Spectranetics Receives FDA Clearance for Expanded Labeling for TURBO Elite
Entire Catheter Line Now Cleared for Treatment of All Blockages in Leg Arteries
COLORADO SPRINGS, Colo., July 12 / / - Spectranetics Corporation (NASDAQ:SPNC) today announced it has received clearance from the Food and Drug Administration (FDA) to market its TURBO elite(TM) line of laser catheters for the treatment of all stenoses and occlusions within arteries of the leg. The clearance applies to catheters ranging in size from .9 millimeters to 2.5 millimeters. This represents a broader indication for use as compared to previous labeling of the TURBO elite catheters for the treatment of total occlusions that cannot be crossed with a guidewire. The expanded labeling is resulting from the clinical data in the CELLO study.
"This authorization creates significant new opportunities for the standalone TURBO elite in addition to that product's unique capability to treat occlusions not crossable with a guidewire," said John G. Schulte, Spectranetics' President and Chief Executive Officer. "Combined with the recent similar approval for our TURBO-Booster(TM) product, Spectranetics now provides one of the industry's broadest lines of atherectomy products to treat peripheral artery disease."
On July 2, 2007, the Company announced it had received clearance from the FDA to market TURBO-Booster for the treatment of arterial stenoses and occlusions in the leg. TURBO-Booster functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. The TURBO-Booster combined with Turbo elite laser catheters allows for removal of large amounts of plaque material within the SFA and popliteal arteries.
About Spectranetics
Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The Company's disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads. For more information visit www.spectranetics.com/.
Source: Spectranetics Corporation
Web site: www.spectranetics.com/ http://www.lhai.com/
