EUDAMED

May 22, 2023

EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED is integral part of the implementation of the two Medical Devices Regulations.

source: European Commission

Latest News

Rehabilitation after leg amputation with transcutaneous osseointegrated prostheses

September 27, 2023Traditional prostheses after limb amputations allow only a part of the affected persons to achieve the desired and desired autonomous mobility. In analogy to dental implants, systems have been developed that allow the coupling of an exoprosthesis to a force carrier integrated in the bone and transmitted through the skin. Almost all of the problems associated with prosthetic limb replacement are due less to the functionality of the artificial joints and more to the prosthesis fixation systems that surround the residual limb. Therefore, starting in the 1990s, a concept analogous to dental implants was developed for limb replacement: A load bearing device permanently fixed in the bone and transmitted transcutaneously serves to couple the prosthesis.Such transcutaneous osseointegrated prosthesis systems (TOPS) represent a paradigm shift in care after limb amputation. They have become an indispensable part of the rehabilitation options, both in view of the high mobility gain and the significantly improved patient satisfaction. After initially proceeding in two stages and applying the stoma 4-6 weeks after insertion of the force carrier, the one-stage procedure has now proven successful. Depending on the bone quality of the soft tissue situation and the patient’s sensation, docking of the exoprosthesis by the orthopedic technician and subsequent mobilization can begin 3-6 weeks later. The interface between the endomodule and the exomodule is located between the conical sleeve and the knee connection adapter, which is firmly attached to the exoprosthesis and can be fixed or loosened by the patient with one hand. The knee joints are regularly equipped with microprocessors for control, as this minimizes the risk of falls. Between January 2003 and December 2021, the authors treated 244 patients (151 m/71 w) with a median age of 47.6 years (17-95 years), some bilaterally; long-term outcome data are available from 232 patients. To date, 13 femoral implants have been removed due to intramedullary infection, implant fatigue failure (after 7-14 years), chronic soft tissue problems, and patient request. TOPS reimplantation was successful in 4 of these patients. Author(s) Source Aschoff HH, Saß M, Mittlmeier Th, Fischer D-C Dtsch Arztebl 2023; 120(38): A-1518 / B-1304 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

First drug to grow new teeth

September 24, 2023A team of scientists led by a Japanese pharmaceutical startup has been working on a drug to stimulate the growth of new teeth in what would be a world-first, aiming to put it on the market by around 2030. Does it make dental implants obsolete? The team plans to hold a clinical trial for the drug from 2025 for children between 2 and 6 years old with anodontia, who are born without some or all permanent teeth. The children will be injected with one dose to induce teeth growth. There are also hopes to utilize the drug in the future for adults who have lost teeth due to cavities. “Missing teeth in a child can affect the development of their jaw bone,” said Katsu Takahashi, co-founder of Toregem Biopharma and head of dentistry and oral surgery at Kitano Hospital in Osaka. “We hope the drug will serve as a key to solving those problems,” he said. Author(s) Source Kyodo the Japan Times Sep 24, 2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

Second Historic Transplant of Pig Heart into Patient

September 22, 2023A 58-year-old patient with terminal heart disease became the second patient in the world to receive a successful transplant of a genetically-modified pig heart on September 20. He is recovering well and communicating with his loved ones. This new patient had end-stage heart disease. He was deemed ineligible for a traditional transplant with a human heart, by UMMC and several other leading transplant hospitals, due to his pre-existing peripheral vascular disease and complications with internal bleeding. This transplant was the only option available for this patient who was facing near-certain death from heart failure. Author(s) Source Deborah Kotz University of Maryland, Medical Center, Press release 22.09.2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

Detect Endoprosthesis loosening at an early stage

September 21, 2023Our society is aging. So the number of people who need an artificial hip joint, for example, is also rising. This can have long-term consequences for the healthcare system. “In more than ten percent of cases, loosening of the implanted prosthesis occurs within 15 years after hip surgery” (Alexander Franck, MD). The time of detection plays a decisive role in planning a new operation that may be necessary: the earlier loosening is detected, the lower the complications in the event of a prosthesis replacement. “The presence of mechanical loosening or loosening due to infection significantly influences treatment and prognosis.” Using measurement data, Jan Lützelberger’s team hopes to be able to make a statement about early loosening in the future using an ultrasound-based measurement method. In addition, the method offers, in principle, the possibility of detecting the formation of a bacterial film on the prosthesis. Author(s) Source Cindy Dötschel Coburg University, Press releas 21.09.2023 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

New Companies

Organon

September 28, 2023unregistered register now update records IMPLANTS U.S.A. product group subcutaneus implant products NEXPLANON® contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

MicroTransponder, Inc

September 27, 2023unregistered register now update records IMPLANTS U.S.A. product group nervous system implant products Vivistim® works within the brain to help the body during stroke rehab improves the brain’s ability to relearn motor tasks contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

Sparta Biomedical®

September 27, 2023unregistered register now update records IMPLANTS U.S.A. product group skeletal system implant products OrmiTM Galene bionic cartilage <preclinic phase> contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

New Implants

NEXPLANON®

September 28, 2023IMPLANT PROFILE unregistered register here update records radioopaque the implant X-ray 01 indication hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years 02 specific implant, for subdermal use only 03 contraindication(s) ◊◊◊◊◊ 04 implant description ◊◊◊◊◊ 05 specific attributes ◊◊◊◊◊ 06 material etonogestrel 07 implant surface n/a n/a 08 key literature ◊◊◊◊◊ 09 notes about the company n/a 10 approvals CE-Marking (?) FDA-Approval learn more about approvals, certifications, authorities No comments yet. You are welcome to send comments or experiences. HERE, if you received this implant. and HERE, if you placed this implant. Received this implant? You can register it HERE (fee). Placed this implant? You can register it HERE for your patient (fee). current as of 2023-09-25 unregistered / this page is not approved by the provider / unregistered implants have no professionnal lines or advertising This “Implant Profile” shows a non-registered implant. This is a most comprehensive description of the important parameters of an implant. Information given here are checked thoroughly by “Implant-Register” and is not approved by the manufacturer/the company. Illustrations refer to the company, if not shown differently. However we can not guarantee for any material or properties. Implants may not be available in all countries. If there are pictures like logos or implants, they are taken from the companies website. The publishing company may inform us to hide them. [...] Read more...

REFLECT™ Scoliosis Correction System

September 27, 2023IMPLANT PROFILE unregistered register here update records the implant in situ 01 indication minimally invasive implant system designed to correct progressive scoliosis in young patients 02 specific it preservs motion, maintains stability, and allows for future modulated growth 03 contraindication(s) ◊◊◊◊◊ 04 implant description ◊◊◊◊◊ 05 specific attributes ◊◊◊◊◊ 06 material titanium, coated with HA 07 implant surface n/a <picture> 08 key literature ◊◊◊◊◊ 09 notes about the company n/a 10 approvals CE-Marking FDA-Approval learn more about approvals, certifications, authorities No comments yet. You are welcome to send comments or experiences. HERE, if you received this implant. and HERE, if you placed this implant. Received this implant? You can register it HERE (fee). Placed this implant? You can register it HERE for your patient (fee). current as of 2022-08-25 unregistered / this page is not approved by the provider / unregistered implants have no professionnal lines or advertising This “Implant Profile” shows a non-registered implant. This is a most comprehensive description of the important parameters of an implant. Information given here are checked thoroughly by “Implant-Register” and is not approved by the manufacturer/the company. Illustrations refer to the company, if not shown differently. However we can not guarantee for any material or properties. Implants may not be available in all countries. If there are pictures like logos or implants, they are taken from the companies website. The publishing company may inform us to hide them. [...] Read more...

Sientra saline sizer

May 13, 2023saline sizers (discontinued) products round moderate plus projection smooth surface high projection smooth surface teardrop shape, classic base moderate plus projection smooth surface teardrop shape, round base high projection smooth surface [...] Read more...

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