A Medical Device Daily

CryoLife (Kennesaw, Georgia) reported FDA 510(k) clearance for its ProPatch Soft Tissue Repair Matrix, a product developed from bovine pericardial tissue used to reinforce weakened soft tissues and providing a resorbable scaffold that is replaced by the patient’s own soft tissue.

Steven Anderson, president/CEO of CryoLife, said, “The indications for its use are broad and varied, particularly for hernia repairs in which the use of a natural tissue product ... is preferred.”

ProPatch also is indicated for reinforcement of soft tissues, including muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. It also can be used to reinforce tissues repaired by sutures or by suture anchors during tendon repair surgeries, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons, according to the company.

In 2005, soft tissue repair was a $600 million market in the U.S., anticipated to grow 14% annually until 2010, according to a 2006 report by Millennium Research Group. Millennium estimates that by 2010, the U.S. ventral hernia market alone will approach $350 million with procedures nearing the 300,000 mark annually.

CryoLife processes implantable living human tissues for use in cardiovascular, vascular, and orthopedic surgeries throughout the U.S. and Canada.