Agili-C Implant Receives FDA Breakthrough Device Designation: 251 Subjects Enrolled In IDE Clinical Study at 26 Sites in US, Europe and Israel
The company is currently conducting a pivotal IDE clinical study which is designed to evaluate the Agili-C™ implant superiority over the current surgical standard of care – microfracture and debridement.
Arlington Orthopedics Associates is one of 15 U.S. clinical sites participating in this randomized and controlled IDE clinical study. The primary study objective is to demonstrate the superiority of the Agili-C™ implant over the current surgical standards of care: microfracture and debridement in the treatment of large spectrum cartilage defects.
11/12/18: Agili-C™ Implant procedure was performed by site PI Eric J. Strauss, MD, orthopedic surgeon,NYU Langone Health's Sports Medicine Center NYC.