Aperion Biologics Inc. announced that the company has received a CE mark from the European Union and other accepting territories for its Z-Lig ACLR device.
The Z-Lig is designed to provide instant stability and function to the knee while promoting gradual remodeling into human tissue. According to a company press release, the approval is the first time an engineered biologic device for treatment of revision and multiligament ACL reconstruction was granted a CE mark or approved worldwide.
“[The] CE mark approval independently confirm[s] the successful results we saw in our U.S. pilot study, which now has patients with Z-Lig devices 10 years after implantation,” Kevin R. Stone, MD, founder of Aperion Biologics, stated in the release. “The advantage of an off-the-shelf, biologic device is it avoids the weakening of the patient by taking their own tissue.”