FDA approves Abbott’s Healon EndoCoat OVD device

AbbottJul 4 2012

Abbott announced today that it has expanded its Healon® family of ophthalmic viscosurgical devices (OVDs) with the U.S. Food and Drug Administration approval of Healon EndoCoat OVD, a device intended for use as a surgical aid in cataract extraction and intraocular lens (IOL) implantation.

This clear, viscous, protective gel formula is injected into a patient's eye to protect and coat the eye during surgery, reducing trauma to the inside layer of the cornea and other surrounding tissues.

The surgical delivery system for Healon EndoCoat OVD includes a number of features for increased patient safety and ease of handling for the physician, including a smaller delivery device and improved ergonomics for a smooth and consistent delivery of the formula into the eye.

"A dispersive OVD is highly desirable at the beginning of the cataract removal process to help protect the eye from nuclear particles and ultrasonic energy," said Roger F. Steinert, MD, Irving H. Leopold Professor and Chair, Director, Gavin Herbert Eye Institute, University of California, Irvine. "Healon EndoCoat OVD is ideal for this protective barrier. It has outstanding clarity and does not require refrigeration, which reduces surgicenter storage costs and improves ease of use compared to a cold syringe."  

With nearly 3 million patients undergoing cataract surgery each year in the United States, dispersives such as Healon EndoCoat OVD are expected to account for approximately 50 percent of the total OVD market in 2012, according to the independent ophthalmic research firm Market Scope.

Additionally, Healon EndoCoat OVD can be used in combination with any other Healon products such as Healon OVD, Healon GV OVD or Healon5 OVD.

"Healon OVDs offer the surgeon the ultimate in control, clarity and ease-of-use during every step of the cataract procedure," said Jim Mazzo, senior vice president, Abbott Medical Optics. "The U.S. approval of Healon EndoCoat OVD adds to a reliable portfolio of OVDs that has been known and trusted for more than 25 years and proven safe worldwide."

Healon EndoCoat OVD is also available in Europe, Canada and New Zealand. The product will begin shipping immediately in the United States.