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iScience Interventional has received expanded 510(k) clearance from the FDA to allow ophthalmic surgeons to use its microcatheters to enlarge outflow passages to reduce IOP in the treatment of primary open-angle glaucoma.
Menlo Park, CA-iScience Interventional has received expanded 510(k) clearance from the FDA to allow ophthalmic surgeons to use its microcatheters to enlarge outflow passages to reduce IOP in the treatment of primary open-angle glaucoma (POAG).
Canaloplasty has been performed worldwide for more than 3 years.
"Canaloplasty strengthens the ophthalmologists' options for patients with POAG," said Richard A. Lewis, MD, in private practice in Sacramento, CA. "Ophthalmologists have recognized for decades that the ideal solution to glaucoma would restore or maintain the eye's natural drainage system. The canaloplasty does just that."
Michael Nash, president of iScience Interventional, said, "Microcatheters represent an exciting new frontier for ophthalmology. We believe that interventional procedures will significantly alter the treatment paradigm for a wide range of eye diseases and disorders in the future."