Healthcare Industry News:  nitinol stent 

Devices Interventional

 News Release - May 5, 2009

Spectranetics Makes Pre-IDE Submission to FDA for the Treatment of In-Stent Restenosis in the Legs

COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics Corporation (Nasdaq:SPNC ) today announced that it has made a pre-IDE (Investigational Device Exemption) submission to the Food and Drug Administration regarding the use of laser ablation to treat in-stent restenosis (ISR) in the legs. ISR is caused by the re-growth of tissue within the stent, known as neointimal hyperplasia, which can lead to blockages in the affected leg artery.

The pre-IDE submission makes reference to the results of bench testing associated with the interaction of laser and nitinol stents, which was previously announced in a September 15, 2008 press release. This testing shows that stents subjected to extensive fatigue testing following laser interaction had no fatigue-related failures. The submission also includes reference to clinical data supporting the safety and efficacy of excimer laser treatment in coronary artery ISR and an analysis of interim data from the peripheral artery ISR study PATENT, which is ongoing in Germany. Although the data from the PATENT trial is preliminary, no evidence of stent damage has been observed during the procedure or during subsequent follow-up evaluations. Additionally, the application of laser energy in ablating neointimal hyperplasia within restenosed stents has been successful in the PATENT trial. To date, the percent diameter stenosis pre-treatment has been reduced from a mean of 87% to 30% post laser in 39 subjects. The final residual stenosis after all treatment is 7%.

“We believe that the data we are submitting to FDA supports the safety and efficacy of laser ablation within nitinol stents,” said Emile Geisenheimer, Chairman, President and Chief Executive Officer. “ISR remains a significant unmet need and, to our knowledge, no medical device today is specifically cleared or approved by the FDA for the treatment of ISR in the legs. We believe there are nearly 150,000 stents implanted annually above the knee, and clinical literature cites restenosis rates twelve months following the procedure ranging from 11% to 79%. Our objective through this submission is to determine what, if any, remaining steps may be required for FDA to grant clearance to market our laser ablation products so that we can work to address this unmet need.”

Spectranetics also said that in collaboration with VIVA Physicians, Inc., the decision has been made to terminate the SALVAGE trial. Since this trial was not designed to result in FDA clearance, termination does not impact the objective of obtaining FDA clearance for the use of laser ablation to treat ISR.

“Spectranetics values the opportunity to collaborate with other industry leaders on SALVAGE and appreciates the effort of all in this trial. It is important, however, that we focus our clinical trial efforts on trials directed toward FDA clearance or approval,” concluded Mr. Geisenheimer.

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.

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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.

Source: Spectranetics

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