To: Dennis who wrote (411 ) 11/23/1999 5:41:00 PM From: Mike Read Replies (1) | Respond to of 687
This news is huge. MDT just got the S670 on over the wire technology last week and now this rapid exchange technology is going to help bigtime. Anyone else have comments? Best of luck to all, Mike Medtronic Announces U.S. Introduction of S670 With Discrete Technology(TM)Rapid Exchange Coronary Stent System MINNEAPOLIS, Nov. 23 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT), today announced PMA approval by the U.S. Food and Drug Administration (FDA) of a single-operator exchange version of its recently-released S670 coronary stent system. This technologically advanced stent system is now available on a rapid exchange platform and approved for immediate commercial distribution. Approval of the Medtronic S670 with Discrete Technology(TM) Rapid Exchange Coronary Stent System follows FDA commercial clearance of the Medtronic S670 with Discrete Technology(TM) Over-The-Wire Coronary Stent System, which incorporates the most advanced stent design and delivery system technologies available on the market. The rapid exchange version of the S670 offers the same 0.043 of an inch diameter crossing profile for 3.0 mm and 3.5 mm vessels and 0.044 of an inch in diameter crossing profile for 4.0 mm vessels. Its primary new feature is a delivery catheter especially designed for use by a single operator. This rapid exchange delivery catheter system will allow for perfusion of blood through the guidewire lumen during the stent deployment procedure. "The S670 with Discrete Technology(TM) Rapid Exchange Coronary Stent System is yet another in a line of products to be offered by Medtronic AVE based on intellectual property rights gained in the acquisition of the coronary catheter lab business of C.R. Bard, Inc.," said Scott Solano, president of Medtronic Vascular. "We are committed to offering a full range of products for the variety of cases and procedure styles used by today's interventional cardiologists. The addition of a single-operator version extends the technologies of the S670 stent system into a new arena, making it possible for a wider range of physicians and patients to enjoy the benefits of a system that glides through the vessels like a balloon." The S670 rapid exchange system is the latest in a succession of Medtronic AVE stent systems for use after coronary arteries have been widened with balloon catheters in a therapy known as percutaneous transluminal coronary angioplasty (PTCA). More than 750,000 such procedures take place in the United States each year, and physicians use stents in approximately 70 percent of these cases. The worldwide market for stents is estimated at greater than $2 billion. Both S670 systems incorporate a number of breakthrough technological features to facilitate smooth delivery of the stent while preserving the health of surrounding vessel tissue. These features include: -- Dual Helix Laser Fusion. The S670 is designed to provide optimal lesion scaffolding. It is comprised of shorter, 1.5 mm elements having 14 struts. The stent elements are connected in a new dual helix configuration that is designed to improve the stent's scaffolding properties by reducing the cell size by approximately 35 percent, resulting in a smoother angiographic appearance without compromising the natural vessel curvature. The S670 maintains the rounded edges consistent with Medtronic AVE's modular stent technology. -- Discrete Technology(TM). More intelligent balloon processing provides for precise alignment of the stent within the balloon, thereby minimizing the balloon overhang extending beyond the stent's ends. This, in turn, focuses the deployment force along the stent's length, potentially reducing the likelihood of arterial damage beyond the stent's ends. -- Secure Technology(TM) is a patented system designed to ensure that the stent remains securely attached to the balloon during delivery, positioning and deployment. Created by a combination of heat and pressure, proximal and distal balloon pillows, as well as pillows around and between the stent's struts, encapsulate the struts for added security when tracking through tortuous anatomy. Additional security is incorporated into this system by the use of an enlarged proximal pillow. -- AVEd(TM) Balloon Technology is a material that has excellent refolding, uniform expansion, and a rated burst pressure of 16 atmospheres (15 atmospheres for 4.0 mm). The features of this balloon material enable the clinician to easily use the same delivery system for stent deployment and post-stent dilatation. The S670 rapid exchange stent system joins the Medtronic S670 with Discrete Technology Over-The-Wire Coronary Stent System and the earlier GFX2 and S540 stent systems as components of a complete product line for treating cardiovascular disease. Other products include guiding catheters, steerable guidewires, balloon dilatation catheters and accessories for angioplasty procedures. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, specializing in implantable and interventional 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. More information about the new stent is available at s670.com 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 and on Form 10-K for the year ended April 30, 1999. Actual results may differ materially from anticipated results. SOURCE Medtronic, Inc. CO: Medtronic, Inc.; Medtronic AVE ST: Minnesota, California IN: MTC SU: PDT 11/23/1999 15:08 EST prnewswire.com