Evonik Industries has revealed that each of its primary implantable VESTAKEEP® PEEK product lines have been referenced in customer products that have received US Food and Drug Administration (FDA) 510(k) clearance for permanent implant use.
Evonik’s VESTAKEEP® implant product lines director Peter Colburn said that VESTAKEEP PEEK’s masterfile strength is key to the material’s success within the medical device market.
"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," he added.
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.
Evonik global vice president of VESTAKEEP product lines Sanjeev Taneja said: "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.
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).