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Corneal endothelium device
The FDA has granted Ocular Systems Inc. (OS) 501(K) clearance to market its human corneal endothelium delivery instrument, the EndoSerter. For use during endothlelial keratoplasty, this instrument delivers a corneal endothelail allograft less than or equal to 8.5 mm in diameter and less than or equal to 175 micrograms in central thickness through a single 4-mm incision.
Winston-Salem, NC-The FDA has granted Ocular Systems Inc. (OSI) 510(k) clearance to market its human corneal endothelium delivery instrument, the EndoSerter. For use during endothelial keratoplasty, this instrument delivers a corneal endothelial allograft ≤8.5 mm in diameter and ≤175 μm in central thickness through a single 4-mm incision.
“We are proud that our device is the first cleared by the FDA for insertion of endothelial cells that restore corneal transparency,” said Jerry Barker, chief executive officer of OSI. “Each year [about] 18,000 patients in the United States have endothelial cell replacement surgery. OSI looks forward to making this device available to U.S. surgeons and providing them a new opportunity to benefit their patients.”
