The US Food and Drug Administration has granted a joint implant device from Israel's CartiHeal "Breakthrough Device Designation," which expedites the FDS development, assessment, and review process.
The FDS reserves this designation for medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as CartiHela's Agili-C, which treats cartilage lesions in arthritic and non-arthritic joints.
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CartiHeal is currently conducting a pivotal IDE clinical study which is designed to evaluate the Agili-C implant's efficacy over the current surgical standard of care. Final study results are expected next year.
