Healthcare Industry News:  peripheral artery disease 

Devices Interventional

 News Release - April 7, 2011

Spectranetics to Initiate Landmark Randomized Study of Laser Treatment for Peripheral Artery Disease

COLORADO SPRINGS, Colo.--(Healthcare Sales & Marketing Network)-- Spectranetics Corporation (Nasdaq:SPNC ) today announced that it plans to initiate the EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) clinical trial following the recent conditional approval of the Company’s investigational device exemption (IDE) application by the Food and Drug Administration (FDA). The study will compare the safety and efficacy of excimer laser atherectomy utilizing the Spectranetics’ Turbo-Tandem and Turbo Elite products in conjunction with balloon angioplasty, with that of balloon angioplasty alone in a 2:1 fashion on patients with femoropopliteal in-stent restenosis (ISR), a condition caused by the development of scar tissue within a previously implanted stent.

EXCITE ISR will enroll up to 353 patients at up to 30 sites in the U.S., with first patient enrollment expected within 30 days. The primary safety endpoint will measure major adverse events defined as death, major target limb amputation and target lesion revascularization (TLR) through 30 days following the procedure. The trial’s primary efficacy endpoint is freedom from clinically-driven TLR (re-intervention), which will be evaluated at six months following the procedure. These results will be included in a 510k filing with the FDA. The study will employ three separate independent core laboratories and an independent Data Safety and Monitoring Board.

“We are very pleased to be able to start the EXCITE ISR trial and plan to enroll the first patient within the next 30 days,” stated Shar Matin, Senior Vice President of Operations, Product Development and International. “There is currently no medical device cleared by the FDA to treat patients with ISR. Spectranetics is proud to be on the leading edge of clinical research to evaluate laser atherectomy for the treatment of peripheral artery disease.”

Dr. Eric Dippel, the National Principal Investigator for the EXCITE ISR trial and interventional cardiologist at Trinity Regional Health System in Bettendorf, Iowa, commented, “Effective treatment for in-stent restenosis in upper leg interventions has yet to be proven in a scientifically rigorous randomized trial. The intent of this trial is to provide evidence for laser atherectomy in this difficult patient population, and I am looking forward to initiating this landmark clinical trial.”

About Peripheral Arterial Disease

Peripheral Arterial Disease (PAD) is a serious cardiovascular condition that causes arteries in the legs to become restricted or completely blocked. An estimated 10 million Americans experience this condition, with up to 50% showing no symptoms and only 10% having the classic symptom of claudication. Those suffering from PAD are at increased risk for heart disease, aortic aneurysms, stroke and death. Treatments for PAD include exercise programs, medications, and minimally invasive endovascular procedures or surgery to open the obstruction. Common endovascular procedures include laser atherectomy, balloon angioplasty, and stenting, among others.

About In-Stent Restenosis

A frequent complication of stenting is re-narrowing of the artery or in-stent restenosis (ISR). ISR is caused by the body’s response to the stent implantation, resulting in excessive scar tissue formation extending into the opening of the artery. Depending on the stent type, location, size, and number of stents implanted, ISR occurs in 18% to 50% of patients in the first year. The re-narrowing may become so significant as to require additional procedures. Evidence also shows that patients who experience ISR are more likely to experience it in the future even after an additional procedure. Spectranetics estimates that over 125,000 ISR procedures will be performed in 2013.

About Spectranetics

Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company’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 pacemaker and defibrillator leads.

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 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 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 insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with legal proceedings, including legal proceedings in which the Company may have an indemnification obligation, 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, 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 Company'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.


Source: Spectranetics

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