Abbott, a global and broad-based health care company announced the expansion of its Healon family of ophthalmic viscosurgical devices (OVDs) by receiving the US Food and Drug Administration (FDA) approval for 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 three million patients undergoing cataract surgery each year in the United States, dispersives such as Healon EndoCoat OVD are expected to account for approximately 50 per cent 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 US 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.
Abbott Medical Optics is focused on delivering life-improving vision technologies to people of all ages. The company offers a comprehensive portfolio of cataract, refractive and eye care products. Products in the cataract line include monofocal and multifocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears.
Abbott is devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.