COLORADO SPRINGS, Colo., Sept. 26 /PRNewswire-FirstCall/ -- Spectranetics Corporation (Nasdaq: SPNC) today announced it has enrolled the first patient in the PATENT trial utilizing the Company's TURBO elite(TM) laser catheters in combination with the recently FDA cleared TURBO-Booster(TM).
The PATENT trial is a prospective registry of 100 patients at up to 10 sites in Germany. The trial will assess patency as measured by duplex ultrasound at various intervals up to 12 months following the procedure. It will also assess safety as measured by adverse events up to 12 months following the procedure. In the initial procedure performed at the Leipzig Heart Center, four focal lesions were treated successfully with the TURBO-Booster and TURBO elite 2.0mm catheter in a 20cm long stented superficial femoral artery.
"The initial result from this Spectranetics device looks very promising, as the new features allow for ablation of more tissue in larger vessels," said Andrej Schmidt, M.D., of the University of Leipzig-Heart Center. "Instent restenosis in a superficial femoral artery represents one of the most challenging procedures in our practice. The current standard of care, such as repeat balloon angioplasty, does not have good results as these lesions tend to reoccur. We are very excited with the start of this study in Germany, and we look forward to examining the mid- and long-term results of this new therapy."
John G. Schulte, Spectranetics' President and Chief Executive Officer, commented, "We are very pleased to have begun this trial at one of Europe's most prestigious medical centers. We believe that instent restenosis in the superficial femoral artery may represent 25% to 35% of all above-the-knee procedures, and there is currently not a good solution for this challenging lesion subset."
Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The Company's disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads. For more information visit http://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 increasing price and product competition, increased pressure on expense levels resulting from expanded marketing 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, the potential size of market opportunities associated with new products, market acceptance of new products or applications, product defects, unexpected delays or costs associated with the Company's relocation and consolidation of its headquarters and manufacturing operations, 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.
COMPANY CONTACT: INVESTOR RELATIONS CONTACTS
Spectranetics Corporation Lippert/Heilshorn & Associates, Inc.
Guy Childs, Chief Financial Officer Bruce Voss/Don Markley
(719) 633-8333 (310) 691-7100
MEDIA RELATIONS CONTACT:
Schwartz Communications, Inc.
|SOURCE Spectranetics Corporation|
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