Health & Fitness
Health and Fitness
Health and Fitness
Wed, January 21, 2009 Spectranetics Reports on 12-Month CELLO Data at LINC Meeting in Leipzig, Germany
COLORADO SPRINGS, Colo.--([ BUSINESS WIRE ])--Spectranetics (NASDAQ:SPNC) announced the 12-month follow-up data from the CELLO study at the Leipzig Interventional Course (LINC) meeting held last week in Leipzig, Germany. The data was presented by Dr. Rajesh Dave, principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, Pennsylvania.
The CELLO study is a prospective, multi-center registry which enrolled 65 patients treated with directed laser ablation of lesions of the superficial femoral arteries and popliteal arteries using the TURBO-Booster device. The primary endpoint of the study, which has been previously reported, was the percentage reduction in the stenosis prior to adjunctive therapy. Prior to treatment, the mean stenosis, or blockage, as measured by an independent core lab, was 77%. The mean stenosis following use of the TURBO-Booster was 42% and 21% after adjunctive therapy, which was either balloon angioplasty or balloon angioplasty and stenting. Stenting was performed in only 23% of the procedures. Of these patients, 86% and 78% were free from a repeat intervention at six and 12 months post-procedure, respectively. Patency as measured by duplex ultrasound was 59% and 54% at six and 12 months post-procedure, respectively. The primary safety endpoint was major adverse cardiac events at six months. No major adverse cardiac events occurred at six months. Measures of functional improvement included change in Rutherford class, walking impairment and ankle-brachial index, which all showed improvement at six months compared to baseline. Improvement was maintained in all three of these functional measures through the 12 month follow-up. All data from the CELLO trial has been submitted by Spectranetics to the Food and Drug Administration, which has accepted the data as part of the process to conclude the study.
Dr. Dave commented, "The data from the CELLO trial validates the strengths of laser atherectomy as demonstrated by an excellent safety profile and high procedural success with 78% of patients free from target lesion revascularization 12 months following the procedure in difficult lesion subsets including the superficial femoral and popliteal arteries."
Emile J. Geisenheimer, Chairman, President and Chief Executive Officer, stated, "I'm particularly pleased with the performance of our TURBO-Booster product as demonstrated in the CELLO 12-month follow-up data, which shows durable procedural success as evidenced by freedom from re-intervention in 78% of the patients treated and clinical success durability as measured by Rutherford score, ankle brachial index and walking impairment. The TURBO-Booster product is an important tool to treat peripheral arterial disease and the clinical success of this device positively impacts the quality of life of patients suffering from this disease that afflicts approximately 8 to 12 million people."
About Spectranetics
Spectranetics manufactures and markets the only Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. More than 800 Spectranetics laser systems are used in hospitals worldwide.
The Company's Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.
The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information visit [ 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 adverse results of the FDA and Immigration and Customs Enforcement investigation, adverse results of the SEC investigation or any securities litigation in which the Company or any of its officers or directors is a party, market acceptance of excimer laser atherectomy technology, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development 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, market acceptance of new products or applications, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with the Company's relocation and consolidation of its headquarters and manufacturing operations, and 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.
