COLORADO SPRINGS, Colo., May 19 /PRNewswire-FirstCall/ -- Spectranetics Corporation announced today that its CLiRpath TURBO-Booster product that is designed for the treatment of blockages in the superficial femoral artery (SFA) was featured in a live case session this week at EuroPCR, one of the largest interventional conferences (peripheral and coronary) in the world. The live case was performed at Leipzig Heart Center in Germany and transmitted via satellite to the EuroPCR symposium that was held this week in Paris, France.
Stand-alone results were achieved in two focal instent restenosis lesions after initial treatment with a 2.0 CLiRpath TURBO laser catheter followed by four passes with the TURBO-Booster system. The TURBO-Booster allows for controlled-deflection of the tip of the laser catheter, enabling a larger channel to be created as compared with that created by the laser catheter alone. The live case was performed by Craig Walker, M.D. and Andrej Schmidt, M.D.
Craig Walker, M.D., President and Medical Director of the Cardiovascular Institute of the South in Lafayette, Louisiana, stated, “This was a very extensive instent restenosis in a large artery in the upper leg, which represents one of the most challenging cases as the blockages often contain clot and plaque. The laser and new product system quickly and easily recanalized this lesion, leaving virtually no residual blockage and there was no evidence of any debris to the lower leg.”
Andrej Schmidt, M.D., commented, “The initial result of this new device looks very promising. The new features allow for ablation of more tissue in larger vessels, even in calcified lesions as compared to the previous generation of laser catheters.”
Spectranetics is in the process of initiating the CELLO Study using the Turbo Booster System in the United States. This single-arm study will take place in 10 to 15 centers, and will enroll approximately 100 patients. Spectranetics hopes to obtain device clearance in 2007.
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. Excimer laser technology delivers relatively cool ultraviolet energy to ablate or remove arterial blockages including plaque, calcium and thrombus. We believe our CVX-300(R) excimer laser is the only system approved in the United States, Europe, Japan, and Canada for use in multiple, minimally invasive cardiovascular procedures. These procedures include atherectomy, which is a procedure to remove arterial blockages in the peripheral or coronary vasculature, and the removal of infected, defective or abandoned cardiac lead wires from patients with pacemakers or implantable cardiac defibrillators, or ICDs, which are electronic devices that regulate the heartbeat.
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 and TURBO-Booster are registered trademarks of The Spectranetics Corporation.
COMPANY CONTACT: Spectranetics Corporation Guy Childs, Chief Financial Officer (719) 633-8333 www.spectranetics.com INVESTOR & MEDIA CONTACTS: Lippert/Heilshorn & Associates, Inc. Bruce Voss Don Markley (310) 691-7100 www.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
Web site: http://www.spectranetics.com//
