iScience receives expanded clearance for canaloplasty microcatheter
MENLO PARK, Calif. — iScience Interventional has received expanded 510(k) clearance from the U.S. Food and Drug Administration for its canaloplasty microcatheter, the company announced in a press release. The microcatheter is used for catheterization and viscodilation of Schlemm's canal to reduce IOP in adult patients with primary open-angle glaucoma.
Canaloplasty is a minimally invasive surgical technique that uses a 250-µm microcatheter to access the eye's natural drainage channels to remove fluid from the eye. During the 30-minute procedure, the surgeon inserts a microcatheter through a small incision, expands the main drainage channel and places a small suture within the canal to maintain the opening so it can achieve normal function.
This procedure can rejuvenate the eye's natural drainage system by lowering IOP, the release said.
"Microcatheters represent an exciting new frontier for ophthalmology," Michael Nash, president of iScience Interventional, said in the release. "We believe that interventional procedures will significantly alter the treatment paradigm for a wide range of eye diseases and disorders in the future."