FDA Approves Knee Cartilage Repair Implant

FDA has approved a CartiHeal PMA for its Agili-C implant, indicated for treating an International Cartilage Repair Society (ICRS) Grade III or above knee-joint surface lesion with a total treatable area of 1-7cm2 and without severe osteoarthritis. Approval was based on data from a two-year IDE pivotal clinical study, which the company says confirmed superiority of the Agili-C implant over the current surgical standard of care (microfracture and debridement) for treating knee joint surface lesions, chondral and osteochondral defects. The study involved 251 subjects, 167 in the Agili-C arm and 84 in the standard-of-care, in 26 sites both in and outside the U.S.

CartiHeal describes the device as a cell-free, off-the-shelf implant that is a “porous, biocompatible, and resorbable bi-phasic scaffold, consisting of interconnected natural inorganic calcium carbonate (aragonite).”