Sep 18 2008
SOLX, Inc. announced today U.S. Food and Drug (FDA) 510(k) clearance for the SOLX 790 to perform Titanium:Sapphire laser trabeculoplasty (TLT). The 510(k) clearance was based on the results of a multi-center, international clinical trial that established equivalency of TLT to ALT in the ability to reduce intraocular pressure (IOP) in patients having primary open angle glaucoma and poorly controlled IOP on maximally tolerated medications and/or prior failed trabeculoplasty. The laser had previously been approved for sale in Europe and Canada.
"This is a significant milestone for SOLX," said Doug Adams, President and Founder of SOLX, "The SOLX 790 laser is the cornerstone of our glaucoma management system along with the SOLX Gold Shunt."
More than 180 patients were randomized 1 to 1 for either ALT or TLT in the trial which was conducted across the United States, Europe, Canada, and Israel. The study results showed that in patients at 12 month follow-up, the mean IOP reduction achieved was 6.8 +/- 4.7 mmHg (25.8%) for TLT vs. 5.7 +/- 4.8 mmHg (22.2%) for ALT.
"Patients treated with the SOLX 790 laser achieved an immediate reduction in IOP which was maintained at clinically beneficial levels throughout the study," said Francisco Fantes, M.D., Bascom Palmer Eye Institute, Miami, Florida, and Medical Monitor for the trial. "TLT does so without causing significant thermal damage to the treated tissues which provides glaucoma specialists with an important new tool for managing this disease."
The SOLX 790 Titanium:Sapphire laser emits pulses of energy at a near-infrared 790 nm wavelength to loosen particles in the trabecular meshwork without causing significant thermal damage. The energy penetrates deeper into the tissue than other currently used trabeculoplasty lasers, which may lead to longer lasting treatment benefits.