Medtronic Receives FDA Approval For the Sprinter Semi-Compliant Over-The-Wire Balloon Dilatation Catheter.

SANTA ROSA, Calif. -- Sprinter Balloon Designed to Treat the Most Challenging Coronary Lesions

Medtronic (NYSE:MDT) announced today that it has received Food and Drug Administration (FDA) approval for the marketing of the Sprinter(R) Semi-Compliant Over-the-Wire Balloon Dilatation Catheter in the United States. The Sprinter balloon is immediately available in lengths of 6, 12, 15, 20, 25 and 30 mm and diameters ranging from 1.5 to 4.0 mm.

During angioplasty procedures, a balloon catheter is threaded through the femoral artery to the lesion and inflated, compressing the plaque associated with coronary artery disease against the vessel wall and restoring blood flow. A semi-compliant balloon, such as the Sprinter balloon approved by the FDA, is used to open the blood pathway in coronary arteries before a stent is implanted. As one of the first devices typically used in a coronary stenting procedure, a semi-compliant balloon must navigate smoothly through difficult and heavily compacted lesions in order to pre-dilate a lesion for stenting. More than 1 million balloon angioplasty procedures are performed each year in the United States, with more than 2.3 million balloon angioplasties performed worldwide.

"The Sprinter balloon, available as the Sprinter Rapid Exchange (RX) balloon outside the United States, has been the most successful balloon we have ever introduced, and it has received enormous praise and acceptance throughout Europe and Japan," said Scott Ward, president of Medtronic Vascular. "In many hospitals outside the United States, the Sprinter RX balloon has become the balloon of choice, establishing a new benchmark in balloon technology. I anticipate similar success in the U.S. as physicians experience for themselves the excellent deliverability and crossing characteristics of the Sprinter Over-the-Wire (OTW) version of this balloon system now approved for use in the United States."

The Sprinter balloon incorporates advanced technology, which enhances it deliverability and crossing ability in the toughest coronary lesions. Among its capabilities:

--FasTrac(TM) Tapered Tip - Low-profile FasTrac tapered tip is engineered to reach and treat the most challenging lesions. The Sprinter offers the lowest lesion-entry profile (0.016 in.) in its class(a).

--MiniWrap Folding Process - This automated folding process provides for an extremely tight wrap of the balloon on the catheter and incorporates market-leading rewrap properties for multiple inflations.

--Selective Dura-Trac Coating - The Sprinter Balloon is coated after it is folded, providing the performance of a fully coated balloon while tracking through tortuous vessels. The material inside the folds is uncoated, which provides traction upon expansion in the lesion.

In addition to these technology benefits, the Sprinter balloon will be offered in the U.S. in a 1.5 mm diameter, uniquely designed from the 2.0 - 4.0 mm diameters, making it particularly suited for ultra-tight lesions.

The Sprinter balloon joins the NC Stormer(R) family of balloons, which have been specifically designed to address the needs of cardiologists in the era of drug-eluting stents. The lengths of the NC Stormer balloon match the lengths of deployed drug-eluting stents in an effort to protect healthy tissue.

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

(a) Based on test data on file at Medtronic Vascular. Comparisons made to Sprinter balloon catheter are versus leading competitors in the United States marketplace.

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 25, 2003. Actual results may differ materially from anticipated results.