MedShape Solutions, Inc. Receives CE Marking Certification for Soft Tissue Fixation Devices
ATLANTA, April 26, 2011 /PRNewswire/ — MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, today announced that it has been notified of CE Marking approval for the Morphix(TM) Anchor and the ExoShape(TM) Interference Fixation Device. The CE Marking confirms that both medical devices comply with the essential requirements of relevant European health, safety, and environmental protection legislation, and have been subjected to conformity assessment procedures. Receipt of the CE Marking allows MedShape Solutions to market and sell the Morphix Anchor and the ExoShape Interference Fixation Device in the European Free Trade Association (EFTA) and the European Economic Area. The company has begun discussions with third party distributors across the region.
Morphix is a novel suture anchor manufactured from MedShape’s proprietary shape memory PEEK Altera(TM) biomedical polymer. Suture anchors are commonly used in a variety of surgical procedures that require the reattachment of damaged or worn ligaments and tendons to bone. 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 U.S.
The ExoShape Interference Fixation Device also utilizes MedShape’s PEEK Altera biomedical polymer to provide simple and secure tibial fixation of soft tissue grafts during Anterior Cruciate Ligament (ACL) reconstruction procedures. ExoShape received 510(k) clearance from the U.S. Food and Drug Administration in November 2010 and is currently being rolled out in a phased launch to select sports medicine surgeons across the U.S.
“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. Our proprietary shape memory technology platform allows us to design and market truly differentiated orthopedic devices that simplify the surgical procedure, reduce post operative complications, and restore musculoskeletal function,” said Jim Lorenzo, vice president of Sales at MedShape Solutions. “With favorable demographics and an active population, Europe represents a significant market opportunity for MedShape products.”
About MedShape Solutions, Inc.:
MedShape Solutions, Inc. is a privately held medical device company focused on developing orthopedic devices from proprietary shape memory technology. In June 2010, the company’s initial product, the MORPHIX(TM) Suture Anchor, received the prestigious Gold Award at the Medical Device + Design Excellence Awards (MDEA) meeting, based on its superior design and proprietary shape memory polymer. For more information about how MedShape is Shaping the Future of Orthopedics(TM), visit www.medshape.com.
ExoShape, PEEK Altera, MORPHIX, and Shaping the Future of Orthopedics are trademarks of MedShape Solutions, Inc.
SOURCE MedShape Solutions, Inc.