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, it was announced by Craig Valentine, director of regulatory affairs for Invibio.
“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, said Valentine.
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, according to Valentine.
"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”.
Solvay Specialty Polymers has also reported a steady increase in use of its PEEK plastics in spine and other implant applications.
PEEK first replaced metal as a spinal implant in 1999.
A specially developed grade of high molecular weight polyethylene (at Massachusetts General Hospital, Boston) is widely used in knee and hip replacements. Some PEEK is also used in custom cranial implants. The next big plastic advance inside the human body will be use of bioresorbable plastics as coronary stents. Abbott is taking the lead with a polylactide-based plastic.