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MedShape Solutions, Inc. receives CE mark approval for soft tissue fixation devices

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MedShape Solutions, Inc. announced that it received CE mark approval for the Morphix Anchor and the ExoShape Interference Fixation Device. According to a press release, receipt of the CE marking allows MedShape Solutions to market and sell the device in the European Free Trade Association and the European Economic Area, and the company is in discussions with third-party distributors across the region.

“The CE marking certification for MedShape’s Morphix and ExoShape devices is a crucial step toward our goal of expansion into the rapidly growing global soft tissue fixation market,” stated Jim Lorenzo, vice president of sales at MedShape Solutions, in the release. “Our proprietary shape memory technology platform allows us to design and market truly differentiated orthopedic devices that simplify the surgical procedure, reduce postoperative complications and restore musculoskeletal function. With favorable demographics and an active population, Europe represents a significant market opportunity for MedShape products.”

According to the release, Morphix is a suture anchor manufactured from MedShape’s proprietary shape memory PEEK Altera biomedical polymer. The device received 510(k) clearance from the U.S. Food and Drug Administration in September 2009 and has been fully commercially launched in the United States.

The ExoShape Interference Fixation Device also uses the PEEK Altera biomedical polymer to provide tibial fixation of soft tissue grafts during ACL reconstruction procedures. ExoShape received 510(k) clearance from the U.S. Food and Drug Administration in November 2010 and is currently being introduced in a phased launch to select sports medicine surgeons in the United States.