Evonik Corp. officials announce that each of its primary implantable VESTAKEEP PEEK product lines have been referenced in customer products that have received U.S. Food and Drug Administration's (FDA) 510(k) clearance for permanent implant use.
“We are excited about the growing interest VESTAKEEP PEEK is receiving within the medical device industry,” said Peter Colburn, director of Evonik's VESTAKEEP implant product lines. “It is clear that medical device manufacturers need innovative companies like Evonik to create materials and offer services meeting their specific needs. VESTAKEEP PEEK is known for its superior biocompatibility, biostability, and combination of stiffness and ductility, making it not only a unique polymer but also an excellent material for medical implant applications.”
The product lines used in medical devices that have received FDA 510(k) clearance include VESTAKEEP i2G Resin for injection molding applications, VESTAKEEP i4G Resin for injection molding and extrusion applications, and VESTAKEEP i4R Stock Shape for machined implant applications.
“We are building a global business around the needs of the marketplace,” said Sanjeev Taneja, global vice president of Evonik's VESTAKEEP product lines. “Momentum is building as we develop the next generation of PEEK product lines through Evonik's vast global research and development resources and network of the world's leading research institutions. Currently, we are developing numerous devices for cardiovascular, neuromodulation, sleep apnea and dental applications.”
Products using VESTAKEEP PEEK that have already received FDA 510(k) clearance cover a broad range of applications including spinal implants, suture anchors, cranial implants, pharmaceutical drug delivery devices and implantable MRI markers supporting image-guided cancer treatment procedures.
Colburn cites the VESTAKEEP PEEK Masterfile strength as a key contributing factor to the material's success within the medical device market. Several VESTAKEEP PEEK products are in development and planned for launch this year including VESTAKEEP PEEK with Barium Sulfate (BaSO4) and VESTAKEEP PEEK with Carbon Fiber (CFF).