Global Regulatory Milestones for Invibio Biomaterial Solutions in US and China

Invibio Biomaterial Solutions’ innovative PEEK-OPTIMA™ family of biomaterials – including the world’s first implantable grade polyetherketone (PEEK) polymer – have achieved considerable regional regulatory milestones, particularly significant in the current regulatory climate, it was announced today by Invibio director of Regulatory Affairs, Craig Valentine. As of February 2013, the number of implantable medical devices manufactured from PEEK-OPTIMA and cleared for market in the US reached 500, with more than 80 approved for market in China*.

“The regulatory environment globally is more challenging than ever. Support of data and knowledge through the process can help device companies overcome regulatory barriers. We are committed to continuing our investments in resources to support medical device companies’ regulatory submissions across global markets. Invibio maintains a Drug & Device Master file data at the US FDA and has specific test data required for both China and Japan available to customers on file. This data is utilized by the regulatory authorities and provides the verification of PEEK-OPTIMA’s biocompatibility and biostability, which is supported by a dedicated global regulatory team.” said Valentine.

Valentine noted “As medical device companies look for growth in BRIC countries, as evidenced by recent market acquisitions, knowledge and experience of the regulatory pathway is an advantage to speeding access to market”. The steady rise in the medical device industry’s use of PEEK-OPTIMA in spine as well as other applications is mirrored elsewhere around the globe as well with PEEK-OPTIMA based implantable medical devices approved in all the BRIC emerging markets.

In 1999 PEEK-OPTIMA became the first-ever biomaterial to replace the use of metal in spinal applications, when it was incorporated into an interbody fusion cage. Today, PEEK-OPTIMA interbody fusion devices are the standard of care in both lumbar and cervical fusion, and device manufacturers have selected PEEK-OPTIMA for use in other spinal applications including TDR (total disc replacement), spinal rods and interspinous devices.

“As demonstrated by these global regulatory milestones, PEEK-OPTIMA continues to set an industry standard for biomaterials biocompatibility and quality. Invibio’s commitment to advancing medical device design innovation does not stop at our biomaterial capabilities. Our strong strategic alliances within the research and surgical community and across the global medical device industry, combined with our depth and breadth of biomaterials, and manufacturing capabilities enable Invibio to partner with our customers to access and accelerate their time to market in a challenging environment,” said Valentine.

Since 1999, the versatile family of PEEK-OPTIMA polymers have steadily gained market acceptance. Today these market-leading biomaterials are extensively used in over four million medical devices worldwide. The applications span trauma (plates, nails and screws for example); arthroscopy (for anchors and interference screws); orthopedic (for structural components and finger, hip and knee components); cranial plates; dental; cardio, neurological and bariatrics.