Medtronic Receives CE Mark For New Carotid Stent And Filter
New products provide minimally invasive treatment option to surgery for the prevention of stroke in patients with carotid artery disease
MINNEAPOLIS – April 27, 2006 – Medtronic, Inc. (NYSE: MDT) today announced that it has received CE Mark (Conformité Européene) approval for its next-generation self-expanding carotid stent and filter system, providing patients afflicted by carotid artery disease with a new, minimally-invasive treatment option to surgical procedures for the prevention of stroke. Carotid artery disease (CAD) is the narrowing or blockage of arteries in the neck that supply blood to the brain. Without proper treatment, this condition can lead to stroke (a “brain attack”), which is one of the world’s leading causes of death and long-term disability.
The new Medtronic Exponent® RX Self-Expanding Carotid Stent is a tiny metal scaffold that is used to prop open a blocked artery and restore adequate blood flow. While not yet approved for use in the United States, it is part of the Medtronic Carotid Solution, which also includes the Interceptor™ PLUS Carotid Filter System. This 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 and causing a stroke during the procedure. The Medtronic Carotid Solution also includes additional products that provide alternative methods of removing embolic debris from the bloodstream.
Together, these products provide physicians with a complete selection of tools for the minimally-invasive treatment of CAD. Carotid stenting has become an effective alternative to a procedure called carotid endarterectomy, in which physicians surgically open the carotid artery and remove the fatty buildup of plaque to restore blood flow. Plaque forms in a blood vessel when cholesterol, fat and other substances build up on the artery wall, a process called atherosclerosis. In a minimally-invasive procedure, the physician inserts a thin tube called a catheter into a small incision or puncture made in the arm or groin. The catheter is guided to the area of blockage in the carotid artery and the stent is opened in position.
“Carotid artery disease and stroke affect hundreds of thousands of people each year, and carotid stenting offers patients a less-invasive treatment option when compared to open surgery,” said Sean Salmon, vice president and general manager of Medtronic Vascular’s Coronary and Peripheral businesses. “Products like the Exponent RX carotid stent and the Interceptor PLUS filter are innovatively engineered to provide effective therapy even in challenging and complex anatomies without compromising safety.”
The first procedures using the new stent and filter occurred last week at hospitals in Italy. The procedures were performed by Dr. Alberto Cremonesi and Dr. Fausto Castriota, both of the Interventional Cardio-Angiology Unit, Villa Maria Cecilia Hospital in Cotignola, Italy; and by Prof. Carlo Setacci, Professor of Vascular Surgery and Chief of Department of General and Specialistic Surgery at University Hospital Santa Maria alle Scotte in Siena.
“Successful carotid artery stenting requires careful patient selection and tailored therapy solutions,” said Professor Setacci. “The Medtronic Carotid Solution offers excellent performance in diverse clinical situations. The Exponent stent conforms and adapts very well to the carotid anatomy, and the Interceptor filter is designed to capture dangerous embolic debris as it maintains blood flow during the procedure. These characteristics give me great confidence that I can treat my patients safely and efficiently.”
Drs. Cremonesi and Castriota pointed out that modern carotid stenting procedures have two essential objectives, both directly related to patient outcomes. “Our goal with this therapy is to reduce the long-term risk of stroke while minimizing any complications from the procedure itself. The risk of embolism is always present when someone has carotid artery disease. That’s why it is so important to have products that combine safety and long-term durability to help reduce these risks.”
CE Mark approval gives Medtronic the ability to market these products commercially in European countries and other international markets. Worldwide, carotid artery stenting represent a $500 million market opportunity. Carotid endarterectomy and carotid artery stenting have been shown to benefit both symptomatic and asymptomatic patients who have severe stenosis of the carotid artery.
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 Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
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