Anamed’s PermaVisionΠIntracorneal Lens Receives CE Mark

January 05, 2001 Posted by Anamed, Inc.

 

Anamed, Inc., a California biomedical technology company, announced on 1 August that it’s PermaVision(R) intracorneal lens has received the CE Mark and approval for commercial distribution throughout the European Union (EU). The company plans an EU launch of the PermaVision lens to correct hyperopia (farsightedness) up to + 6 diopters in mid-2002.

"I am as excited by this technology as I was when I did my early Lasik procedures in 1995. This procedure goes a long way to becoming the ideal refractive procedure which is additive, adjustable and reversible," said clinical investigator Dr. Sheraz Daya, MD, of the Queen Victoria Hospital, East Grinstead, UK. Anamed is the only company with approval to commercialize intracorneal lenses. The lens is implanted in a sutureless synthetic keratophakia procedure to correct refractive errors of the eye. While keratophakia has been under development for the past 50-plus years, it took Anamed’s proprietary Nutrapore material to make the procedure viable. The Nutrapore material from which the PermaVision lenses are made mimics the properties of the stroma for water content, refractive index, optical clarity, fluid transport, and permeability of metabolites and oxygen. The micron-precisioned lenses are placed inside the cornea in a sutureless procedure to correct refractive errors of the eye. A hinged flap is made in the cornea—just as in LASIK—, the lens is placed under this flap and centered over the pupil. The flap is then folded back over the lens and the eye. Fluid dynamics keeps the lens and the flap in place. No stitches are necessary. An on-going international, multi-center clinical trial was opened in December 1999, expanded to four sites in 2000 and to 14 centers in 11 countries during 2001. In addition, the PermaVision lens has successfully completed long-term porcine evaluations. An FDA-approved clinical trial of the PermaVision lens will begin in fall 2001. "The overall patient data indicates that the PermaVision lens can correct vision without a laser" according to medical monitor Dr. Herbert Kaufman, MD, Professor of Ophthalmology and Director of the LSU Eye Center in New Orleans, LA, USA "perhaps even more important, the flap can be lifted and the lens removed or exchanged since tissue is not ablated or destroyed." About Anamed, Inc. Anamed, Inc., is a privately held biomedical technology company that specializes in innovative, ophthalmic surgery technologies. Anamed, Inc., founded in 1996, is headquartered at 25651 Atlantic Ocean Drive, A1 Lake Forest, California. For more information visit its web site at www.anamedinc.com. For further information, please contact Adrian Koppes of Anamed +1 949-707-2740, ext. 102.

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