COLORADO SPRINGS, Colo., July 2 /PRNewswire-FirstCall/ -- Spectranetics Corporation today announced it has received clearance from the Food and Drug Administration (FDA) to market its TURBO-Booster(TM) product for the treatment of arterial stenoses and occlusions in the leg, which represents a broader indication for use as compared to current labeling of the existing peripheral laser catheters. The TURBO-Booster functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. The TURBO-Booster combined with Turbo elite(TM) laser catheters allows for removal of large amounts of plaque material within the SFA and popliteal arteries.
The CELLO trial, the study conducted to provide data to FDA in support of the 510(k) premarket notifications for the TURBO-Booster clearance, is a prospective registry that enrolled 61 patients at 16 centers in the United States. The trial included patients with stenoses and occlusions that were greater than or equal to 70% and less than or equal to 100% of the vessel lumen within arteries four to seven millimeters in diameter. Three independent core labs analyzed the angiographic, intravascular ultrasound, and duplex ultrasound data from the trial. The primary endpoints of the trial were the achievement of a minimum 20% reduction in the percent diameter stenosis post-laser compared to pre-intervention and major adverse events. The reduction in percent diameter stenosis following the use of the TURBO-Booster was 35% and there were no major adverse events reported through 30 days following the procedure. As a result, the primary endpoints were met. Further data included in the FDA submission showed a significant improvement in Rutherford scores and health assessment questionnaires at 30-days compared to pre-procedure.
“We are very pleased with the clinical data from the CELLO trial, and the subsequent positive response from the FDA, which places our TURBO-Booster program well ahead of the original timeline. TURBO-Booster significantly expands our addressable market, as we believe approximately two-thirds of all endovascular procedures in the legs are in the larger diameter arteries above the knee,” said John G. Schulte, Spectranetics’ President and Chief Executive Officer. “Our current plan is to immediately begin a controlled release of the product to specified accounts over the next 30 days, which will allow for collection of valuable feedback to help guide our training and marketing programs. We expect to complete the initial launch to our atherectomy account base of approximately 350 accounts within a period of four to five months. After completion of the initial phase of the launch and receiving clinical and marketing feedback regarding the performance of the TURBO-Booster, we will update our annual financial guidance, which we expect to occur during our investor conference call discussing third quarter financial results in late October.”
The Company plans to initiate two clinical trials in 2007, one in the United States and one in Europe, to assess the effectiveness of the TURBO-Booster and existing peripheral atherectomy products for the treatment of in-stent restenosis.
About Spectranetics
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 (719) 633-8333 Don Markley http://www.spectranetics.com (310) 691-7100 http://www.lhai.com MEDIA RELATIONS CONTACT: Schwartz Communications, Inc. Allison Bedard/Julia Maslen (781) 684-0770 spectranetics@schwartz-pr.com
Spectranetics Corporation
CONTACT: Guy Childs, Chief Financial Officer of Spectranetics Corporation,+1-719-633-8333; investor relations, Bruce Voss or Don Markley ofLippert|Heilshorn & Associates, Inc., +1-310-691-7100, or media relations,Allison Bedard or Julia Maslen of Schwartz Communications, Inc.,+1-781-684-0770, spectranetics@schwartz-pr.com, all for SpectraneticsCorporation
Web site: http://www.spectranetics.com/
