St. Jude Medical Announces FDA Approval of Isoflex S Lead and First Implant of Isoflex P Lead, New Bradycardia Pacing Leads.

Business Editors/Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--April 14, 2003

St. Jude Medical, Inc. (NYSE:STJ) today announced two milestones for its new IsoFlex(R) family of cardiac pacing leads. The U.S. Food and Drug Administration (FDA) approved the IsoFlex(R) S (silicone) pacing lead and the first implant of the IsoFlex(R) P (polyurethane) pacing lead took place under an FDA investigational device exemption (IDE) study.

Paul K. Safer, M.D., FACS, performed the first implant of the St. Jude Medical IsoFlex(R) P lead at Middlesex Hospital in Middletown, Connecticut. The lead was implanted with a St. Jude Medical Affinity(R) SR Model 5130 pacemaker in an 81-year-old man. The implant proceeded as expected and the patient is doing fine. "The Isoflex(R) P lead handled very well and helped make the entire procedure run smoothly," said Dr. Safer. "The thin profile and smooth sliding characteristics made cephalic vein implantation very easy." Dr. Safer previously performed the first U.S. implant of the IsoFlex(R) S lead.

"The downsized IsoFlex(R) family of silicone and polyurethane leads gives implanting physicians greater flexibility in choosing a lead that's just right for each patient," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business.

The St. Jude Medical IsoFlex(R) P lead's reduced diameter allows it to be threaded through a 7 French (2.32 mm) introducer sheath. Both the IsoFlex(R) S and IsoFlex(R) P pacing leads are manufactured in straight and J shapes, allowing for ventricular and atrial use, respectively. The leads are also available in bipolar or unipolar configurations.

St. Jude Medical plans an immediate U.S. market release of the IsoFlex(R) S lead. The device received European CE Marking in September 2002 and has been available in all countries of the European Union since early 2003. The IsoFlex(R) P lead continues to be evaluated as part of a St. Jude Medical clinical study. FDA approval is expected later this year. These leads expand the Company's portfolio of state-of-the-art bradycardia pacing leads.

IsoFlex(R) cardiac pacing leads are insulated wires connecting a pacemaker to a patient's heart. Electrical impulses transmitted from the pacemaker through the lead stabilize the heart rhythm. This therapy is often recommended for patients with bradycardia, a slow and debilitating heart rhythm.

Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2002 (see pages 6-8). Actual results may differ materially from anticipated results.

St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.