FDA APPROVES CLIRPATH 2.5 TURBO CATHETER

Medical devicemaker Spectranetics has received FDA 510(k) clearance for its CLiRpath 2.5 Turbo Catheter to treat total occlusions in the superficial femoral artery.

The 2.5 Turbo catheter - the latest in Spectranetics' Cool Laser Revascularization for Peripheral Artery Therapy (CliRpath) product line -- is an excimer laser catheter designed for treating blockages in the peripheral vasculature. The product features several design enhancements compared with the existing 2.5 catheter, including: an increased number of laser fibers creating 30 percent more energy and 60 percent faster penetration rate; a "continuous on" lasing train enabling shorter procedure times and reducing radiation exposure; and a hydrophilic coating to allow for smoother advancement through tight lesions and an easier transition over the aortic bifurcation.

"Our launch of the CLiRpath 2.5 Turbo catheter is underway and is initially focused on the more than 200 current CLiRpath customers," said Spectranetics President and CEO John Schulte, adding that the company is planning further regulatory filings to add "continuous on" capability to all of its CLiRpath catheters.