OSI is an ISO 13485:2003 registered company.
FDA Clearance Allows Sale to Surgeons in U.S.
Winston-Salem, NC “February 21,, 2011″ Ocular Systems, Inc. (OSI) announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the company’s human corneal endothelium delivery instrument, the EndoSerter®. The device delivers a corneal endothelial allograft measuring 8.5mm in diameter and 175µm in central thickness through a single 4 mm incision during endothelial keratoplasty procedures. Endothelial keratoplasty, a type of corneal transplantation that does not require a full-thickness graft, has become the treatment of choice for restoring corneal clarity to patients with failed endothelium function.
“Today’s announcement represents the successful culmination of a nearly two-year effort by Ocular System’s staff, our manufacturing partner, advisors, and surgeons to bring EndoSerter® to the U.S. market,” commented OSI CEO Jerry Barker. “We are proud that our device is the first cleared by FDA for insertion of endothelial cells that restore corneal transparency,” Mr. Barker continued.
“Each year approximately 18,000 patients in the U.S. 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,” Barker concluded.
EndoSerter® Sales and Ordering
For EndoSerter® information and ordering, please contact Ocular Systems at (336) 784-4603 or firstname.lastname@example.org. International customers should visit the Company website: www.ocularsystemsinc.com. The EndoSerter® will be featured at Booth #425 during the upcoming ASCRS meeting, San Diego, CA, March 25-29, 2011.
About Ocular Systems, Inc.
Ocular Systems is located in the Piedmont Triad Research Park, Winston-Salem, NC. It was the first facility dedicated to the processing of human corneal tissue for endothelial replacement surgeries. Founded in 2004, the Company is an FDA-registered human tissue establishment and device manufacturer, and is also ISO 13485 registered. The Company makes the EndoSerter® and EndoSaver®. The EndoSaver® has been cleared for sale in Europe and other countries. The devices are protected by U.S. and International patent applications.
For more information about Ocular Systems, Inc. and the EndoSerter®, please contact Anna Tirrell at (336) 784-4603 or email@example.com.