MedShape Makes Full Release of ExoShape Soft-Tissue Fastener

MedShape Inc., a manufacturer of shape-memory orthopedic devices, has fully released its ExoShape Soft Tissue Fastener in the United States. The device is a two-part PEEK interference fixation device that is designed to simplify and improve soft-tissue graft fixation during anterior cruciate ligament (ACL) reconstructive surgery. The company had a “soft” launch of the product last year.

Shape memory materials are considered “mechanically active smart materials.” They are defined by their ability to recover large deformations to their original shape on command in a controlled manner. Medical devices using shape memory materials can be implanted through small incisions and be deployed to a larger size or different shape within the body to fixate tissues, repair fractures or restore normal anatomy.

The target market is a good size. Company officials note that more almost a million soft-tissue ACL procedures were performed in 2010, and that number is expected to grow steadily. The initial phase of the ExoShape launch last year featured sizes from 6-9 mm in diameter and 28-30 mm in length. Mid-year the sizes diameters of 10, 11 and 12 mm were added. The company received U.S. Food and Drug Administration 510(k) clearance early last year.

“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 Atlanta, Ga.-based MedShape. “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.”

According to Jacobus, ExoShape’s design supports reconstruction techniques as they continue to evolve to more accurately replicate the complex functionality of a patient’s natural ACL. The system uses a 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, according to the company. 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 attempts to address these issues.

MedShape is a privately held medical device company working to develop a portfolio of surgical solutions based on its patented shape memory technologies in the areas of sports medicine, joint fusion and musculoskeletal trauma products.