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.