Medtronic Announces European Launch of New Driver Coronary Stent Using Unique Modular Technology and Cobalt-based Alloy.

Business Editors & Health/Medical Writers

SANTA ROSA, Calif.--(BUSINESS WIRE)--Jan. 27, 2003

Six-Month Preliminary Angiographic Data from U.S. Registry

Trial Suggest Promising Clinical Outcomes for Patients

Medtronic, Inc. (NYSE:MDT), today announced the European launch of its new Driver Coronary Stent System, for which the company recently received CE (Conformite europeene) Mark approval. A stent is a tiny cylindrical mesh tube that helps to prop open an artery following a balloon angioplasty to restore blood flow to diseased vessels. The first and only modular stent to be composed of a cobalt-based alloy, the Driver stent is approved for treating de novo and restenotic lesions in coronary vessels with a diameter of 3.0-4.5mm. Driver's unique design characteristics provide physicians with the flexibility they need for tracking through challenging anatomy and reaching difficult to access lesions. The new Driver stent is also designed to produce improved clinical outcomes for patients through the use of this alloy in combination with the company's modular technology.

As we age, fatty deposits and/or calcium (also referred to as plaque) build up on the inside of coronary arteries. Plaque can reduce the flow of oxygen and nutrient-rich blood to the heart, resulting in chest pains or angina. Balloon angioplasty is a procedure that uses a catheter with a small balloon on it. The balloon is inflated to push apart the plaque in the clogged arteries. This procedure improves the blood flow in the artery. In some cases, a physician will place a coronary stent in the artery to help keep it open. Peer-reviewed literature (Circulation, June 2001) suggests that thinner struts (the stent's scaffolding) may help prevent the renarrowing of vessels following an intervention. The Driver stent's advanced alloy surpasses the limitations of stainless steel by making possible very strong, ultra-thin struts that offer excellent flexibility and excellent vessel support.

The company also announced preliminary six-month angiographic results for a 101-patient subset of its U.S. Driver De Novo and Restenotic Registry Trial, which demonstrated a low 3.0 percent Target Lesion Revascularization (TLR) rate in patients with diseased coronary arteries with a diameter of 3.0-4.0mm. TLR is the need for a repeat angioplasty or coronary artery bypass following a stent implant. The data suggest that the Driver coronary stent with ultra-thin struts is effective in preventing vessels from renarrowing following an intervention to restore blood flow to diseased coronary arteries.

"Our goal is to have the Driver stent set the new standard for coronary stents as it uses our market-leading modular technology and a cobalt-based alloy that has proven highly successful in the fabrication of other Medtronic products, including pacemaker leads," said Bill Hawkins, president of Medtronic's Vascular Division. "We also believe that the Driver stent, given its promising clinical results, has great potential to serve a broad segment of the population with coronary artery disease." Hawkins explained further that the new Micro-Driver coronary stent, specifically designed for small vessels or those with a diameter of 2.25-2.75mm, also received CE Mark approval, and will launch in Europe in the first half of 2003.

"The Driver stent has a very low profile and excellent trackability, flexibility and radial strength, which makes it uniquely suited for direct stenting, which means lower risk of complications, reduced radiation exposure and lower costs of the procedure," said Dr. M.M. Khan, Consultant Craniologist, Director of the Cardiology Catheterization Laboratory at The Royal Victoria Hospital in Belfast, Northern Ireland.

The Driver Coronary Stent System builds on Medtronic's S7 platform--one of the company's most successful coronary stents--and offers the very latest in stent technology. "The Driver stent is an exciting step forward in that it combines Medtronic's modular stent design and the unique properties of the cobalt-based alloy," said Michael H. Sketch, Jr., M.D., the trial's principal investigator and the Director of the Cardiac Catheterization Laboratories at the Duke University Medical Center. Dr. Sketch added, "The Driver coronary stent is easy to deliver to the site of the lesion, conforms well to the shape of the coronary vessel, and is easy to visualize after it's deployed at the site of the lesion."

The Driver Coronary Stent System

Features for the Driver Coronary Stent System include:

-- Cobalt-based Alloy With Unique Modular Stent Design. The Driver coronary stent consists of ultra-thin struts (.0036 inches vs. .0045 with our S7), with the company's proven 10-crown design. The combination of these unique design characteristics provide physicians with the additional flexibility they need for tracking through tortuous anatomy and reaching difficult to access lesions. The small cells (which each measure less than 1 millimeter squared) allow the Driver stent to offer excellent support and coverage of the lesion, even when deployed through arterial bends.

-- Proven Delivery Technologies. The Driver stent platform incorporates two proven Medtronic delivery technologies - Discrete Technology and Secure Technology.

-- Discrete Technology provides for precise alignment of the stent on the balloon, thereby minimizing the balloon overhang extending beyond the ends of the stent and minimizing the possibility of dilating healthy tissue.

-- Secure Technology is a patented system designed to ensure that the stent remains securely on the balloon during delivery, positioning and deployment. Proximal and distal balloon pillows are created by a combination of heat and pressure to provide added security for tracking through tortuous anatomy.

-- Optimal Radiopacity. Because its cobalt-based alloy is denser than stainless steel, the Driver stent maintains optimal radiopacity, which means that it can easily be viewed under fluoroscopy. As a result, the physician can precisely place the stent and more clearly view the clinical result within the coronary anatomy.

The Driver coronary stent is available in all countries in the European Union in sizes that are 3.0, 3.5 and 4.0mm in diameter and 9, 12, 15, 18, 24 and 30mm in length. Additional sizes, including the Micro-Driver coronary stent, will be launched in Europe in the first half of 2003. A U.S. launch of the Driver Coronary Stent System is targeted for the second half of 2003.

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 www.medtronic.com. Medtronic Vascular, formerly Arterial Vascular Engineering, is headquartered in Santa Rosa, Calif. Its Internet address is www.medtronicave.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 Medtronic's Annual Report on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.