EyeYon Medical granted CE mark for EndoArt implant to treat chronic corneal edema
Following the positive results of clinical trials, EndoArt, a polymer film implant designed to adhere to the posterior corneal surface to treat chronic corneal edema, was granted the European CE mark.
EndoArt (EyeYon Medical) implantation will “transform the way patients with chronic corneal edema are treated,” Nahum Ferera, co-founder and CEO of EyeYon Medical, said in a press release. Placed at the center of the posterior surface of the cornea, the implant blocks the excessive transfer of fluid that causes the edema, rebalancing corneal hydration. This simple and minimally invasive surgical procedure might help avoid or at least delay the need for endothelial transplantation in patients with endothelial dysfunction and may offer an alternative solution to the global shortage of corneal donations.
“The EndoArt opens up a new vision for the future: availability, ease of use and cost reduction in treating patients with endothelial failure,” Ruth Lapid-Gortzak MD, PhD, trial principal investigator from the Amsterdam University Medical Center, the Netherlands, said in the release.
Other centers involved in the European trials include the University of Heidelberg, Germany, and the Instituto de Microcirugía Ocular in Barcelona, Spain. Other clinical trials are underway in India and Israel.
“Our trials have demonstrated decrease in corneal thickness in all patients, and in patients with visual potential, there has been an improvement in visual acuity, with no evidence of detrimental metabolic effect in the recipient cornea,” Lapid-Gortzak said.
In May, the EndoArt received breakthrough device designation from the FDA as well as innovative device status in China.