A Medical Device Daily

Tepha (Lexington, Massachusetts), a developer of devices derived from a new class of polymers, reported that two of its corporate partners, Aesculap (St. Louis) and Tornier (Edina, Minnesota), are conducting initial clinical evaluations of the company's new TephaFlex suture products.

These clinical evaluations, conducted in both the U.S. and Europe, represent the first human usage of medical devices derived from Tepha's new class of resorbable polymers called polyhydroxyalkanoates (PHAs), the company said.

The Tepha PHA polymer family is a product of the company's recombinant DNA technology which allows the engineering of resorbable medical devices with mechanical and biologic properties that are matched to specific tissue repair and replacement applications. The company said that the TephaFlex monofilament suture is up to 30% stronger, more flexible, and has longer strength retention than currently marketed resorbable sutures.

Aesculap, a Tepha corporate partner since 2004, currently is conducting a European trial evaluating suture products based on TephaFlex fiber in 150 patients undergoing abdominal wall repair procedures. The results of this trial will be submitted to European regulatory authorities to support Aesculap's application for CE-mark approval.

Tornier, a Tepha corporate partner since 2007, recently supported the clinical evaluation of the TephaFlex Absorbable Suture by several U.S. orthopedic surgeons. The suture, FDA 510(k)-cleared in February 2007, was used in a range of orthopedic soft-tissue repair procedures.

Aesculap's product range includes sutures, implants for orthopedic and spinal surgery, surgical instruments, endoscopes, surgical motor systems, container and storage systems, and vascular therapy products.

Tornier develops products for the extremity orthopedics market.