EyeYon Medical announced today that it received CE mark approval for its EndoArt synthetic endothelium replacement implant.
Tel Aviv, Israel-based EyeYon designed EndoArt to replace dysfunctional endothelium in patients awaiting human donor tissue as a first-line treatment for patients with chronic corneal edema, as patients with a nonfunctioning endothelium experience excess fluid flowing into the cornea, which can produce severe vision loss, pain and irreversible scarring of the human tissue.
The implant enables doctors to treat endothelial-related chronic corneal edema with minimally invasive surgery. According to a news release, the system became the only ophthalmic device globally to receive both China’s Innovative Device Status and U.S. breakthrough device designation from the FDA.
EndoArt proved its safety and effectiveness in clinical trials across Europe, while other clinical trials are currently underway in India and Israel.
“We are proud to receive CE mark for our unique EndoArt implant, which is set to transform the way patients with chronic corneal edema are treated,” EyeYon Medical co-founder & CEO Nahum Ferera said in the release. “This important approval enables us to work closely with healthcare providers across Europe to help patients who suffer from corneal edema regain their sight and quality of life with a simple, accessible and cutting-edge solution. We would like to thank our European partners for the journey we shared over the past years to advance our technology in the continent.”