MedShape reports first clinical use of ExoShape PEEK Altera interference fixation device for ACL surgery

MedShape Solutions, Inc.Feb 9 2011

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:

• The ExoShape device's unique deployment gun facilitates full expansion of the PEEK Altera shape memory sheath without rotational motion, thereby accurately preserving the surgeon's desired graft bundle orientation.
• The ExoShape deployment gun and deployment 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 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 deployment gun provides a convenient mechanical advantage for easy deployment of the ExoShape PEEK Altera shape memory sheath.

"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."