Six Month Data Demonstrates Durability of Procedure and Improved Clinical
COLORADO SPRINGS, Colo., Oct. 24 /PRNewswire-FirstCall/ -- Spectranetics Corporation (Nasdaq: SPNC) today announced the presentation of results from its CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) clinical trial, at the nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. The study was a prospective, non-randomized trial designed to provide clinical data on the reduction of arterial blockage in above-the-knee arteries following use of the Spectranetics TURBO-Booster(TM) product for the treatment of peripheral artery disease (PAD). TURBO-Booster received clearance from the Food and Drug Administration (FDA) in July 2007 following the conclusion of the trial, which enrolled 65 patients at 17 hospitals in the United States.
Highlights of the data presented include:
-- Achievement of significant tissue removal, which exceeded the targeted
primary endpoint, measured by angiographic and IVUS core labs;
-- Demonstrated durability of procedure through freedom from target
lesion revascularization in 86% of the patients through six months
following the initial procedure;
-- No major adverse cardiac events reported through six months following
the procedure, which adds to the existing body of clinical evidence
supporting the safety of laser ablation; and
-- Significant improvement in all clinical outcomes measured six months
following the procedure, including Rutherford category, ankle-brachial
Index, and walking impairment.
"The six-month data from the CELLO trial demonstrates the ability of laser ablation facilitated by the TURBO-Booster to safely restore blood flow in the superficial femoral artery and significantly improve clinical outcomes in patients with peripheral arterial disease up to six months following the procedure," said Dr. Rajesh Dave, national principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital. "Many patients suffer unnecessarily from pain in the legs and feet that can drastically impact active lifestyles. The TURBO-Booster represents a viable treatment option for those patients with peripheral arterial disease."
Spectranetics' 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 Spectranetics' Turbo elite(TM) laser catheters allows for removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries.
"With conclusive data on the effectiveness of the TURBO-Booster product, Spectranetics is working with physicians to improve the lives of the millions suffering from blocked arteries above the knee. Our laser ablation system is easy to use and effective at getting patients back on their feet and engaged in active lifestyles, " said John G. Schulte, Spectranetics' president and CEO. "Since receiving FDA clearance in July, several hundred procedures have been performed, with more than 180 accounts placing their initial order and nearly 45 percent of those having already re-ordered. Our limited market release of TURBO-Booster is right on schedule and we plan to complete this initial phase of our market launch in the current quarter."
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 http://www.spectranetics.com.
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.
Media Contacts: Investor Contacts:
Stacey Holifield/Allison Bedard Don Markley/Bruce Voss
Schwartz Communications, Inc. Lippert/Heilshorn & Associates, Inc.
(781) 684-0770 (310) 691-7100
|SOURCE Spectranetics Corporation|
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