CartiHeal receives FDA breakthrough device designation for Agili-C implant
Click Here to Manage Email Alerts
CartiHeal’s Agili-C implant for cartilage lesions in arthritic and nonarthritic joints has received FDA breakthrough device designation, according to a press release.
The Agili-C implant is also CE marked for use in cartilage and osteochondral defects of the knee, ankle and toe. The device can treat a variety of cartilage lesions, including single focal lesions to multiple and large defects in patients with osteoarthritis.
“We are extremely pleased that FDA granted the Agili-C implant breakthrough device designation,” Nir Altschuler, founder and CEO of CartiHeal, said in the release. “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,” he said.
Read more about
Click Here to Manage Email Alerts