FDA Approves New Device for Endothelial Keratoplasty

Steven Fox

February 24, 2011

February 24, 2011 — The US Food and Drug Administration (FDA) has approved a new donor tissue delivery device for use during endothelial keratoplasty. The company that makes the device says it helps surgeons deploy allografts correctly, requires no additional tissue manipulation, and simplifies and shortens the procedure.

The device, known as EndoSerter, is made by Ocular Systems, Inc. It has already been approved for use in Europe and Canada.

During the past several years, selective endothelial keratoplasty has gained in popularity when patients need to have a thin layer of endothelial cells replaced but do not require a full corneal transplant.

The other primary technique for correcting endothelial failure — penetrating keratoplasty — can result in the loss of a significant volume of otherwise normal corneal tissue. In addition, several risk factors are associated with penetrating keratoplasty, including postoperative astigmatism and graft rejection.

In background publications, the company says the EndoSerter is a single-use, disposable device and the only delivery system capable of small-incision clear cornea surgery that requires no additional instrumentation. Advantages of the device include a smaller wound and no needle for retrobulbar block, which eliminates risk for hemorrhage or globe perforation. The company also claims the device increases efficiency and saves money because it eliminates the need for sutures, conjunctival incision, or cautery.

The device is designed to gently retract the graft, with minimal manipulation, into an insertion sheath, and then deploy the tissue through a 4-mm wound without plunging, pulling, or folding.

Tissue is deployed in the anterior chamber by placing the tip of the insertion sheath at the far edge of the recipient bed, the company says, and then using a finger control on the device that exposes the graft. As the graft is gently deployed, the surgeon is able to control precise placement without interference from additional surgical instruments. Placement of the graft is complete once the insertion sheath is withdrawn back through the wound, centering the graft in the bed.

The company says the device can transport graft tissue up to 175 μm thick and 8.5 mm or smaller in diameter.

Common indications for endothelial replacement surgery are Fuch's endothelial dystrophy and postcataract edema. Fuch's endothelial dystrophy is an inheritable genetic disease that results in loss of endothelial cells and formation of abnormal extracellular matrix. The disease affects about 1 in 20 people older than 40 years and is diagnosed 3 times more frequently in women than in men.

The FDA's approval of the EndoSerter is based in part on 2 clinical studies that the company plans to present at ophthalmology meetings this spring.

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