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First Patient in New England Treated With the Agili-C(TM) Implant at CartiHeal's Pivotal Study
KFAR SABA, Israel, April 29, 2019 /PRNewswire/ -- Christian Lattermann, M.D., Chief of the Sports Medicine Service and Director of the Center for Cartilage Repair at Brigham and Women's Hospital in Boston, recently became the first surgeon in New England to enroll a patient in CartiHeal's FDA – IDE study.
Agili-C™ is an implant designed to regenerate the articular cartilage and its underlying subchondral bone in patients with painful cartilage defects in the knee. Prior to this study, the implant was tested in a series of clinical trials in Europe. Lattermann is one of 15 U.S. principal investigators participating in this randomized, controlled study.
"This study is different because we can treat multiple cartilage defects in knees with and without osteoarthritis," said Dr. Lattermann. "My first patient is a 36-year-old with a painful cartilage defect located in the central trochlea. This patient represents the general population with this type of cartilage pain who are eligible for this trial. My hope is that this study will help those who currently lack an optimal treatment option for their cartilage problems."
This IDE study is ongoing in the U.S., E.U. and Israel with over 170 patients already enrolled. CartiHeal is targeting an FDA premarket approval (PMA) if this study can demonstrate the superiority of the Agili-C implant over surgical standard of care procedures (microfracture and debridement) for the treatment of cartilage and osteochondral defects in knees, with and without degenerative changes.
Nir Altschuler, CartiHeal's founder & CEO said: "We'd like to congratulate Dr. Lattermann and his team at Brigham and Women's Hospital for the successful enrollment of the first patient in New England. We look forward to continuing our collaboration with him."
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