NEWS

2 million joint replacement surgeries recorded in the german endoprosthesis register

2021 ESC Guidelines on cardiovascular disease prevention in clinical practice

3-D printing market grows by 25 percent annually

3D bioprinting rebuilding components of the human heart

3D blood vessel printing (research)

3D eye cells printed for the first time

3D printing enters brave new world

3D printing for hearing devices

3D Printing of Heart

3D printing of soft robotic systems

3D Printing Plasma Jetting Method for Bone Implants

3D printing rapidly developing in life sciences

3D printing technologies for soft and hard tissue regeneration

3D printing technology could save animal testing

3D printing to aid tissue replacement

3d-printed Bone

3D-printed titanium mesh implants

A growth-accommodating implant for paediatric applications

A Road Map To China’s Medical Device Registration Process

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

Active Surveillance of Medical-Device Safety

Adverse events of reoperation after elective shoulder replacement

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

AI robot may help heal bones

Alloplastic substitution of the temporomandibular joint (german)

An 11- to 15-year clinical outcome study of a total knee arthroplasty

An enzymatic pathway that converts A to universal O type blood

Anaplastic large cell lymphoma from breast implants

Annual report 2019 of the Endoprostheses Register Germany (EPRD)

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

Antibacterial Envelope of Cardiac Implantable Device

Antihypertensive Medications and the Survival Rate of Osseointegrated Dental Implants

Aortic valve replacement –
TAVI and sAVR in comparison

Artificial intelligence supports the production of facial implants

Auditory brainstem implants – hearing restoration in congenitally deaf children

Auricular prostheses attached to osseointegrated implants

Autonomous robotic intracardiac catheter navigation

Avoid Compliance & Timeline Risks Whith Medical Device Supplier

Axial alignment is a critical regulator of knee osteoarthritis

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

Beinlängendifferenz – Therapieindikationen und -strategien

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

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

BIOCOMPATIBILITY OF PLASTICS

Biocompatible mini energy storage device for direct diagnosis in the body

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

Bioink for Printing 3D Cardiac Constructs

Bioinspired Heart Valve Prosthesis (Silicone, Additive Manufacturing)

Biomaterials Market – Global Forecast to 2020

Biomimetic 3D-printed scaffolds for spinal injury repair

Bionic eyes are now obsolete and unsupported

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

Bioprinting- 3D printing of lung scaffolds

Bioprinting: Where do your bones come from?

Bioresorbable Scaffolds versus Metallic Stents in Routine PCI

Biphosphonates affect Dental Implants

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

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

Bone tissue engeneering via ultrasound-mediated gene delivery

Brain implant enables ALS patients to communicate with the world outside

Breast implant tourism in Tunesia

Breast implants may falsify EKG (german)

Breast Implants: Update – Associated Anaplastic Large Cell Lymphoma

C. R. BARD discontinues selling vaginal mesh products globally

Call-back of pacemakers

Canada acts on Implant Files

CANADA: Medical Device Single Audit Program Transition Plan

Cardiopatch for heart tissue

Cemented or Uncemented Hemiarthroplasty for Intracapsular Hip Fracture

Cemented or Uncemented Hemiarthroplasty for Intracapsular Hip Fracture

Challenges To The Orthopedic Biomaterials Market In 2019

Changes of clinically failed SLA implants after in vitro debridement

Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers

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

China Regulation of Medical Devices

Claims for faulty breast implants against French insurance fails in Germany

Clinical approach of ceramic dental implants

Clinical Evaluation Reports under the EU MDR

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

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

Cochlear implantation – diagnosis, indications, and auditory rehabilitation results

Cochlear optogenetics – spectral selectivity

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

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

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

Complete Revascularization with Multivessel PCI for Myocardial Infarction

Compliance with legal requirement to report clinical trial results on ClinicalTrials

Complications with an implantable insulin pump

Concerns about paclitaxel-coated stents and balloons removed

Consent for chip implants in the population increases

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

Converting blood type A donor lungs into universal blood type lungs

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

Court orders TÜV to pay damages in breast implant scandal

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

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

Criminals fake implants with 3-D-tools

Current Standard in Shoulder Replacement (2003)

Custom made subperiosteal oral implant enables to place definite fixed prosthesis in 6 weeks (german)

Custom-made silicone heart valves

Custom-milled individual allogeneic bone grafts for alveolar cleft osteoplasty – A technical note

Dangerous information deficit on implants (implant files, german)

Dassault Systèmes’ Living Heart Project Reaches Next Milestones

Deaf children learn words faster than hearing children

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

Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

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

Dental companies to make changes to their product range

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

Dental implant prosthetic rehabilitation of a patient with epidermolysis bullosa dystrophica

Dental Implant Software – List

Dental Implants in Times of Coronavirus

Dentalpoint announces partnership with Nobel Biocare Services AG

Depression, Antidepressants, and Bone Health in Older Adults

DePuy ASR™ Hip Recall Guide

Deutsches Implantateregister soll 2023 in Betrieb gehen (german text)

Diagnosing peri-implant disease using the tongue

Digital Health Innovation Plan (FDA)

Digital light 3D printing of customized bioresorbable airway stents

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

Drug-coated balloons for small coronary artery disease

Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

Drug-eluting stents (DES) superior versus bare-metal stents

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

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

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

Efficacy and Safety of an Extravascular, substernally implanted Cardioverter–Defibrillator

Efficacy and Safety of Vertebral Augmentation

Efficacy of restorative brain–computer interfaces

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

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

Endoprosthesis Register (Germany) shows reasons for early replacements

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

Endoprosthetics: Active role of the patient required

ESC/EACTS Guidelines for the management of valvular heart disease 2017

Esophageal Organoids from Human Pluripotent Stem Cells

EU CED: Implant certificate for dental implants (passport)

EU CED: Implantatpass für Zahnimplantate

EU intends to postpone medical devices regulation by one year

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

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

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

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

Eudamed database: Registration as economic operator possible from 01.12.20

Europe: Authorities judge cancer danger at breast implants differently

Europe: Dental companies to make changes to their product range

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

European Commission names UDI Issuing Agencies

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

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

Examining FDA’s New Patient Labeling Draft Guidance

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

FDA challenged over metal implants ‘public health travesty’

FDA stops sales of urogynecologic surgical mesh implants

FDA: Known risk of lymphoma from breast implants

FDA: Reporting Allegations of Regulatory Misconduct

FDA: Unique Device Identification

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

First 3D printed lower jaw implant in China

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

Foramen Ovale Closure after Stroke

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

Fully implantable and bioresorbable cardiac pacemakers without leads or batteries

Fully implantable cochlear implant placed

GDPR and Medical Devices

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

Genetically Modified Porcine-to-Human Cardiac Xenotransplantation

Genium knee joint – insurance (german)

Gentamicin coating of titanium alloy prevents implant-related osteomyelitis in rats

German government decides on a national implant patient registry

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

German Ministry of Health announces national Implant-Register

German Orthopaedists demand expertise for implant register (german)

German state implant registry will not go active before 2023

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

Germany: Health insurance fund does not have to pay for breast augmentation for psychological reasons

Germany: Specialty association certifies cochlear implant centers

Green light for transplant registry in Germany

Growth-accomodating implant for paediatric applications

Guided bone regeneration of bone defects using a TiO2 scaffold

Hacking risk leads to recall of 500,000 pacemakers

Hackney man first to receive 3D-printed prosthetic eye

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

Hearing Lens developed

Hearing with a Vestibular Implant

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

Heart Transplant and Artificial Heart Systems

Heart valves that can grow with pediatric patients

High-performance brain-to-text communication via handwriting

Hip endoprostheses: Adiposity is an important risk factor for infections

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

Hip Surgery in Older Adults: Spinal or General Anesthesia

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

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

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

How long do revised and multiply revised knee replacements last?

How long does a hip replacement last?

How To Prepare For An FDA Inspection

Hydrophilicity, Viscoelastic, and Physicochemical Properties Variations in Dental Bone Grafting Substitutes

Hyperelastic “bone”

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

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)

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)

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)

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)

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

Impact of implant length and diameter on survival rates

implant files

implant files: what you should know about

Implant-Register reached 500 Companies

Implant-supported restorative therapy in a Swedish population

Implantable Artificial Kidney Could Enter Human Trials By 2017

Implantable cooler to temporarily block nerve conduction and ease pain

Implantable fiber-optic sensing system

Implantable Silicone

Implanted System for Orthostatic Hypotension in Multiple-System Atrophy

ImplantFiles: Frequently asked questions and resources for readers

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

Implants: researchers lay foundation for next generation aortic grafts

Implants: When technology makes sense – quite literally

Implications Of COVID-19: EU MDR Implementation Update

In laboratory breeded bone implanted

Incidence of New-Onset Atrial Fibrillation After TAVI

Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population

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

India To Regulate All Medical Devices

Infections Associated with Resterilized Pacemakers and Defibrillators

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

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

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

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

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

Intelligent implants to monitor and control bone healing

Interventions for replacing missing teeth: different types of dental implants

Intestinal plasters

Intraocular lenses and the development of glistenings

Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty

Is osteoporosis a risk factor for implant survival or failure?

Johnson & Johnson ‘negligent’ in landmark vaginal mesh lawsuit

Knee prostheses: Relationship between service quantity and quality

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

Leadless pacing of hearts

Leg length discrepancy—treatment indications and strategies

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

Long-Term Cancer Risk Among Swedish Women With Cosmetic Breast Implants: An Update of a Nationwide Study

Long-Term Evaluation of ANKYLOS® Dental Implants

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

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

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

Machine Vision – The new navigation for spine surgery

Magnet-controlled bioelectronic implant could relieve pain

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

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

Medical Device Biocompatibility – Toxicological / Biological Safety Assessments

Medical Device Manufacturing Using Automation And A Digital Factory

Medical device that treats pain shocks, burns patients

Medtronic launches InterStim neurostim leads in U.S.

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

Mesh versus suture repair of umbilical hernia in adults

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

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

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

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

Metals Used in Medical Devices

Microimplants should enable new therapies against common diseases

Microimplants: electricity instead of pills (Interview)

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

More complications in heart valve surgery in the morning

More Plastic Surgery worldwide in 2015

More pragmatic randomized studies with a focus on registry-based trials

More than 100,000 heart surgeries in Germany in 2019

More than 14.000 cases reported as problems with implants in Germany 2017

Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

Motor driven heart valve implanted (University Mainz, Germany)

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

Multivascular networks within biocompatible hydrogels

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

Nasal chondrocyte-based engineered autologous cartilage tissue

Necessity of routine x-rays after osteosynthesis

Nerve stimulation with the help of implantable mini solar cells

Neural Bypass Technology

Neural decoding of spoken sentences

Neuromodulation of lumbosacral spinal networks after complete paraplegia

Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria

Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria

Neurostimulation with Laryngeal Pacemaker Does Not Affect Vocal Quality

New drug to regenerate lost teeth

New pacemaker without battery

New technology avoids complications during catheter replacement of mitral valve

NEWS IN IMPLANTOLOGY

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

Number of cosmetic surgeries on the rise (Germany)

Objective classification of glistenings in IOL

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

Optogenetic cochlear implant to improve hearing

organ donor card

Organs derived from donor pluripotent stem cells using a xenogenic environment

Organs in miniature format

Organs in miniature format

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

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

Osteogain® loaded onto an absorbable collagen sponge

Outcomes for Absorb Stent Acceptable at One to Two Years, with Caveats

Overcoming Addiction for the Sensory Impaired

Pacemaker For Larynx Allows Patients To Breathe Easier

Pacemaker hack may put malware directly on the device

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

Paris court awards compensation to women for faulty breast implants

Parkinson’s disease: Better overall behavioural outcomes with bilateral subthalamic stimulation plus medical therapy

Patient Dissatisfaction Following Total Knee Arthroplasty

Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature

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

Patients of faulty hip implants can seek damages

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

Perfectly fitting knee joints from the 3-D printer

Performance of Bioprosthetic Aortic Valves

Peri-implant tissue conditions in implants placed with simultaneous augmentation procedure

Permanent implantable cardiac support systems

Phrenic nerve stimulation for the treatment of central sleep apnea

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

Platform for testing, development and approval of cardiovascular implants planned

Poietis Automates the Manufacturing of Biological Tissue

Polymeric Materials And Coronary Angioplasty Devices

Positive interim result for aftercare app for heart transplantation

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

Postoperative after breast surgery

Postoperative management of weight bearing and rehabilitation after lumbar spinal surgery

Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement

Proprioception from a neurally controlled lower-extremity prosthesis

Proton Pump Inhibitors and the Risk of Osseointegrated Dental Implant Failure

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

Recall of certain breast implants and tissue expanders from market

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

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

Regeneration therapy for lost teeth

Regenerative heart valves: from simulation to replacement

Registries of implantable medical devices in Europe

Regulation on Medical Devices Europe (MDR) causes unrest

Release of chlorhexidine from titanium dental implant

Reliability In Medical Electronic Devices

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

Research network in Hanover conducts research on intelligent implants

Resorbable vascular wall stent in development

Restorative Neurostimulation to Activate the Lumbar Multifidus

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

Retina chip implanted

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

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

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

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