Aperion Biologics has begun enrollment and implantation of the first patients in the clinical trial of its Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) Device for the treatment of ligament injuries of the knee.
The primary objective of the multicenter study is to provide additional evidence of the safety and performance of Z-Lig in the reconstruction of patients’ knees with primary ACL ruptures.
Seven sites in Europe and one site in South Africa are participating in this clinical trial.
Aperion’s Z-Lig is a proprietary immunochemically modified porcine tissue-based, sterile medical device for implantation to reconstruct a ruptured Anterior Cruciate Ligament (ACL).
Z-Lig is the biological alternative to human tissue for ACL replacement in clinical evaluation, maintains a mechanically stable scaffold, and can become populated and remodeled with the patient’s own cells (similar to human-sourced tissue).
Aperion previously completed a clinical study for Z-Lig in the US in which the grafts demonstrated safety and feasibility during the two-year evaluation.