The patient enrolled in the trial is a 72-year-old female suffering from severe, life-style limiting claudication. The artery treated was 6 millimeters in diameter and was 85% stenosed (blocked) prior to the procedure. Following multiple passes with the TURBO-Booster device, the stenosis was reduced to 25%. The results of the procedure were sufficient for a stand-alone case result that did not require further adjunctive treatment with other devices.
"The Spectranetics TURBO-Booster opens the realm of vessel treatment to include vessels much larger than those treated by existing laser technology, and has the potential to treat every vessel from the groin to the toes using the laser," said David Allie, M.D., a CELLO investigator at Southwest Medical Center in Lafayette, Louisiana.
John G. Schulte, Spectranetics' president and chief executive officer, stated, "I am pleased that we have begun enrollment in the CELLO trial, particularly with the excellent clinical outcome for this patient. The TURBO-Booster product is designed to facilitate laser ablation of larger diameter arteries above the knee, such as the superficial femoral artery. Since we believe that above-the-knee procedures represent nearly 70 percent of all endovascular procedures performed in the legs, our market opportunity is significantly expanded if the CELLO trial is successfully completed and the TURBO-Booster receives FDA clearance."
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® 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 CVX-300 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
Source: Spectranetics Corporation
