ATLANTA, Feb. 8, 2011 /PRNewswire/ -- MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, today announced the introduction and first human clinical use of 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. After receiving 510(k) clearance from the U.S. Food and Drug Administration, the product was used successfully in a knee ligament reconstruction procedure performed by Champ L. Baker, Jr., M.D., at the Jack Hughston Memorial Hospital in Phenix City, Alabama. "I was impressed with the performance of the ExoShape device," commented Dr. Baker. "I believe that many surgeons will recognize the significant benefits of the ExoShape device and will adopt it for their soft tissue fixation procedures." MedShape intends to initiate a full market release of the product in June 2011.
ExoShape's design supports the evolution of reconstruction techniques to more accurately replicate complex native ACL functionality. This 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.
When used with soft tissue grafts, traditional interference screws exhibit low fixation strength and can damage the graft during insertion. Many surgeons have turned to "sheath-and-screw" devices that offer improved graft fixation and graft protection. However, sheath-and-screw solutions can compromise graft bundle orientation due to sheath rotation within the tibial tunnel, the result of the significant manual torque required to drive the screw into the sheath and achieve adequate graft fixation. The need to drive screws in a direction counter to the desired direction of graft tension can also introduce undesirable laxity into the graft construct.
ExoShape addresses these issues with a series of design improvements:
"ExoShape solves a significant problem common to a very large number of surgeries," said Rick Leach, vice president of Marketing at MedShape Solutions. "Over a quarter-million soft tissue ACL procedures were performed in 2010, and that number is expected to grow steadily. ExoShape will profoundly improve results for this increasingly common surgical procedure."
For more information on ExoShape, or to view animation of ExoShape in action, 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.Media Contact:Jenn HarrisonCarabiner Communications firstname.lastname@example.org
|SOURCE MedShape Solutions, Inc.|
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