Spectranetics receives FDA go ahead to market laser catheters

Jul 13 2007

Spectranetics Corporation has announced it has received clearance from the Food and Drug Administration (FDA) to market its TURBO elite 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.

http://www.spectranetics.com/