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MEDTRONIC BEGINS CLINICAL TRIAL FOR CAROTID STENT.

Demonstrating its commitment to the continued development of clinical solutions for the entire vascular system, Medtronic, Inc. (NYSE:MDT), Minneapolis, has started enrollment for its European clinical trials to evaluate the safety and performance of its self-expanding carotid stent. Medtronic has also received approval to begin its U.S. clinical trial Patient enrollment for this trial will begin shortly.

Carotid arteries are located on either side of the neck and serve as the main conduit for blood flow to the brain. When a blood clot or a free-floating piece of plaque lodges in one of these distal tributaries, blood flow is reduced or may be eliminated. When a blocked or stenotic carotid artery is opened with a balloon or stent, atherosclerotic emboli may dislodge and migrate into the distal cranial arteries, thereby increasing the risk of a TIA (Transient Ischemic Attack) or an ischemic stroke. According to the American Stroke Association, approximately 83 percent of strokes are ischemic.

Medtronic's self-expanding carotid stent is used in conjunction with Medtronic's recently acquired GuardWire Plus(TM) Temporary Occlusion and Aspiration System from PercuSurge - these two components are designed to proactively reduce or eliminate this type of adverse event and others. The self-expanding carotid stent is designed to push the atherosclerotic material back against the artery wall, thus minimizing the chances of it becoming dislodged - the distal protection balloon is designed to capture escaped particles.

The GuardWire Plus is deployed prior to the carotid stent and serves as a guidewire for its delivery. Once in place, the balloon at the tip of the guidewire is inflated to occlude blood flow and capture any material dislodged from the wall of the vessel during placement of a stent upstream. Captured material is then withdrawn through an aspiration catheter before the balloon is deflated and blood flow to the brain is restored.

Called PASCAL (Performance And Safety of the Medtronic AVE Self-Expandable Stent in Treatment of Carotid Artery Lesions), the European clinical trial is designed to evaluate the short- and long-term safety and performance of Medtronic's self-expanding carotid stent in those patients with either symptomatic or asymptomatic artherosclerotic disease in the carotid arteries. The trial will include 100 patients whose clinical status will be monitored at both one and six months following the placement of the stent. Patient enrollment for this study has now started in select European countries.

The U.S. clinical trial will evaluate the safety and efficacy of both the carotid stent and the GuardWire Plus system in treating patients with carotid stenosis who are also high-risk candidates for the surgical procedure called carotid endarterectomy. Called the MAVErIC trial (Evaluation of the Medtronic AVE Self-Expanding Carotid Stent System With Distal Protection In the Treatment of Carotid Stenosis), the trial will begin with a Phase I feasibility study, enrolling 50 patients at 10 clinical sites across the U.S. Upon completion of Phase I, the trial will proceed to a Phase II registry, scheduled to enroll 350 patients at 40 U.S. clinical sites. Patient enrollment for this study is expected to begin shortly.

The Medtronic carotid stent is available in lengths of 20, 30 and 40 millimeters and diameters of 6, 7 and 8 millimeters. The carotid stent and the PercuSurge GuardWire Plus system are both investigational devices and are not available for commercial distribution in the United States.

Medtronic, Inc., headquartered in Minneapolis, is a leading medical technology company, providing lifelong solutions for people with chronic disease. Medtronic AVE, formerly Arterial Vascular Engineering, Inc., is headquartered in Santa Rosa, Calif.

For more information, visit http://www.medtronic.com or call 763/505-2633.
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Comment:MEDTRONIC BEGINS CLINICAL TRIAL FOR CAROTID STENT.
Publication:Biotech Equipment Update
Geographic Code:1USA
Date:Jul 1, 2001
Words:599
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