March 16, 2005.
Kansas City Business Journal
KANSAS CITY-- The FDA-cleared Ex-PRESS(TM) Mini Glaucoma Shunt was found to be "safe and effective" when it was implanted in 24 eyes of 23 patients with severe open angle glaucoma--the most common form of glaucoma, affecting some three million Americans.
Of note, 16 of the 24 eyes (66 percent) had previously failed the "gold standard" procedure for treating glaucoma: i.e., trabeculectomy. The remaining eight (33 percent) were deemed "high risk for failure" and therefore contraindicated for a trabeculectomy procedure. Nevertheless, using the Ex-PRESS(TM) Mini Glaucoma Shunt, intraocular pressure ("IOP") was "significantly reduced" in all patients, on average by 50 percent. Increased IOP causes glaucoma.
"The search for the perfect glaucoma device has continued for nearly a century," said the clinical study's lead investigator, Elie Dahan, MD, Mmed Ophth, Department of Ophthalmology, University of the Witwatersrand, Johannesburg, South Africa. "This mini shunt procedure is relatively simple and can be performed in less than half the time of a trabeculectomy. Equally important, the Ex-PRESS(TM) device is biocompatible, and its structure ensures minimal tissue trauma. In addition, no removal of scleral tissue and good aqueous flow control (limited by the 50-micron device lumen) suggest that the Ex-PRESS procedure is less complicated and more predictable than the gold standard, trabeculectomy."
"Three million Americans have glaucoma, and half of them do not know it," added Haral A. Orbach, Director of Marketing for Optonol Ltd. (www.optonol.com), the manufacturer and marketer of the Ex-PRESS(TM) Mini Glaucoma Shunt. "Glaucoma is a chronic disease that silently steals eyesight. Fortunately, Ex-PRESS(TM) now offers hope for thousands of victims a year who may not have had access to physicians who could perform the complicated alternative procedure, or who could not afford it.
"Ex-PRESS(TM) is reimbursed by insurers. And it is a straightforward and simple procedure that can be easily adopted by most eye surgeons throughout the United States," said Mr. Orbach.
Glaucoma is a disease usually characterized by an increase in pressure within the eye. This may, in time, result in damage to the optic nerve, loss of peripheral or side vision, and ultimately blindness. The higher the pressure within the eye, the greater the chance of damage to the optic nerve. Approximately 10 million Americans have elevated eye pressure ("intraocular pressure"), which places them at risk for the onset of glaucoma. Eighty thousand Americans are already blind from the disease. African-Americans have a five-fold greater risk of developing glaucoma.
Measurement of intraocular pressure ("IOP") is an important part of any eye exam in patients over 50 and/or risk groups. The IOP is determined by a balance of the eye's production and drainage of aqueous humor (the clear fluid inside the eye) from the anterior chamber into the trabecular meshwork. If the IOP is elevated, it can cause pressure within the eye to increase and damage the optic nerve.
Optonol is a privately held medical technology company founded by a group of experienced clinicians, engineers and entrepreneurs. The Company's initial area of focus is the development of innovative devices for ophthalmologic applications. Its first product in this field is the patented Ex-PRESS(TM) Mini Glaucoma Shunt, a microscopic-sized implant that significantly reduces intraocular pressure. Optonol's U.S. headquarters are located in Kansas City, Missouri. The Company is headquartered in Neve-Ilan, Israel, and has operations in Zug, Switzerland.
Source URL: http://kansascity.dbusinessnews.com/shownews.php?newsid=15287&type_news=latest.
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