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Medtronic Announces Preliminary Data from the MAVErIC I & II Carotid Stenting Clinical Trials.

WASHINGTON -- Preliminary Data on Medtronic Exponent Carotid Stent and GuardWire(R) Occlusion System Demonstrates Early Success in Treating Carotid Artery Blockages That Can Lead to Stroke

Stephen R. Ramee, M.D., the Co-Principal Investigator of the MAVErIC(a) Clinical Trial, today presented positive preliminary 30-day data from the MAVErIC II trial and one year data from the MAVErIC I trial at the Cardiovascular Research Foundation's (CRF) Sixteenth Annual Scientific Symposium, Transcatheter Cardiovascular Therapeutics (TCT 2004). The MAVErIC I and II clinical studies, which comprise a total of 498 patients, are designed to evaluate the short- and long-term safety and efficacy of Medtronic's Exponent Carotid Stent System and the GuardWire(R) Balloon Occlusion device in reducing the incidence of stroke and death in patients with carotid artery disease.

"The preliminary data from these studies suggests that the GuardWire system, when used with the Exponent carotid stent, is successful in treating high risk patients with carotid artery disease," said Dr. Ramee. "This data indicates that balloon occlusion devices, such as the GuardWire system, used in this manner are similar to filter devices and can produce favorable results in carotid stenting procedures. Depending on the patient, it may be appropriate to fully seal a vessel via a balloon system to prevent stroke and this data suggests that the GuardWire system is a viable option for meeting this important objective."

MAVErIC II 30-Day Clinical Results

The MAVErIC II trial is a 399-patient pivotal trial designed to study the safety and efficacy of the Self-Expanding Exponent Carotid Stent with the GuardWire Balloon Occlusion and Aspiration System for the treatment of carotid stenosis. The preliminary 30-day results showed a Major Adverse Event (MAE) rate of 5.3 percent. MAE includes any stroke, myocardial infarction (MI) and/or death. The MAE rate for MAVErIC II included an MI rate of 2.0 percent, a death rate of 1.0 percent and stroke rate of 3.3 percent. The study also assessed lesion, device and procedural success, with both the Exponent stent and GuardWire system performing well in the study. The MAVErIC II Clinical Trial completed enrollment in August 2003 and is being performed at 34 centers in the United States. Patients in the MAVErIC II trial will be followed up to one year after their procedure. Medtronic anticipates that final patient follow up will occur in the fall of 2004.

The MAVErIC II trial is led by co-principal investigators: Stephen R. Ramee, M.D., F.A.C.C., Director of the Cardiac Catheterization Laboratory at the Ochsner Clinic Foundation, New Orleans, and Randall T. Higashida, M.D., Clinical Professor of Radiology and Neurological Surgery at the University of California's San Francisco Campus. The first MAVErIC II patient enrollment was initiated by James D. Joye, D.O., F.A.C.C., Director of the Cardiac Catheterization Laboratory at El Camino Hospital in Mountain View, Calif.

MAVErIC I One-Year Clinical Results

The MAVErIC I clinical trial was a 99-patient feasibility study designed to demonstrate the safety of the Self-Expanding Exponent Carotid Stent with the GuardWire Temporary Occlusion and Aspiration System for the treatment of carotid stenosis. At one year, the study found a major adverse event (MAE) rate of 5.1 percent, which was unchanged from the 30-day results. The study also demonstrated positive device, lesion and procedural success. The MAVErIC I study completed enrollment in December 2002 and was performed at 16 centers in the United States.

MAVErIC III Clinical Trial

Medtronic intends to conduct the MAVErIC III Clinical Trial in the United States, beginning in the fall of 2004, to study the safety and efficacy of the Exponent Carotid Stent System with the Interceptor(R) PLUS Filter System in reducing the incidence of stroke and death in patients with carotid artery disease.

Carotid Stenting

Carotid stenting offers the potential for a less invasive alternative to an endarterectomy, a potentially high-risk surgical procedure and the current standard of care for treating blockages in the carotid arteries.

Carotid arteries are located on either side of the neck and serve as the main conduit for blood flow to the brain. For the brain to function normally, oxygen and nutrient-rich blood must flow through these vessels. As we age, fatty deposits of cholesterol, calcium and blood platelets (typically known as plaque) build up inside arteries, including the carotids, and cause atherosclerotic disease. Over time, these deposits can reduce the flow of blood through the carotid arteries to the brain, which can result in a Transient Ischemic Attack (TIA) or an ischemic stroke. According to the American Stroke Association, every 53 seconds, someone in America has a stroke, approximately 83 percent of which are ischemic. About 600,000 Americans will have a stroke this year and 160,000 of them will die. In fact, stroke is our nation's No. 3 killer and is a leading cause of severe, long-term disability. The current gold standard for treating diseased carotid arteries is an endarterectomy, in which plaque is removed through an invasive surgical procedure requiring general anesthesia.

Embolic Protection and Carotid Stenting

When a blocked or stenotic carotid artery is opened with a balloon or stent, atherosclerotic emboli (another word for plaque) may dislodge and migrate into other arteries, blocking the flow of oxygen-rich blood to the brain and further increasing the risk of a stroke or TIA (sometimes called a "mini-stroke"). The Medtronic Exponent Carotid Stent System is designed to push the atherosclerotic material back against the carotid artery wall, and the GuardWire device is designed to block and remove dislodged particles. The GuardWire device is deployed prior to the carotid stent and also serves as a guidewire for stent delivery. Once in place, the balloon at the tip of the GuardWire device is inflated to occlude blood flow and block any material dislodged from the wall of the vessel during placement of a stent. The blocked material is then withdrawn through an aspiration catheter before the balloon is deflated and blood flow through this artery is restored.

The Exponent stent system is an investigational device and is not available for commercial distribution in the United States. The GuardWire system, the first FDA-cleared embolic protection device, has been available for use in U.S. markets since June 2001 for treating diseased saphenous vein grafts (SVGs). Medtronic pioneered embolic protection systems and is the only company which offers both balloon and filter occlusion systems (outside the United States only).

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is

(a) MAVErIC (Evaluation of the Medtronic AVE Self-Expandable Carotid Stent System with Distal Protection In the Treatment of Carotid Stenosis)

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, 2004. Actual results may differ materially from anticipated results.
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Publication:Business Wire
Date:Sep 29, 2004
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