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.
|SOURCE Spectranetics Corporation|
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