MedShape, Inc. Announces Full Commercial Release of ExoShape® Soft Tissue Fastener
ATLANTA, Jan. 17, 2012 /PRNewswire/ — MedShape, Inc., the industry leader in innovative shape memory orthopedic devices, today announced the full U.S. commercial release of the ExoShape® Soft Tissue Fastener, a two-part PEEK Altera® interference fixation device that greatly simplifies and improves soft tissue graft fixation during anterior cruciate ligament (ACL) reconstructive surgery. MedShape has shipped the first full launch instrumentation sets to its sales agents to support surgeon demand for the product following a successful soft launch during 2011.
“We undertook a controlled market introduction of the ExoShape product to key sports medicine surgeons last year and received a tremendous amount of valuable feedback. We used this detailed information to further enhance the instrumentation and refine the surgical technique,” said Kurt Jacobus, president and CEO of MedShape, Inc. “We firmly believe that the ExoShape Soft Tissue Fastener will fulfill our promise to surgeons to deliver a unique, effective and easy-to-use tibial soft tissue fixation system.”
Cutting-Edge Design Overcomes Traditional Screw and “Sheath and Screw” Flaws
ExoShape’s enhanced design supports reconstruction techniques as they continue to evolve to more accurately replicate the complex functionality of the native ACL. It employs a unique non-rotational deployment technique that preserves the surgeon’s desired graft bundle orientation and tension during single tunnel-double bundle procedures.
When used with soft tissue grafts, traditional interference screws exhibit low ultimate yield loads and can damage the graft during insertion. In an attempt to overcome these issues, surgeons have turned to “sheath-and-screw” devices that offer improved graft fixation and graft protection. However, these solutions may continue to compromise graft bundle orientation due to the sheath rotating within the tibial tunnel, as significant manual torque is required to drive the screw into the sheath and achieve adequate interference fixation of the graft. The need to drive screws into these devices in a direction counter to the desired direction of graft tension may also introduce undesirable laxity into the graft construct.
The ExoShape Soft Tissue Fastener addresses these key issues with a series of design improvements, most notably:
- The ExoShape® Soft Tissue Fastener’s unique deployment gun facilitates full expansion of the PEEK Altera® shape memory sheath without rotational motion, thereby preserving the surgeon’s desired graft bundle orientation.
- The ExoShape® Gun and ExoShape Cartridge combination utilizes a closed force loop for sheath expansion, eliminating the need for forward force on the sheath. This allows the surgeon to confirm desired graft tension prior to final device deployment. Graft tension remains unchanged during ExoShape deployment.
- The use of MedShape’s proprietary PEEK Altera® shape memory polymer enables the sheath to be pre-compressed to a low profile for easy insertion and then fully expanded for effective graft-to-tunnel compression and secure graft fixation.
- The ExoShape® Gun provides a convenient mechanical advantage for easy deployment of the ExoShape PEEK Altera® shape memory Sheath.
To request an onsite demonstration, or view animation of ExoShape in action, please visit the website at www.medshape.com or call MedShape, Inc at (404) 249-9155.
About MedShape, Inc.:
MedShape. We’re what the future feels like. It all began as an audacious idea at an elite engineering school to improve outcomes around orthopedic fixation devices. Fast-forward to today and the idea has evolved into a biomaterial sciences company that fuses brilliant design with surgical expertise. Now surgeons can use the most innovative orthopedic devices anywhere–unique devices created from our shape memory biomaterials that can transform and adapt inside the body. Together, we are dramatically improving the technology of soft tissue fixation, fracture repair and joint fusions.That kind of change isn’t just good–it’s great!
ExoShape and PEEK Altera are registered trademarks of MedShape, Inc.
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SOURCE MedShape, Inc.