The iStent made by Glaukos Corp., a California medical device firm, is a titanium tube that can help drain excess fluid that builds up pressure inside the eye. Intraocular pressure has the potential to damage the optic nerve.
Patients with mild or moderate open-angle glaucoma, and who have a cataract in one or both eyes, typically use medications to control the amount of pressure building up. Open-angle glaucoma is the loss of peripheral vision and is the most common form of glaucoma.
In clinical trials, the iStent proved to be more effective in reducing pressure without any use of pressure-lowering drugs compared to those who underwent cataract surgery alone.
In the announcement, the FDA noted that the iStent offers an early intervention for patients compared with other surgical procedures.
“The iStent is a new option that may be considered in the treatment of open-angle glaucoma in patients needing cataract extraction,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, in a news release. “This option may be considered earlier in the disease process than some other types of surgical glaucoma treatments.”
A call to Jeff Wells, Glaukos Corp.’s senior vice president of regulatory and quality affairs, was not returned.
The company has raised more than $90 million since 2002, according to regulatory filings.
There is another device that helps in minimally invasive glaucoma surgery since 1996. According to Amarjit S. Jowandha, Senior Director, RA & QA of NeoMedix Corporation, the intended use of the Trabectome® System is to treat infantile, juvenile and adult glaucoma patients with the niche and patented procedure. The safety and effectiveness profiles of the Trabectome® System have been well established.
There is a drainage system that circles the eye and consists of a meshwork (similar to a sponge) that acts as a filter for fluid draining from the eye into tubular vessels that channel the fluid out of the eye.When the “filter” clogs, the pressure in the eye increases and the internal pressure damages the optic nerve causing reduced vision (glaucoma) and eventually blindness.The product is used to treat glaucoma by removing a portion of the clogged meshwork through high frequency ablation but without damaging the underlying drainage channels.The irrigation/aspiration device provides irrigation during surgery and collection of residual fluid and ablated tissue in a collection bag.The removal of a portion of the meshwork allows normal drainage to be re-established resulting in a reduction of pressure within the eye.
This device was invented by Dr. George Baerveldt of the University of California, Irvine and Dr. Roy Chuck of the Montefiore Medical Center and has been developed, manufactured and commercialized for the global market space by the NeoMedix Corporation in Tustin, California.