Evonik’s Permanently Implantable VESTAKEEP® PEEK Material Gets FDA’s Thumbs Up

Evonik Corporation said today each of its primary implantable VESTAKEEP® PEEK product lines have been referenced in customer products that have received U.S. FDA 510(k) clearance for permanent implant use.

Background

German industrial company Evonik claims to be one of the world leaders in specialty chemicals and focuses its activities on the key megatrends of health, nutrition, resource efficiency and globalization.

The company’s VESTAKEEP® PEEK material is now found pretty much everywhere in medical device world, possessing as it does properties of biocompatibility, biostability, and an optimal combination of stiffness and ductility. This renders it an alternative to metal in a variety of applications including implants.

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.

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).

And yes, you guessed it…. you can visit Evonik at this week’s AAOS meeting in New Orleans.

Company comments

“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.”

“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.”

Source: Evonik Corporation, Business wire

 

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