Aperion Biologics Initiates Clinical Trial of Z-Lig Device
According to the company, 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.
The study results will be used to support regulatory approvals and clinical acceptance of the Z-Lig ACLR device in select markets outside of the US.
The ACL is the most commonly injured knee ligament. Over 800,000 knee ligament reconstruction surgeries are estimated to be performed each year worldwide.
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 only known biological alternative to human tissue for ACL replacement in clinical evaluation.
Since Z-Lig is a biological implant that maintains a mechanically stable scaffold, it 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 successfully demonstrated safety and feasibility during the two-year evaluation.
Daniel Lee, CEO of Aperion Biologics, said: â€œInitiating the Z-Lig ACLR clinical trial is an important step not only for our technology and the company but also for the field of orthopaedics. Z-Lig ACLR represents an opportunity to provide a biologic graft sourced from non-human tissue.
â€œThis device is a functional scaffold which supports the regeneration of the patient's own tissue. It has been a long-standing goal for surgeons and the industry globally to have a readily available, off-the-shelf ACL graft.â€
Can the company get positive results from this trial?
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