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The PEEK-OPTIMA family of implantable polymers is formulated to meet exacting in-vivo criteria. Stringent physical, chemical, and mechanical testing takes place at key stages of the production process. This helps ensure the material will meet rigorous performance criteria as needed in heart valves — a typical human valve opens and closes 40 million times yearly.
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AorTech International plc, a Scottish-based developer and manufacturer of cardiovascular devices, uses a polyaromatic, semicrystalline polymer called PEEK-OPTIMA for the frame of its next-generation synthetic tri-leaflet heart valve. The valves are currently undergoing clinical trials in the U.S. and Europe and are expected to be on the market as early as 2005.
The AorTech valves are said to represent a major breakthrough in the replacement of damaged and diseased heart valves. They are designed to overcome the clinical problems associated with both mechanical and bioprosthetic (tissue) valves — mechanical valves force patients to undergo daily anticoagulant treatment while bioprosthetic valves have a limited life span.
According to AorTech's Chief Executive Eddie McDaid, "PEEK-OPTIMA was chosen for the valves because it is a highly reliable implantable material with a tailor-made combination of superior biocompatibility and long-term tribological and mechanical properties."
PEEK-OPTIMA polymer from Invibio Inc., Greensville, S.C., has undergone extensive biocompatibility and biostability testing to ensure suitability for implantation. It is supported by FDA Device Master Files, EEC Directive 90/128/EEC, ISO 10993 biocompatibility, USP Class VI compliance, and long-term implantation studies. Test results, including ISO 10993 and USP Class VI, are contained in detailed Master Files at the FDA.
