Invibio™ PEEK-OPTIMA® polymer selected for next generation heart valve frame

AorTech International plc, a leading Scottish-based developer and manufacturer of cardio-vascular devices, has concluded a long-term supply agreement with Invibio Ltd, for the supply of PEEK-OPTIMA® polymer. The polyaromatic, semi-crystalline polymer has been specified for the frame of the company’s next generation synthetic tri-leaflet heart valve.

The valve is currently undergoing stringent testing on both sides of the Atlantic, and in-vivo trials have commenced in Minneapolis, USA. AorTech hopes to secure approval in Europe by 2005 and in the USA by 2007, followed by full commercialisation shortly afterwards. Eddie McDaid, Chief Executive of AorTech, explains: “Concluding this long-term supply agreement with Invibio guarantees us continuity of supply of PEEK-OPTIMA, both throughout exhaustive clinical trials and into manufacturing. This agreement continues our successful working relationship with Invibio and our commitment to PEEK-OPTIMA polymer”.

“In the past, design has tended to move ahead of material technology in heart valves”, continues John McKenna, AorTech’s Marketing Manager. “Product designs using plastics date back to the 1950s. However, the polymers at that time did not provide the necessary durability. A typical human valve opens and closes 40 million times per year, which places critical demands on materials for synthetic valves”.

The first tilting disc designs in the 1960s used polyacetal and this is still found in some of the same valve markets that AorTech is targeting. Mr. McKenna continues: “POM offers good fatigue resistance and is totally non-reactive.

However, it does not deliver the necessary creep resistance. PEEK-OPTIMA polymer is a highly reliable implantable material with a tailor-made combination of superior biocompatibility and long-term tribological and mechanical properties”.

Michael Callahan, Managing Director of Invibio Ltd commented: " PEEK-OPTIMA is ideally suited for long-term in-vivo medical implants in cardiovascular, orthopaedic, and dental applications, and Invibio is pleased to provide PEEK-OPTIMA for use in this exciting project and to have our material specified as part of AorTech's next generation heart valve. With AorTech now planning for clinical trials in patients we are happy to have concluded a supply arrangement which will allow for the full commercialisation of the new heart valve."

AorTech’s state-of-the-art valve represents a major breakthrough in the replacement of damaged and diseased heart valves. It aims to overcome the current clinical problems of mechanical and bioprosthetic (tissue) valves. Patients with mechanical valves require daily anticoagulant treatment, while bioprosthetic valves have a limited lifespan.

Each valve needs to be matched to meet different tolerances and machined to deliver precise qualities to meet the need for extreme durability. AorTech has designed its own testing equipment, which enables it to monitor valve performance at different heart rates, blood temperature and pressures.

Invibio formulates its PEEK-OPTIMA family of implantable polymers to meet the most exacting in-vivo criteria. Stringent physical, chemical and mechanical testing is carried out at key stages of the production process. The result is a highly reliable implantable material that is designed to meet the most rigorous performance criteria.

In view of the traditionally long development period for a new implant, Invibio offers implant manufacturers additional security through a long-term "no-change agreement”. This guarantees the specification of PEEK-OPTIMA polymer over a given period of time as agreed with the customer.

PEEK-OPTIMA has undergone extensive biocompatibility and biostability testing to assure its suitability for implantation. The polymer is supported by FDA Device Master File (MAF) and the Drug Master File (DMF), EEC Directive 90/128/EEC, ISO 10993 biocompatibility and 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

Reader enquiries

Invibio Ltd
Technology Centre
Hillhouse International
Thornton Cleveleys
Lancashire FY5 4QD
United Kingdom
+44 1253 866812
info@​invibio.com
www.invibio.com

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Notes for editors

About Invibio:

Invibio™ provides biomaterial solutions for the implantable medical device market. PEEK-OPTIMA polymer is produced at its headquarters and manufacturing facility in Thornton Cleveleys, in the United Kingdom. With offices also in the USA and Europe, it is the sole worldwide manufacturer and distributor of PEEK-OPTIMA polymer, an advanced biomaterial suitable for long-term implantation.

For more information on the properties and performance advantages of PEEK-OPTIMA polymer, please call +44 (0) 1253 866812 or visit the company’s website at www.invibio.com.

Invibio Ltd is a wholly owned subsidiary of Victrex plc.