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Zimmer launches biological patch for rotator cuff repair

The collagen patch resists collagenase activity and breakdown in the body and induces less inflammatory responses, the company said.

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WARSAW, Ind. — Zimmer Holdings Inc. has launched a new biological product for the surgical repair of rotator cuff injuries, the company announced.

The product, called the Zimmer Collagen Repair (ZCR) Patch, is a chemically crosslinked, acellular sheet of collagen/elastin derived from porcine dermis that is “highly resistant to breakdown by enzymes in the body,” according to a press release from Zimmer.

United Kingdom-based Tissue Science Laboratories PLC originally developed the underlying technology. Zimmer is marketing the patch in the United States under an exclusive multiyear distribution agreement signed by the two companies in 2003. Zimmer expects to have the patch available globally later this year.

The company believes that the ZCR Patch has several potential advantages over other current products or treatments. The patch has high resistance to collagenase activity and breakdown in the body, which promotes increased repair stability during the healing process. The technology also causes less of an inflammatory response, the company said. Additionally, the patch can be stored at room temperature rather than requiring refrigeration and does not require rehydration before use, the company noted.

Tissue Science Laboratories has been marketing a similar version of the product in the United Kingdom under the brand name Permacol. The FDA approved the ZCR Patch — known then as the Permacol patch — in November 2002 under a 510(k) application submitted by Tissue Science Laboratories. At the time, the FDA decided the product was “substantially equivalent” to other existing products, including DePuy’s Restore Orthobiologic Soft Tissue Implant, Organogenesis Inc.’s Fortaflex Surgical Mesh and Cook Biotech’s Surgisis.

The FDA has also previously approved similar devices for use in urological treatments, hernia repairs and plastic and reconstructive surgeries of the head and face. Overall, the technology used for the implant has been used in more than 100,000 procedures worldwide, according to the press release.