Express delivery and free returns within 21 days

Friday, July 1, 2022

MEDICAL DEVICE NEWS MAGAZINE

|

Contact us 561.316.3330

Agili-C Implant Receives FDA Breakthrough Device Designation: 251 Subjects Enrolled In IDE Clinical Study at 26 Sites in US, Europe and Israel

- Advertisement -

October 12, 2020

Agili-C implant has received FDA Breakthrough Device Designation. CartiHeal announced the news today. FDA’s Breakthrough Device Program is reserved for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients receive more timely access to these medical devices by expediting their development, assessment and review by FDA.

Agili-C Implant device receives FDA Breakthrough Device Designation

CartiHeal 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. In total 251 Subjects were enrolled in 26 sites in the US, Europe and Israel. The study includes Subjects with both mild to moderate osteoarthritis and focal defects, without arthritic changes. Final study results are expected next year.

“We are extremely pleased that FDA granted the Agili-C implant Breakthrough Device Designation,” said Nir Altschuler, CartiHeal’s Founder & CEO. “We look forward to working closely with FDA to expedite Agili-C’s review process, once the final IDE study results will be available, in order to provide a promising treatment for millions of patients who suffer from cartilage defects and currently lack good treatment options.”

SourceCartiHeal
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
spot_img

Other News of Interest

Executives on the Move

By using this website you agree to accept Medical Device News Magazine Privacy Policy