Medtronic Announces Humanitarian Regulatory Clearance for Heart-Repair Product to Serve American Children.

Business Editors/Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--Nov. 24, 2003

Medtronic, Inc. (NYSE:MDT), announced today that a Humanitarian Device Exemption has been approved by the U.S. Food and Drug Administration (FDA) making a bioprosthetic valved conduit available to correct congenital defects of the right side of the heart in children. The Contegra(R) Pulmonary Valved Conduit is composed of a bovine (cow) jugular vein containing an integral valve that can be used to reconstruct a blood pathway from the right ventricle to the patient's lungs.

The Contegra conduit can be used instead of a homograft (a human valve) currently considered the device of choice for this type of reconstruction. The supply of homografts, particularly in small sizes, is severely limited by the availability of donated human organs. Preserved with glutaraldehyde, the Contegra conduit combines many features of a homograft with the convenience of a readily available product in a range of small sizes particularly suitable for pediatric use. Contegra conduits are supplied in either an unsupported form, or in a model supported by an external cloth-covered ring on either side of the valve.

"We know we can speak for American surgeons, patients and their families in expressing gratitude for this timely regulatory action that will provide a new therapeutic option in treating these complex and surgically challenging congenital defects," said Robert Guezuraga, president, Medtronic Cardiac Surgery. "We are dedicated to serving cardiac surgeons everywhere with solutions to support their skill and expertise in saving or enhancing lives of young people with congenital cardiac disorders."

Commenting on his experience with the Contegra conduit, John W. Brown, M.D., Chief of Cardiothoracic Surgery at the Indiana University School of Medicine, and one of the leading pediatric cardiac surgeons participating in U.S. clinical trials of the device, notes that, "Prior to Contegra, the availability of pulmonary homografts in sizes less than 20 mm in diameter and the durability of pulmonary homograft conduits were 'weak links' in the surgical treatment of complex congenital heart disease. The scarcity of pulmonary homograft conduits in sizes less than 20 mm and their rather early development of dysfunction as defined by a gradient greater than 40 mmHg or greater than 2+ regurgitation have been disappointing. Contegra offers a possible solution to many of these challenges."

More than 25,000 infants are born with congenital heart defects each year in the United States. Related medical problems may be diagnosed years later, or they may be immediately life-threatening and require repair within days. The Humanitarian Device Exemption from the FDA now allows U.S. pediatric heart surgeons to use the Contegra conduit for some of these patients who previously have had few other options.

As explained by the FDA, "A Humanitarian Use Device (HUD) is a device intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year." The regulations provide for the approval of a Humanitarian Device Exemption (HDE) application that demonstrates safety and probable benefit of the device. Medtronic is currently conducting a clinical trial in the United States to further evaluate safety and demonstrate effectiveness of the Contegra conduit.

Medtronic has been distributing the Contegra conduit for use by surgeons outside the United States since 1998 and acquired the product from VenPro(R) Corporation of Irvine, Calif., in 2001. The Contegra conduit is distributed by Medtronic and is for use in patients under age 18.

Products designed for repair of heart defects in children are included in the breadth of Medtronic's technologically advanced solutions for the treatment of heart valve disease. As a leader in bioprosthetic heart valves, the company's product line features the Medtronic Freestyle(R), Mosaic(R) and Hancock(R) II valve products as well as the CG(TM) Future Band and the Duran Ancore(TM) annuloplasty systems for valve repair. Prosthetic valves include the Medtronic Hall(TM) and Hall Easy-Fit(R) mechanical valves and the Medtronic Advantage(R) bileaflet mechanical valve, which is approved for aortic use in Europe, Australia and Canada, and is under clinical evaluation in the United States.

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.

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.