FDA clears Second Sight IDE trial of next-gen Orion cortical visual prosthesis

Second Sight Medical (NSDQ:EYES) said today it won FDA investigational device exemption to initiate a feasibility clinical study of its Orion cortical visual prosthesis system. The conditional approval gives the Sylmar, Calif.-based company clearance to enroll up to 5 patients at 2 US sites, but requires that the company conduct additional device testing and “address outstanding questions” within 45 days, it said. “This is an exciting milestone for the company given the potential of Orion to provide useful vision to millions of blind individuals worldwide who have no other option today. We are delighted to have received conditional approval from the FDA to move forward and can now focus on finalizing the various approvals and agreements required at each clinical trial site. Once we complete those steps, our designated U.S. clinical trial sites, the University of California at Los Angeles and Baylor College of Medicine in Houston, can begin patient recruitment efforts. The Orion team has met all major internal milestones this year and we remain on-track to achieve the Company’s stated goal of implanting our first Orion patient before year end,” prez & CEO Will McGuire said in a prepared statement. The Orion cortical visual prosthesis system is designed to convert images captured by a miniature video camera, mounted on a patient’s glasses, into a series of electrical pulses which are transmitted wirelessly to an array of electrodes on the su...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Optical/Ophthalmic Prosthetics second-sight-medical Source Type: news