MedShape Solutions, Inc. Announces Extension of ExoShapeâ„¢ Product Line in Response to Surgeon Demand
Medical device manufacturer receives FDA Special 510(k) clearance for larger sizes of the ExoShape interference fixation device
ATLANTA (June 20, 2011) - MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, today announced it has developed new, larger sizes of its ExoShape CL, a two-part PEEK Altera interference fixation device that simplifies and improves soft tissue graft fixation during anterior cruciate ligament (ACL) reconstructive surgery. The announcement comes after MedShape received the U.S. Food and Drug Administration's Special 510(k) clearance, which is required prior to the marketing of modified products previously cleared under a Traditional 510(k).
The initial phase of the ExoShape launch earlier this year featured sizes from 6-9 mm in diameter and 28-30 mm in length. The new sizes retain the 30mm length but are available in diameters of 10, 11, and 12 mm. "The ExoShape soft launch to a select group of surgeons generated an overwhelmingly positive response, and identified great interest in larger sizes to accommodate all patient needs," said Rick Leach, vice president of marketing for MedShape. "Due to that demand, we responded quickly to expand the ExoShape product line. The larger sizes will allow surgeons to perform revision surgeries on patients who have previously undergone ACL reconstruction but have been re-injured and also to utilize a transtibial reconstruction technique where the surgeon's choice of femoral fixation device may require an oversized tibial tunnel and, therefore, a larger tibial device to achieve secure graft fixation."
ExoShape preserves soft tissue graft orientation, provides superior graft protection and class-leading fixation strength. The design supports the evolution of reconstruction techniques to more accurately replicate complex native ACL functionality. The unique fixation device features a non-rotational deployment technique that preserves the surgeon's desired soft tissue graft bundle orientation and tension during single-tunnel double-bundle procedures, eliminating undesirable variables common to previous techniques.
Over a quarter-million soft tissue ACL procedures were performed in 2010, and that number is expected to grow steadily. ExoShape is profoundly improving the results for these ACL patients and the company will continue to further refine and enhance the surgical instrumentation following overwhelmingly positive surgeon engagement and feedback. A full launch of ExoShape is scheduled for Q1 2012, and MedShape is actively developing a version of ExoShape for tenodesis applications in the upper and lower extremities.
For more information on ExoShape, please visit www.medshape.com .
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 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 visit www.medshape.com.
ExoShape, PEEK Altera, MORPHIX, and Shaping the Future of Orthopedics are trademarks of MedShape Solutions, Inc.