Healthcare Industry News:  peripheral artery disease 

Devices Interventional FDA

 News Release - July 12, 2007

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 (HSMN NewsFeed) -- 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

Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include increasing price and product competition, increased pressure on expense levels resulting from expanded marketing and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, the potential size of market opportunities associated with new products, market acceptance of new products or applications, product defects, unexpected delays or costs associated with the Company's relocation and consolidation of its headquarters and manufacturing operations, price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Spectranetics

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