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FDA clearance for ExoShape femoral soft tissue fastener

Manufacturing Group | February 10, 2014

MedShape’s shape memory polymer device simplifies and streamlines ACL reconstruction; set for release this month.

FDA clearance for ExoShape femoral soft tissue fastener

Atlanta - Officials from medical device manufacturer, MedShape Inc. announce that the company 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. Set to launch this month, the ExoShape femoral soft tissue fastener 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.

The ExoShape femoral soft tissue fastener complements the tibial version, launched by MedShape in 2011. The implant is equipped with several features uniquely designed to accommodate the femoral anatomy and loading conditions. These design features include a Tendon Loop for shuttling the soft tissue graft into the bone tunnel, allowing for at least 20 mm of graft to be placed inside the tunnel. The ExoShape Femoral also has two locking modes that work in congruence to provide secure fixation: 

  • Shape Memory Wings that deploy and lock into cancellous bone 
  • Expandable Block Lock technology that provides uniform graft compression and aperture fixation 

Dr. John Uribe of the UHZ Sports Medicine Institute in Coral Gables, Fla., currently uses the tibial version for his ACL procedures and is earnestly awaiting the release of ExoShape Femoral. "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. Applying compression is important with promoting graft to bone healing," said Dr. Uribe. "I believe many surgeons will recognize the benefits of this system and adopt it for their ACL reconstruction procedures."

Likewise, Dr. Geoffrey Higgs from Advanced Orthopaedics in Richmond, Va., and also a user of the tibial version, shares in Uribe's sentiments. "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. This device will greatly simplify my procedure and give me the confidence that I am getting strong, reliable fixation."

Developed in collaboration with several key surgeons (including Drs. 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. ExoShape's straightforward, non-rotational insertion and expansion technique preserves the surgeon's desired soft tissue graft bundle orientation and recreates the anatomic two-bundle ACL at aperture with a single tunnel. Available in sizes 8mm to 11mm and 21mm in length, ExoShape Femoral will come pre-loaded on a delivery system with a flexible rod that enables simple tendon shuttling and easy 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." 

Source: MedShape Inc.

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