New Device for ACL Surgery

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MedShape Solutions, Inc., based in Atlanta, Ga., reported the first human clinical use ofits ExoShape CL, a two-part PEEK Altera interference fixation device that is designed to simplify and improve 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, Ala.

“I was impressed with the performance of the ExoShape device,” Baker said. “I believe that many surgeons will recognize the significant benefits of the ExoShape device and will adopt it for their soft tissue fixation procedures.”

Privately held MedShape plans a full market release of the product in June.

According to company officials, 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.

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 also can introduce undesirable laxity into the graft construct.

According to the company, ExoShape addresses these issues with a series of design improvements.

The ExoShape device’s 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 deployment gun and deployment cartridge combination use a closed force loop for sheath expansion, eliminating the need for forward force on the sheath, allowing 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.

MedShape officials hope to capitalize on the more than quarter-million soft tissue ACL procedures that were performed in 2010. The number of procedures is expected to grow steadily.

Exoshape in action: www.medshape.com/exoshape.