The medical device industry is much bigger than most people think, and it is continuing to grow. Did you know that plastic is an integral part of that industry? Many kinds of plastic are used in medical devices such as implants, prosthetic devices, surgical tools and much more. The article below specifically talks about polymer and the numerous uses for it in medical devices. Learn more below!
Evonik (Essen, Germany) announced that its Vestakeep PEEK material has reached a milestone. The polymer, which is used in the design and development of surgical implants, recently surpassed more than 80 devices cleared by FDA.
Medical OEMs usually take one of two paths to have their implantable devices reviewed and approved, or cleared, by FDA, explained Evonik. One is a Premarket Approval (PMA), which is the most stringent approval process, often requiring years of testing and clinical trials to prove the implant has sufficient safety and effectiveness for the intended use. The other is a Premarket Notification (510K), which typically takes 90 days or less and references a predicate FDA-approved device. Although Vestakeep PEEK has more than 80 customer devices cleared under the 510K process, it has also been used in devices approved under the more stringent PMA process.
Vestakeep was developed to address the medical device industrys need for high-performance biocompatible materials. Its high fatigue resistance and toughness has proven to be critical in the successful development of these devices that see high stress loads during surgical implantation and throughout the healing process, according to Evonik. Material applications include the orthopedic, spine, sports medicine, cardiovascular, extremities, cranio-maxillofacial, dental and oncology market segments.
Advances in medical design and manufacturing and plastics technology will be showcased in the MD&M and PLASTEC zones at the Advanced Design & Manufacturing (ADM) Cleveland event. The trade show and conference comes to the Huntington Convention Center in Cleveland on March 29 and 30. Go to the ADM Cleveland website to learn more about the event and to register to attend.
Achieving this milestone with our customers demonstrates the overwhelming acceptance and growth of Vestakeep in the medical marketplace, said Vikram Chatur, Vice President and General Manager for High Performance Polymers for Evonik. With our strengths in R&D and innovation, well continue to develop the Vestakeep portfolio to grow our business and to advance PEEK polymer technologies for improving healthcare worldwide.