The IDE study is currently ongoing in the US, EU and Israel, aiming for a FDA PMA application.
| KFAR SABA, Israel and ANTWERP, Belgium, Aug. 28, 2018 /PRNewswire/ -- CartiHeal, developer of Agili-C, proprietary implant for the treatment of joint surface lesions, and the Principle Investigator Professor Peter Verdonk, MD, PhD of Antwerp Orthopedic Center at AZ Monica hospital and Antwerp University, announced today the successful enrollment of the first Belgian patient in the Agili-C IDE pivotal study. The IDE study is currently ongoing in the US, EU and Israel, aiming for a FDA PMA application. Over 80 patients have been enrolled. The trial’s objective is to demonstrate the superiority of the Agili-C implant over surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in arthritic knees and also in knees without degenerative changes. “To date, I have operated on over 30 patients with the Agili-C implant in CartiHeal’s previous studies and witnessed excellent clinical outcome. Some of my early patients are with over 4 years follow-up and are very satisfied. I am excited to perform the first Belgian Agili-C implantation in the IDE Pivotal Study,” said Prof. Verdonk. “The patient, a 48-year-old male, was randomized to the Agilli-C arm and treated with 2 Agili-C implants in AZ Monica hospital in Antwerp. I’ve treated similar indications previously with this implant and hope that following this surgery the patient will be able to return to normal, painless activities.” Nir Altschuler, CartiHeal’s founder & CEO said: “We are excited to add Belgium to the participating countries in our multinational IDE Study. Prof. Verdonk was one of the first surgeons to use our implant in previous European trials and we are pleased that he has elected to be a Principal Investigator in this study too. We look forward to continuing our fruitful collaboration with Prof. Verdonk.” CartiHeal’s cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C was implanted in a series of trials conducted in leading centers in Europe and Israel, in over 400 patients with cartilage lesions in the knee, ankle and great toe. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis. About CartiHeal CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints. In the United States the Agili-C implant is not available for sale - it is an investigational device limited for use in the IDE study. Contact info@cartiheal.com
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