To: Mike who wrote (408 ) 6/4/1999 2:22:00 PM From: Dennis Respond to of 687
MORE GOOD NEWS !!! Medtronic AVE Announces FDA Clearance of the S540 Small Vessel Coronary Stent For Important Segment of U.S. Angioplasty Market PR Newswire - June 04, 1999 11:31 MINNEAPOLIS, June 4 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT), today announced extension of its Medtronic AVE product line into the important U.S. market for small coronary stents. The Medtronic AVE S540 coronary stent system has been cleared for commercial release by the U.S. Food and Drug Administration. The S540 is implanted by interventional cardiologists to facilitate blood flow in heart arteries that measure approximately the diameter of the lead in a standard pencil. The S540 will be available immediately to U.S. physicians for cases of acute or threatened closure during a planned interventional procedure in de novo lesions (less than or equal to 24 mm in length) within a native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2-2.9 mm. Scott Solano, president and chief executive officer of Medtronic's Vascular business, noted that the S540 stent system had been specifically designed for small coronary arteries -- which traditionally have represented approximately 15 percent of coronary stent procedures -- and was not simply a downsized version of stents offered by Medtronic AVE in markets for larger 3.0, 3.5, and 4.0 mm. sizes. "The small-diameter U.S. stent market is increasingly important as cardiologists address serious blockages in a greater portion of the tortuous coronary anatomy," stated Solano. "We believe this to be the broadest approval among similar size devices and we expect cardiologists to quickly recognize the advantages of the new technologies incorporated in the S540. It has come to represent a significant portion of our stent sales in European markets, and we expect it to win rapid acceptance in the United States." The S540 features an average lesion crossing profile of only .039 inch in diameter -- less than 1 mm.-- facilitating delivery across tight lesions. This is the lowest profile of any of Medtronic AVE's stent systems, released to-date in the U.S. The S540 is available in five lengths from 8 mm. to 24 mm., enabling the cardiologist to match its length to the lesion, thus implanting no more metal in the artery than necessary. Crafted with laser-fusion techniques in a unique manufacturing process, the stent offers a highly flexible edgeless design with excellent radial strength. The S540 balloon catheter delivery system which provides a wide working range of inflation pressures from 8 to 14 atmospheres, employs Medtronic AVE's patented stent securement system. Commercially released in Europe just over a month ago, the S540 joins the S670, the GFX2, the GFX and the Medtronic beStent coronary stent systems as integral components of a complete therapeutic system -- including guiding catheters, steerable guidewires, balloon dilatation catheters and other procedure accessories -- for the treatment of coronary artery disease. The S670 and beStent devices are commercially available only outside the United States. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, pioneering device-based therapies that restore health, extend life and alleviate pain. Its Internet address is medtronic.com . Medtronic AVE, formerly Arterial Vascular Engineering, Inc., is headquartered in Santa Rosa, Calif. Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 30, 1998. Actual results may differ materially from anticipated results. SOURCE Medtronic, Inc. /CONTACT: Rachael Scherer, Investor Relations, 612-514-4971, or Jessica Stoltenberg, Public Relations, 612-514-3333, both of Medtronic Inc./ /Company News On-Call: prnewswire.com or fax, 800-758-5804, ext. 551393/ /Web site: medtronic.com