FDA Approval For Abbott’s Healon EndoCoat Protective Gel for Cataract Surgery

“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”

In short

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

Background

Healon Endocoat OVD is a clear, viscous, protective gel which 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.

Abbott says the surgical delivery system for its 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.

The product can be used in combination with any other Healon products such as Healon OVD, Healon GV OVD or Healon5 OVD and will begin shipping immediately in the United States.

Clinician comments

“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.”

Company comments

“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.”

OUS Availability

Healon EndoCoat OVD is already available in Europe, Canada and New Zealand.

Source: Abbott, PR Newswire