iScience receives clearance for use of microcatheters for POAG

September 3, 2008

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).

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.”

Bradford J. Shingleton, MD, associate clinical professor of ophthalmology, Harvard Medical School, Boston, added, “The canaloplasty is a procedure that is grounded in high technology and science. Over the past several years, respected researchers in Europe, Canada, and the United States have amassed clinical data that support the safety and efficacy of canaloplasty for patients with POAG as well as the significant reduction of costly medications.”

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.”