It’s for patients with aniridia or other damage to the eye.

The U.S. Food and Drug Administration approved the first stand-alone prosthetic iris in the U.S., a surgically implanted device to treat adults and children whose iris is missing or damaged due to a congenital condition called aniridia or other damage to the eye.

The FDA granted approval of the CustomFlex Artificial Iris to Clinical Research Consultants Inc.

“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said Dr. Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

The CustomFlex Artificial Iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual patient. A surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments. The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures.

 

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The safety and effectiveness of the CustomFlex Artificial Iris was demonstrated primarily in a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects. The study measured patients’ self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis. More than 70 percent of patients reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure. In addition, 94 percent of patients were satisfied with the artificial iris’ appearance.

The study found low rates of adverse events associated with the device or the surgical procedure. In the study, complications associated with the use of the CustomFlex Artificial Iris device included: device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, inflammation of the iris (iritis), adhesion of the iris to the cornea or lens (synechiae) and the need for secondary surgery to reposition, remove or replace the device. Complications associated with the surgical procedure included: increased intraocular pressure, blood leakage in the eye, swelling of the center of the retina (cystoid macular edema), secondary surgery, corneal swelling, iritis, and retinal detachment.

The CustomFlex Artificial Iris should not be used in eyes with any of the following conditions: uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris (rubeosis), certain kinds of damaged blood vessels in the retina, and intraocular infections. It also should not be used in patients who are pregnant.

The CustomFlex Artificial Iris was approved through a premarket approval application, which is the most stringent type of device marketing application and generally required for high-risk devices. CustomFlex Artificial Iris was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

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