The first patient was enrolled in CartiHeal’s Agili-C implant investigational device exemption pivotal study at The Ohio State University Wexner Medical Center in Columbus.
Here are four things to know:
1. Christopher Kaeding, MD, and David Flanigan, MD, performed the case on a patient with mild osteoarthritis and two cartilage lesions on both femoral condyles. The patient was treated with two Agili-C implants for each condyle.
2. The OSU Wexner Medical Center is one of 30 sites in the FDA IDE trial aiming to demonstrate the superiority of the Agili-C implant over the current standard of care to treat cartilage defects in arthritic and non-arthritic knees.
3. Agili-C is a cell-free, off-the-shelf implant for cartilage and osteochondral defects in traumatic and osteoarthritic joints. The implant is porous, biocompatible and comprised of a resorbable biphasic scaffold consisting of interconnected natural inorganic calcium carbonate.
4. The Agili-C implant is CE marked for use in cartilage and osteochondral defects. It has been implanted in more than 400 patients with knee, ankle and big toe cartilage lesions in clinical trials throughout Europe and Israel.