COLORADO SPRINGS, Colo., March 14 /PRNewswire-FirstCall/ -- Spectranetics Corporation announced today that it has 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 Food and Drug Administration (FDA) agreed that the clinical data from these 61 patients treated with the TURBO-Booster(R) product is sufficient for submission to the FDA for review. The follow-up data is expected to be gathered early in the second quarter of 2007 and the 510(k) application is currently expected to be filed with the FDA later in the second quarter of 2007.
The TURBO-Booster is a deflecting sheath that facilitates treatment of blockages in the superficial femoral artery (SFA), which is the main artery above the knee, and is used with Spectranetics’ existing TURBO elite(R) laser catheters. The CELLO trial was initiated in July 2006 and enrolled patients with blockages above the knee ranging in length from 1 centimeter to 15 centimeters. The primary endpoint of the trial included angiographic core lab measurements of the percent reduction in diameter stenosis (blockage) following laser treatment. Additional clinical endpoints included 30-day patency using core lab evaluated duplex ultrasound, improvements in ankle-brachial index, and walking impairment improvement at 30 days post-procedure.
“Completion of the CELLO trial has been our top priority since the trial began nine months ago and we are pleased that we have concluded enrollment in the trial ahead of our own expectations,” said John G. Schulte, Spectranetics’ president and chief executive officer. “We believe that approximately two-thirds of the estimated 400,000 endovascular procedures performed annually in the United States are performed on above-the knee blockages, and we look forward to the opportunity to participate in this large and growing market segment. We will now turn our attention to efficiently gathering and analyzing all of the clinical data from the CELLO trial for our pending submission to the FDA.”
About Spectranetics
Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Excimer laser technology delivers relatively cool ultraviolet energy to ablate or remove arterial blockages including plaque, calcium and thrombus. We believe our CVX-300(R) excimer laser is the only system approved in the United States, Europe, Japan, and Canada for use in multiple, minimally invasive cardiovascular procedures. These procedures include atherectomy, which is a procedure to remove arterial blockages in the peripheral or coronary vasculature, and the removal of infected, defective or abandoned cardiac lead wires from patients with pacemakers or implantable cardiac defibrillators, or ICDs, which are electronic devices that regulate the heartbeat.
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: Spectranetics Corporation Guy Childs, Chief Financial Officer (719) 633-8333 www.spectranetics.com INVESTOR & MEDIA CONTACTS: Lippert/Heilshorn & Associates, Inc. Bruce Voss Don Markley (310) 691-7100 www.lhai.com
Spectranetics Corporation
CONTACT: 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/
