The FDA-approved Ex-Press shunt is a miniature glaucoma drainage device. A simple, short procedure inserts the shunt at the edge of the colored part of the eye, the limbus.Glaucoma is a difficult and painful condition. The disease starts out as elevated pressure inside the eyeball. When eyes are in healthy condition, fluid is produced in the eye that circulates around and eventually drains near the edge of the cornea.
But for the 100,000 Americans who are diagnosed each year with glaucoma, that drainage is blocked, and the increased pressure pushes on and damages the optic nerve at the back of the eye. Usually glaucoma can be controlled with medication. Sometimes laser treatment is needed to reopen the drainage channels: but some people aren’t helped by any of those treatments.
Now a new device developed in Israel is providing hope and relief for glaucoma sufferers who have been previously dismissed as untreatable. Optonol’s Ex-Press shunt is an effective, long-term alternative to traditional glaucoma surgery and can significantly improve the quality of life of glaucoma patients by providing possible relief from life-long dependency on drug therapy.
The FDA-approved shunt is a miniature glaucoma drainage device, just the tiny spike at the end of the needle. A simple, short procedure inserts the shunt at the edge of the colored part of the eye, the limbus. The microscopic conduit drains excess fluid out of the eye and into the tissues surrounding the eye, where it can`t do any harm. The pressure reduction brings down the pain level and reduces the patient’s need for medications to relieve that pain.
Worldwide, there are an estimated 65 million cases of glaucoma. There are 3 million cases in the United States, but only one-half of those have been diagnosed. About 2% of people between the ages of 40 and 50, and 8% of those over 70, have elevated intraocular pressure in one or both eyes. There are 120,000 people in the United States who are blind as a result of glaucoma, which accounts for 9-12% of all cases of blindness.
The best candidate for the Ex-Press shunt is someone who has already failed other glaucoma treatments. But if a patient has already lost sight due to glaucoma, that loss is permanent. The shunt only slows or stops the process.
The device was developed by Optonol at their Neve Ilan offices outside of Jerusalem, and last year American optical giant Ciba Vision acquired the rights to market it in the United States and Canada. Since its introduction on the American market last year, there have been hundreds of cases implanted, and almost 800 doctors are now certified to use the device, according to Andrea Argenbright of Ciba.
According to one of the Ex-Press’s developers, Prof. Michael Belkin, implantation of the shunt is rapid, and usually takes less than 5 minutes. “It involves minimal tissue manipulation,” he said. “The insertion procedure is simple, less traumatic than conventional filtering surgery, and is reproducible.”
Belkin is the director of the Ophthalmic Technologies Laboratory at the Goldschleger Eye Research Institute at the Sackler School of Medicine, Tel Aviv University and at Tel Hashomer Hospital. “The Ex-Press is devised to replace conventional glaucoma surgery, not to be used as a last-ditch surgery as the large glaucoma drainage devices are,” he said.
“The procedure provides improvement of patient quality of life through drastic reduction of medical treatment,” Belkin said. “While previous shunts often fail to establish a permanent filtration at the limbus, we believe that the efficacy of the device can be explained by its precise design adaptation to the anatomy of the limbus [plate, spur, the completely inert material], and the minimal tissue trauma associated with the implantation procedure.”
The 3-mm long, 400 micron diameter implant has received both Food and Drug Administration approval and CE approval for marketing in Europe. Before its introduction into the US market, the device had been implanted in more than 1,200 human patients since 1997 in worldwide clinical trials and in commercial use in Europe
In May, the American-Israel Chamber of Commerce, Southeast Region awarded Ciba Vision its Eagle Star Award for ‘Deal of the Year’ “in recognition of their business relationship with Israel-based Optonol, bringing Optonol’s proprietary miniature shunt to glaucoma patients in Canada and the United States.”