COLORADO SPRINGS, Colo., Feb. 8 /PRNewswire-FirstCall/ -- Spectranetics Corporation announced today that the LACI (Laser Angioplasty for Critical Limb Ischemia) clinical trial results were published in the current issue of the Journal of Endovascular Therapy, a peer-reviewed medical journal. The article is available at www.jevt.org.
The objective of the LACI trial was to evaluate the effectiveness of excimer laser angioplasty in critical limb ischemia patients with complex blockages in their legs. The study population included only those patients who were determined to be poor or non-surgical candidates. As a result, these patients were at high risk for limb loss. The primary endpoint of the trial, limb salvage (avoidance of a major amputation above the level of the ankle) among surviving patients at six months following the initial laser treatment, was 93%.
John R. Laird, M.D., Washington Hospital Center, principal investigator of the LACI trial, commented, “The LACI trial is a landmark trial which demonstrates the efficacy of laser-assisted angioplasty for patients with very severe peripheral arterial disease who are at risk for amputation. There was an excellent limb salvage rate of 93% in this series of patients who were otherwise poor candidates for surgery due to their extensive arterial disease and comorbidities.”
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. Our CVX-300(R) excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of our FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. In April 2004, we obtained 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries that are not crossable with a guide wire.
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
CONTACT: Guy Childs, Chief Financial Officer of Spectranetics Corporation,+1-719-633-8333; or Bruce Voss, or Don Markley, both of Lippert/Heilshorn &Associates, Inc., +1-310-691-7100, for Spectranetics Corporation
