Health & Fitness
Health and Fitness
Health and Fitness
Thu, June 10, 2010 Spectranetics Plans Randomized Clinical Trial for In-Stent Restenosis
COLORADO SPRINGS, Colo.--([ BUSINESS WIRE ])--The Spectranetics Corporation (Nasdaq: SPNC) today announced its clinical trial plans related to the treatment of in-stent restenosis (ISR) in arteries above the knee, which remains a major unsolved medical problem. There is no device currently cleared or approved by the FDA to treat ISR.
"Our clinical trial program for ISR is robust and demonstrates our commitment to evidence-based medicine. We look forward to the results from the trials and will work with the FDA on their approval to begin the randomized trial in the United States as soon as possible."
The Company plans to initiate a multi-center, randomized trial in the United States comparing laser ablation followed by adjunctive balloon angioplasty with balloon angioplasty alone.
"Our physician customers prefer randomized, controlled studies to assist them with their clinical decisions surrounding the treatment of in-stent restenosis. Our planned trial will be designed with that in mind, using our recently FDA-cleared above the knee device, the Turbo-Tandema", as well as our Turbo Elite® laser ablation devices,a said Emile J. Geisenheimer, Spectraneticsa™ Chairman of the Board of Directors, President and Chief Executive Officer. aI anticipate this important randomized trial will require the enrollment of a large number of patients in a substantial number of centers in the U.S.a
A decision whether to continue enrollments in the PATENT clinical trial, which was originally designed as a feasibility trial, will be made once the FDA has completed their review of the Companya™s pre-IDE submission for the randomized clinical trial in the U.S. Until then, enrollments will continue in PATENT, which currently has 66 patients enrolled in five centers in Germany. The Company intends to pursue publication of the data from the PATENT trial.
The Company also plans to support a pilot study evaluating the use of laser ablation followed by a paclitaxel-coated angioplasty balloon (PTX PTA) compared with the use of PTX PTA alone in the treatment of in-stent lesions in above-the-knee arteries. The planned enrollment for the PHOTOPAC trial is 50 patients, which will be followed for up to one year following the procedure. Spectraneticsa™ support of the PHOTOPAC trial will be in the form of an unrestricted research grant.
Mr. Geisenheimer concluded, aOur clinical trial program for ISR is robust and demonstrates our commitment to evidence-based medicine. We look forward to the results from the trials and will work with the FDA on their approval to begin the randomized trial in the United States as soon as possible.a
About Spectranetics
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Companya™s products are sold in 40 countries throughout the world and are used to treat arterial blockages in the heart and legs as well as the removal of problematic pacemaker and defibrillator leads.
The Companya™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 and thrombectomy 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 problematic 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 securities litigation or the stockholder derivative litigation in which the Company or any of its officers or directors is a party, insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with these proceedings, adverse impact to our business of the recently enacted healthcare reform bill and related legislation, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital and has rendered our investments in auction rate securities illiquid, 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, adverse outcome of FDA inspections, 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 Companya™s relocation and consolidation of its 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.
