Research using the InnFocus MiroShunt to reduce the eye pressure in patients with Glaucoma. The first Phase of FDA clinical trials where held in 12 centers in the United States and the final Phase to be this year. – MDA
MIAMI, Jan. 20, 2015 /PRNewswire/ — InnFocus, Inc. reports that the first surgeries using the InnFocus MicroShunt® glaucoma drainage implant in Spain have been successfully conducted. Two surgeries were performed at the Hospital Clinico San Carlos in Madrid, Spain.
“The surgeries went very well and the patients are showing good results,” said Prof. Dr. Julian Garcia Feijoo who performed the surgeries in Madrid. “We believe that the InnFocus MicroShunt®, and its less invasive way to treat glaucoma, will help patients around the world.”
The InnFocus MicroShunt® is a safe, effective, sustainable, and easy-to-perform alternative for the surgical treatment for early stage to late stage glaucoma, which affects over 78 million people worldwide.
The Company says it expects to have treated approximately 150 glaucoma patients by early 2015. The device is in Phase 1 Food and Drug Administration (FDA) trials at 12 centers in the United States, and expects to begin the final FDA phase in 2015. Patients have also been treated with the InnFocus MicroShunt® in France, Japan, and the Dominican Republic.
The Company recently reported results for up to three years on 79 glaucoma patients treated outside the U.S. They have experienced a mean reduction in Intraocular Pressure (IOP) below 14mmHg, which reduces a major risk factor for optic nerve damage and reduction of vision that can occur when IOP levels are too high.
“We are encouraging surgeons to realize they can ‘think low’ with a procedure less invasive than the trabeculectomy,” said Russ Trenary, InnFocus President and CEO. “We are pleased that the world’s glaucoma community is learning more about what we believe is a revolutionary means for significantly reducing IOP and treating glaucoma, without creating a scleral flap.”
The InnFocus MicroShunt® has been implanted alone or in combination with cataract surgery in clinical trials outside the United States. It was developed in collaboration with the University of Miami’s Bascom Palmer Eye Institute. It provides a quick and simple method of shunting aqueous humor from the anterior chamber to a diffused bleb without the use of a scleral flap.
It uses a patented micro-shunt made from the innovative SIBS Material to control flow. The mechanism of action for the MicroShunt® of subconjunctival/Tenons drainage has been the accepted gold standard.
CAUTION: INVESTIGATIONAL DEVICE. LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.
SOURCE InnFocus Inc. & PR Newswire