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Ocular Systems' corneal graft delivery system reaches the US

This article was originally published in Clinica

Executive Summary

EndoSerter, a human corneal endothelium delivery instrument developed by Ocular Systems, has gained 510(k) clearance from the US FDA. The device delivers a corneal endothelial allograft measuring around 8.5mm in diameter and 175microns in central thickness through a single 4mm incision during endothelial keratoplasty procedures. Endothelial keratoplasty is a type of corneal transplantation that does not require a full-thickness graft. Endoserter is the first device to be cleared by the FDA for insertion of endothelial cells that restore corneal transparency, Winston-Salem, North Carolina-based Ocular Systems says. Each year approximately 18,000 patients in the US have endothelial cell replacement surgery.

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