COLORADO SPRINGS, Colo., May 2 /PRNewswire-FirstCall/ -- Spectranetics Corporation today announced it has filed a 510(k) application with the Food and Drug Administration (FDA) for the approval of its TURBO-Booster(R) product.
The TURBO-Booster is a deflecting sheath that facilitates treatment of blockages in the popliteal artery and superficial femoral artery (SFA), which are the main arteries at or above the knee, and is used with Spectranetics' existing peripheral atherectomy laser catheters.
The application includes a full review of data and findings from Spectranetics' recently completed CELLO trial. On March 14, 2007, the Company announced that it had stopped enrolling patients in the CELLO study after enrolling 61 of the planned 85 patients. Based on a review of the preliminary data, Spectranetics and representatives of the FDA agreed that the clinical data from these 61 patients treated with the TURBO-Booster product was sufficient for submission to the FDA for review. The FDA typically responds to 510(k) submissions within 90 days, although a final decision may take longer.
"The TURBO-Booster enables true directional atherectomy with our existing peripheral atherectomy catheters, allowing creation of large lumens. We believe approximately two-thirds of all endovascular procedures in the legs are in the larger diameter arteries above the knee, so this represents a significant market expansion opportunity for Spectranetics," said John G. Schulte, Spectranetics' president and chief executive officer. "We are also excited by the potential for the TURBO-Booster to treat in-stent restenosis (ISR), and we plan to initiate clinical research in 2007 to assess the effectiveness of the TURBO-Booster and existing peripheral atherectomy products for the treatment of ISR."
About Spectranetics
Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in multiple, 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 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, 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.
Spectranetics and CVX-300 are registered trademarks of The Spectranetics Corporation.
COMPANY CONTACT: INVESTOR & MEDIA CONTACTS: Spectranetics Corporation Lippert/Heilshorn & Associates, Inc. Guy Childs, Chief Financial Officer Bruce Voss (719) 633-8333 Don Markley (310) 691-7100 www.spectranetics.comwww.lhai.com
Spectranetics CorporationCONTACT: Guy Childs, Chief Financial Officer of Spectranetics Corporation,+1-719-633-8333; or Investors & Media, Bruce Voss or Don Markley, both ofLippert/Heilshorn & Associates, Inc., +1-310-691-7100, for SpectraneticsCorporation
Web site: http://www.spectranetics.com/
