Vestakeep PEEK polymer now used in more than 80 medical devices

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 industry’s 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.

“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, we’ll continue to develop the Vestakeep portfolio to grow our business and to advance PEEK polymer technologies for improving healthcare worldwide.”