PEEK-OPTIMA^®LT polymer is the material of choice for orthopaedic implants

Invibio™ PEEK-OPTIMA^® LT polymer has replaced POM-C in the manufacture of Synthes® spiked washers. These FDA cleared ligament fixation device has been developed by Mathys Medical Ltd for use in traumatology for ligament reattachment or fixation specifically for readaptation of torn or avulsed ligaments.

This unique polyaryletherketone polymer, which has been specially developed by Invibio Ltd for long-term implants, combines extensive biocompatibility testing and purity with long-lasting mechanical strength and chemical resistance.

Michael Callahan, Managing Director of Invibio™ explains: "Sterilization resistance was a key material requirement in this application. Compared with POM-C, PEEK-OPTIMA^® LT polymer is characterized by extreme hydrolytic resistance, even at elevated temperatures, ionizing radiation resistance and superior mechanical strength. This means that the washers can withstand sterilization by steam, gamma radiation and ethylene oxide processes without loss of strength, stiffness or toughness”.

Mathys Medical Ltd, with headquarters in Bettlach, Switzerland, is part of the Mathys Medical Group of companies. With 19 subsidiaries worldwide, the Group is ranked among the world’s leading companies in the areas of operative fracture treatment, spine- and maxillofacial surgery. Mathys sells Synthes® products in many parts of Europe and in all countries of Asia, Africa, Australia/Pacific and in the Middle East. The Group has 1,800 employees worldwide.

Invibio™ has performed extensive biocompatibility and biostability testing on

PEEK-OPTIMA^® LT polymer. These results, including ISO 10993 and USP Class VI, are contained in detailed Master Files at FDA. These include Device Master Files (MAF) and Drug Master Files (DMF).

A further important benefit of PEEK-OPTIMA^® LT polymer is its ideal imaging properties. It is inherently radiolucent and can be easily modified to be radiopaque, thereby enabling patients with a PEEK-OPTIMA^® LT polymer implant to be readily monitored by X-ray, CT or MRI scanning.

Invibio™ provides biomaterial solutions for the implantable medical device market.

Reader enquiries

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

---

Notes for editors

PEEK-OPTIMA^® polymer is produced at its headquarters and manufacturing facility 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.