Healthcare Industry News: Peripheral Stent
News Release - September 27, 2006
Medtronic Achieves Key Milestones in Rapidly Growing Peripheral Vascular BusinessCarotid Solutions PMA Filed; Two New Stents Commercially Launched
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced that it has achieved several key product development milestones in its rapidly growing Peripheral vascular business. These milestones include submission of the first Carotid Solution Pre-Market Approval (PMA) module to the U.S. Food and Drug Administration, and CE Mark for two key stent products - the Medtronic Complete SE iliac stent and the Medtronic Racer RX renal stent. Medtronic made the announcement today at the fourth annual VIVA(TM) 06 medical meeting in Las Vegas.
Peripheral vascular disease (PVD) affects more than 12 million people in the U.S., or one in 15 adults. This condition is particularly prevalent in people over age 50 and is often ignored or characterized as a symptom of aging. Through The Medtronic Foundation, Medtronic is a supporter of a national coalition to raise awareness of PVD among those at highest risk and many of the company's products are specifically designed to address this increasing medical problem.
"We are on the cusp of tremendous expansion in the treatment of peripheral vascular disease," said Scott Ward, president of the Vascular business at Medtronic. "Carotid stenting is one of the next great medical frontiers, and treatment of carotid artery disease, stroke and other peripheral-related conditions is expected to grow rapidly during the next five years. Medtronic is well positioned to be a leader in the treatment of these diseases, with a full portfolio of minimally-invasive treatment options that will transform patient care."
Carotid PMA Filing
In early September, Medtronic filed the first of three modules that will comprise its PMA application for FDA approval of the Carotid Solution system. This system is used for the treatment of carotid artery disease and prevention of stroke, which is the third leading cause of death in the U.S. Carotid stenting offers a minimally-invasive alternative to endarterectomy, the current surgical standard of care for patients at risk for stroke due to carotid artery disease.
The Medtronic Carotid Solution includes the Exponent® Stent and the GuardWire® Temporary Occlusion and Aspiration System. The Exponent stent is a tiny metal scaffold that is used to prop open a blocked artery and restore blood flow to the brain. The GuardWire is a distal protection system that uses a balloon to block, or occlude, dangerous debris from reaching the brain or other parts of the body during vascular interventions.
The Medtronic Carotid Solution was launched outside the United States earlier this year with the CE Mark of the Exponent® RX stent and Interceptor® PLUS filter system. The Interceptor PLUS filter is a miniature mesh basket that allows blood to flow normally while it traps loose particles in the bloodstream and prevents them from reaching the brain. Final PMA submission for the Exponent RX stent is expected in early 2007, with U.S. approval anticipated later in the year.
Medtronic received CE Mark for the Complete SE (self-expanding) stent in early September and has launched the product in Europe and other countries around the world. Outside the U.S., Complete SE is intended for the treatment of iliac arteries that deliver blood flow to the lower extremities. Complete is not yet approved in the U.S.
The Complete SE stent system is designed to provide best-in-class precision and deployment accuracy. Based on a mix of proven and new technologies, it is Medtronic's most recent Peripheral Stent to use Nitinol, a super-elastic compound that provides strength along with excellent flexibility and kink resistance. The system's triaxial design includes an inner shaft, a retractable sheath and a patented stabilizing sheath that reduces friction during deployment to help ensure accuracy.
Complete SE offers an expanded size matrix, with diameters as small as 4 mm and longer lengths (from 20-150 mm). All sizes are 6F sheath compatible.
The Racer RX renal stent system also received CE Mark in September. It has been available in Europe with an over-the-wire (OTW) delivery platform since 2003 and was the first cobalt-alloy stent approved for peripheral applications. Racer RX incorporates the single operator Rapid Exchange delivery system, which is the preferred delivery system in Europe and other international markets.
Stents such as Racer RX are designed to maintain proper blood flow in the renal arteries, which branch out from the aorta and supply blood to the kidneys. If left untreated, renal stenosis (blockages) can lead to serious medical complications such as hypertension or kidney failure. Racer RX is specifically designed to improve renal blood flow and, with its exclusive modular design, physicians no longer have to make a choice between strength and flexibility when looking for the best treatment option for renal stenosis. Racer RX offers an advanced cobalt-chromium alloy for superior radial strength compared to stainless steel stents, but also has thin struts for ease of deliverability. This leads to an ideal balance of strength and post-deployment flexibility.
Racer RX is available in diameters from 4 to 7 mm and stent lengths of 12 and 18 mm. It has a low crossing profile and true 0.014-inch guidewire compatibility. Medtronic's "Renal Solution" package for stenting procedures also includes the Launcher® and Sherpa guide catheters and the Thunder extra support wire. Racer RX is expected to launch in Europe and in other international markets within the next two to three months.
Broad Product Portfolio To Meet Physician Needs
Peripheral vascular disease represents a growing medical challenge worldwide for physicians who battle to prevent stroke, loss of limbs or other debilitating conditions in their patients. As many as 20 percent of all people ages 65 and older may suffer from some form of PVD, which is commonly the result of atherosclerosis or "hardening of the arteries" due to the buildup of plaque inside the arteries.
Products like the new Complete SE and Racer RX stents, along with Medtronic's Carotid Solution, expand the company's broad portfolio of minimally-invasive products designed to improve patient outcomes. Other key Medtronic products already approved outside the U.S. for the treatment of peripheral vascular disease include the Aurora self-expanding stent, the Assurant balloon expandable stent and the innovative Pioneer catheter, which is used to facilitate the placement and positioning of catheters and guide wires when crossing challenging lesions.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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