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Biotech / Medical : Spectranetics (SPNC): Any info? -- Ignore unavailable to you. Want to Upgrade?

To: OFW who wrote (43)	2/16/2000 11:01:00 AM
From: Fuzzy	Read Replies (1) \| Respond to of 60

FDA Grants Spectranetics Clearance to Market Next Generation Laser Catheter For Excimer Laser Coronary Angioplasty PR Newswire - February 16, 2000 10:31 Spectranetics' Vitesse Cos Produces Larger Clearance in Blocked Heart Arteries COLORADO SPRINGS, Colo., Feb. 16 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved The Spectranetics Corporation (Nasdaq: SPNC) Pre-Market Approval Supplement (PMA(S)) to market a new line of single use catheters for laser-based coronary angioplasty procedures. Spectranetics' new Vitesse Cos (OS for "optimally spaced" fibers referring to the optical fibers which transmit the laser energy to the blockage) catheters are designed to achieve greater "debulking" in a blocked coronary artery than the Company's earlier generation catheters. In laboratory testing, the Vitesse Cos improved debulking efficiency -- the dissolving of tissue blocking an artery -- by up to 62% over what has been achieved with earlier generations of catheters. Spectranetics developed the Vitesse Cos using a proprietary engineering process to bundle optical fibers in a novel way. The fibers are utilized to conduct the light pulses from the laser precisely to the tissue blockage under treatment. Said Joseph A. Largey, Spectranetics' President and CEO, "During 1999 we experienced 85% sales growth in our coronary angioplasty line over 1998. Skilled physicians who are trained on our laser technology report to us that they attain outstanding debulking results. We believe that this next generation product -- the Vitesse Cos -- will improve the already superior results that physicians achieve with our excimer laser coronary angioplasty technology." The Company expects to release the product in the second quarter of 2000 in the United States. The Company last year received the CE mark of approval for the Vitesse Cos. That approval covered the products standard six indications as well as allowed Spectranetics to market the device in Europe for the debulking of coronary stents that have become clogged, a condition known as in-stent restenosis. The usage of the Company's catheters in restenosed stents is currently limited to investigational use in the United States. Said Dr. med. Bernward Lauer of the Leipzig Heart Center in Germany, "Coronary laser angioplasty was already a standard tool in our laboratory. The OS catheter increases the effectiveness of laser debulking. We consistently see larger and smoother lumens using the new OS catheters from Spectranetics." Spectranetics is a medical device company engaged in the development, manufacturing, marketing and distribution of its technology for interventional cardiovascular therapy. The Company's CVX-300(R) excimer laser system is the only excimer laser system approved by the FDA for multiple cardiovascular procedures. The technology has been designed for use in multiple cardiovascular applications, including coronary angioplasty and the removal of pacemaker and ICD leads. The Company is also developing additional applications for its excimer laser technology in restenosed stents and peripheral vascular applications. 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 include price and product competition, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, market acceptance of new products, and product defects. For a further list and description of such risks and uncertainties which could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Note: Spectranetics and CVX-300 are registered trademarks of the Spectranetics Corporation. SOURCE Spectranetics Corporation /CONTACT: Paul Samek, CFO of The Spectranetics Corporation, 800-633-0960/