All Primary Implantable Product Lines Referenced In Customer FDA 510(k) Clearances
Evonik Corporation said today 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).
Evonik will be exhibiting at the American Academy of Orthopedic Surgeons (AAOS) Conference in New Orleans, La, on March 12-14, 2014, and can be visited at booth #1350.
To learn more about Evonik’s VESTAKEEP® PEEK product lines, please visit our website:
For additional information about Evonik in North America, please visit our website: www.evonik.com/north-america. Please visit us on Facebook at www.facebook.com/EvonikNorthAmerica. Follow us on Twitter at http://twitter.com/EvonikN_America.
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.
Evonik is active in over 100 countries around the world. In fiscal 2012 more than 33,000 employees generated sales of around €13.4 billion and an operating profit (adjusted EBITDA) of about €2.4 billion (excluding Real Estate in both cases).
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.