Recall of certain breast implants and tissue expanders from market

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Recall of textured Allergan Natrelle BIOCELL and McGhan implants and tissue expanders (2018)

BfArM, FDA: "Based on currently available information, including newly submitted data, our analysis shows that the risk of BIA-ALCL with textured Allergan Biocell implants is approximately six times higher than the risk of BIA-ALCL with textured implants from other manufacturers, and continued distribution of Allergan Biocell textured breast implants would...

Reduction of biofilm formation on titanium surface with ultraviolet-C pre-irradiation

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Regeneration therapy for lost teeth

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Regenerative heart valves: from simulation to replacement

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Registries of implantable medical devices in Europe

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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...

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...

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...

Removal Rates of Dental Implants Placed in Conjunction With Autologous Bone and Xenogeneic and Synthetic Alloplastic Materials in Finland Between 1994 and 2012

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Research network in Hanover conducts research on intelligent implants

Researchers from a wide range of disciplines will work together to develop intelligent implant systems for the dental, skeletal and hearing areas, which for the first time will allow continuous monitoring of implant function and thus early detection of complications such as infections. Intelligent implant systems are to be developed...

Resorbable vascular wall stent in development

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Restorative Neurostimulation to Activate the Lumbar Multifidus

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Results for the Ischemia Trials: To Intervene or Not to Intervene

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Retina chip implanted

A team led by Frank Holz, director of the Department of Ophthalmology at Bonn University Hospital (UKB), has implanted a retinal chip in a patient with advanced dry age-related macular degeneration (AMD) to preserve his vision. AMD is a visual disorder that increases with age and is characterized by progressive...

Ridge Augmentation Comparing an Allograft Plus Autogenous Bone Chips to an Osteoinductive Demineralized Bone Matrix

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Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents

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Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery

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Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg (Systematic Review/Meta‐Analysis)

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Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems (FDA)

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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...

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

SARS-CoV-2: CO2 traffic signals can be used as an orientation guide for good or bad ventilation.

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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...

Scientific investigation of sterile packaged medical devices (german original)

100 originally packaged dental implants were examined for residues using a scanning electron microscope.  The following materials were found: Metallic particles with significant amounts of copper, tin, chromium, iron, tungsten and nickel. Filmic residues and carbon containing particles. Chemicals such as erucamide, dodecylbenzene sulfonic acid. The author discusses the medical...

Self-charging pacemaker

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Self-healing capacity of fiber-reinforced calcium phosphate cements

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Serotonin and the Risk of Osseointegrated Implant Failure

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Serotonin Inhibitors and Risk of Dental Implant Failure

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Sights on implantable ‘living pharmacy’

Five Rice University engineering laboratories are part of a $33 million national effort to develop a wireless, fully implantable device that can control the body’s circadian clock, halving the time it takes to recover from jet lag and similar disruptions to the body’s sleep/wake cycles. Led by Northwestern University and...

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...

smartphones may affect implanted pacemakers

Current smartphones may affect the function of implanted pacemakers/defibrillators. The hypothesis: Compared to previous devices, newer smartphones have more centrally and circularly installed magnets. These allow fast wireless charging of the smartphone. This could impair the functioning of pacemakers and defibrillators more than before. The researchers found influences of the...

Soft occluder for the left atrial appendage

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Soft Robotics: Fluid‐Driven Intrinsically Soft Devices

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Soft tissue expansion before vertical ridge augmentation: Inflatable silicone balloons or self-filling osmotic tissue expanders?

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