Spectranetics Corporation’ Full CLiRpath Product Line Receives FDA Clearance For 80Hz Lasing Capability

COLORADO SPRINGS, Colo., Nov. 1 /PRNewswire-FirstCall/ -- Spectranetics Corporation announced today it has received 510(k) clearance from the Food and Drug Administration for incorporating 80 Hz lasing capability into the Company’s entire CLiRpath(R) product line. This added feature will allow physicians to increase the laser repetition rate (laser pulses per second) up to 80 Hz for more efficient ablation of arterial blockages. Currently only the smallest CLiRpath catheter (0.9mm) has the capability of lasing at 80 Hz, while all other CLiRpath catheters (1.4mm - 2.5mm) have a maximum lasing parameter of 40 Hz.

“Our testing indicates that doubling the repetition rate to 80 Hz results in more efficient ablation, especially in tougher lesions that often contain fibrotic or calcified tissue. Since the 80 Hz feature increases the speed at which tissue is ablated, we believe it will lead to faster procedure times,” stated John G. Schulte, Spectranetics President and Chief Executive Officer. “Our smallest laser catheter, which is 0.9mm in diameter, already incorporates 80 Hz capability and has demonstrated its usefulness in crossing calcified and balloon-resistant lesions in the setting of the coronary arteries. A peer-reviewed article published last year that examined our 0.9mm X-80 catheter for the treatment of highly complex, calcified, and balloon-resistant coronary lesions showed a 92% crossing success rate with this catheter. Given this high success rate in this challenging lesion subset, we believe that incorporating 80 Hz capability into our larger CLiRpath catheters will yield similarly positive results in the treatment of peripheral vascular disease.”

“We plan to immediately begin production of CLiRpath catheters with all three recently cleared enhancements (continuous lasing, hydrophilic coating, and 80 Hz), with a limited product launch in this quarter and a full launch in January,” added Schulte. “I am particularly pleased with the fast FDA response, which came within 35 days of our 510(k) submission. I am encouraged as this will allow our sales team a full 12 months of sales exposure next year with our new CLiRpath Turbo product line.”

About Spectranetics

Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Our CVX-300(R) excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of our FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. In April 2004, we obtained 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries that are not crossable with a guide wire.

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, 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.

Spectranetics, CliRpath and CVX-300 are registered trademarks of The Spectranetics Corporation.

COMPANY CONTACT: INVESTOR & MEDIA CONTACTS: Spectranetics Corporation Lippert/Heilshorn & Associates, Inc. Guy Childs, Chief Financial Officer Bruce Voss (719) 633-8333 Don Markley (310) 691-7100 www.spectranetics.comwww.lhai.com

Spectranetics Corporation

CONTACT: Guy Childs, Chief Financial Officer of Spectranetics Corporation,+1-719-633-8333; or Bruce Voss, or Don Markley both of Lippert/Heilshorn &Associates, Inc., +1-310-691-7100, for Spectranetics Corporation

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