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The PATENT trial is a prospective registry of 100 patients at up to 10sites in Germany. The trial will assess patency as measured by duplexultrasound at various intervals up to 12 months following the procedure. Itwill also assess safety as measured by adverse events up to 12 monthsfollowing the procedure. In the initial procedure performed at the LeipzigHeart Center, four focal lesions were treated successfully with theTURBO-Booster and TURBO elite 2.0mm catheter in a 20cm long stentedsuperficial femoral artery.
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"The initial result from this Spectranetics device looks very promising,as the new features allow for ablation of more tissue in larger vessels," saidAndrej Schmidt, M.D., of the University of Leipzig-Heart Center. "Instentrestenosis in a superficial femoral artery represents one of the mostchallenging procedures in our practice. The current standard of care, such asrepeat balloon angioplasty, does not have good results as these lesions tendto reoccur. We are very excited with the start of this study in Germany, andwe look forward to examining the mid- and long-term results of this newtherapy."
John G. Schulte, Spectranetics' President and Chief Executive Officer,commented, "We are very pleased to have begun this trial at one of Europe'smost prestigious medical centers. We believe that instent restenosis in thesuperficial femoral artery may represent 25% to 35% of all above-the-kneeprocedures, and there is currently not a good solution for this challenginglesion subset."
About Spectranetics
Founded in 1984, Spectranetics manufactures and sells the only excimerlaser approved in the United States, Europe and Japan for use in minimallyinvasive cardiovascular procedures. This technology treats complexcardiovascular conditions by photo-ablating multiple lesion types into tinyparticles that are easily absorbed into the blood stream. The Company'sdisposable catheters use high-energy "cool" ultraviolet light to vaporizearterial blockages in the legs and heart, as well as scar tissue encapsulatingpacing and defibrillation leads. For more information visithttp://www.spectranetics.com.
Safe Harbor Statement
This news release contains forward-looking statements within the meaningof Section 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934. Such statements are based on current assumptions thatinvolve risks and uncertainties that could cause actual outcomes and resultsto differ materially. These risks and uncertainties may include increasingprice and product competition, increased pressure on expense levels resultingfrom expanded marketing and clinical activities, uncertain success of theCompany's strategic direction, dependence on new product development,intellectual property claims of third parties, availability of inventory fromsuppliers, the receipt of FDA approval to market new products or applicationsand the timeliness of any approvals, the potential size of marketopportunities associated with new products, market acceptance of new productsor applications, product defects, unexpected delays or costs associated withthe Company's relocation and consolidation of its headquarters andmanufacturing operations, price volatility due to the initiation or cessationof coverage, or changes in ratings, by securities analysts. For a further listand description of such risks and uncertainties that could cause the actualresults, performance or achievements of the Company to be materially differentfrom any anticipated results, performance or achievements, please see theCompany's previously filed SEC reports. Spectranetic
