MedShape Gets FDA OK for Femoral Version of ACL Reconstruction Device

MedShape Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ExoShape Femoral Soft Tissue Fastener for use in soft-tissue graft fixation on the femoral side of the knee joint during anterior cruciate ligament (ACL) reconstructive surgery.

The Atlanta, Ga.-based company develops shape-memory orthopedic devices.

Set to launch in February, ExoShape, according to the company, is the only femoral fixation device fabricated completely out of PEEK Altera polymer and offers dual locking modes in cancellous bone and at aperture to achieve complete anatomic ACL reconstruction. This most recent version of the ExoShape complements the tibial version, launched by MedShape in 2011.

According to MedShape, the implant is equipped with several features designed to accommodate the femoral anatomy and loading conditions, including a tendon loop for shuttling the soft-tissue graft into the bone tunnel, allowing for at least 20 millimeters of graft to be placed inside the tunnel. The device also has two locking modes that work in congruence to provide secure fixation: shape-memory wings that deploy and lock into cancellous bone; and expandable block lock technology that provides uniform graft compression and aperture fixation.

“The ExoShape Femoral is an unrivaled device with the use of shape memory PEEK to provide effective soft-tissue graft compression and fixation as well as an easy insertion method,” said John Uribe, M.D., of the UHZ Sports Medicine Institute in Coral Gables, Fla., who currently uses the tibial version of the device. “Applying compression is important with promoting graft to bone healing. I believe many surgeons will recognize the benefits of this system and adopt it for their ACL reconstruction procedures.”

“I am looking forward to using the ExoShape device on the femoral side of my ACL repair surgeries because of its non-rotational deployment and ability to compress the graft at aperture,” said Geoffrey Higgs, M.D., from Advanced Orthopaedics in Richmond, Va., and also a user of the tibial version. “This device will greatly simplify my procedure and give me the confidence that I am getting strong, reliable fixation.”

Developed in collaboration with surgeons (including Uribe and Higgs), the use of MedShape’s proprietary shape memory PEEK Altera enables the fastener 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, according to MedShape officials. The non-rotational insertion and expansion technique are designed to preserve the surgeon’s desired soft-tissue graft bundle orientation and recreate the anatomic two-bundle ACL at aperture with a single tunnel.

Available in sizes 8-11 millimeters and 21 millimeters in length, ExoShape Femoral comes pre-loaded on a delivery system with a flexible rod that enables tendon shuttling and improved navigation across the joint for both transtibial and anteromedial approaches. The flexible rod and non-rotational deployment mechanism facilitates non-line-of-sight delivery along a curved path.

“We have discovered that orthopedic surgeons require speed, simplicity and performance in their devices. Using our shape memory technology, we have designed an ACL fastener that can be implanted quickly and easily, while still offering excellent fixation,” said Kurt Jacobus, CEO of MedShape. “Our shape memory technology also allows our implants to expand and compress the graft without inducing damage or rotating the graft. The addition of ExoShape Femoral now allows us to provide these benefits to both sides of an ACL reconstruction.”