CE Mark for Z-Lig™Based on Clinical Success for Porcine-Derived ACL Replacement Device

It’s always interesting to see a new ACL fixation device, so the CE marking of Aperion Biologics, Inc.’s lead product, the Z-Lig™ ACLR device was sure to get our attention.

Background

Over 600,000 ACL reconstruction surgeries are performed around the globe annually, using either autografts or cadaveric allografts. History is littered with attempts at use of animal tissue or synthetic grafts to meet the high demands of the ACL replacement graft, all of which have either failed clinically or simply not matched the performance of the incumbent options.

Aperion has developed and patented a technique to make animal tissues compatible for challenging human applications. The core platform technology utilizes the Company’s proprietary Z-Process™, which removes the key antigens from animal tissues, followed by a conversion process that both stabilizes and sterilizes the tissue without affecting its biomechanical or biological properties. This creates functioning scaffolds capable of remodeling into healthy tissue. Aperion’s Z-Process™ is applicable to a variety of tissues used in orthopaedic, cardiovascular, plastic, general and other surgical specialties.

 

The company claims its Z-Lig™ provides a revolutionary new option, designed to provide immediate stability and function to the knee while promoting gradual remodeling into human tissue over time. Indeed it is the first engineered biologic device for treatment of revision and multiligament anterior cruciate ligament (ACL) knee reconstruction to be granted a CE Mark or to be approved anywhere worldwide.

A prospective, randomized, controlled clinical trial in Europe and South Africa demonstrated biological acceptance of Aperion’s bioengineered porcine tendons, re-establishment of knee stability, and remodeling over time into the patient’s own human ligament.

U.S. clinical evaluation is pending final discussions with the FDA on its approved pivotal clinical study of the Z-Lig™.

Company comments

“The international trial and CE Mark approval independently confirm the successful results we saw in our US pilot study which now has patients with Z-Lig™ devices 10 years after implantation,” says Kevin R. Stone, M.D., the founder of Aperion Biologics.

“The advantage of an off-the-shelf, biologic device is it avoids the weakening of the patient by taking their own tissue.”

Source: Aperion Biologics, Inc., PR Newswire

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