St. Jude Medical Announces FDA Approval, CE Marking and First Implants of Active-Fixation Lead with Improved Visibility and Performance.

Business Editors/Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--July 8, 2003

St. Jude Medical, Inc. (NYSE:STJ) announced today U.S. Food and Drug Administration (FDA) approval, European CE Marking, and the first implants of the Tendril(R) SDX Model 1688 active-fixation pacing lead. The Model 1688 lead, built upon St. Jude Medical's proven Tendril(R) SDX cardiac lead technology, features a redesigned titanium distal tip with platinum markers and a radiopaque suture sleeve to facilitate precise location under fluoroscopy.

"The platinum markers significantly enhance fluoroscopic visibility, making it easier to verify helix extension and to achieve optimal placement," said Dr. Charles Love, who performed the first U.S. implant of the Tendril(R) SDX Model 1688 lead at the Ohio State University Medical Center in Columbus, Ohio. "The lead combines the best characteristics of the 1388 and 1488 to make a superb pacing lead. In addition, the ability to map intracardiac signals is excellent."

Dr. Johan Brandt performed the first European implant at University Hospital in Lund, Sweden, one of the most experienced implanting centers in Europe. "The implant procedure went very smoothly and I attribute that, in large part, to the Tendril SDX lead's clear visibility under fluoroscopy," said Dr. Brandt. "The slim lead body and the surface coating results in excellent handling characteristics, which facilitated dual-lead introduction through the cephalic vein."

Both patients are doing well and the lead systems are performing as expected.

The Tendril(R) SDX Model 1688 lead introduces refinements on the Company's most popular pacing lead and responds to growing enthusiasm within the medical community for active-fixation devices.

"As the diagnostic and therapeutic functionality of cardiac rhythm management devices continues to expand, especially in the area of co-morbidity management, implanting physicians are looking for increased functionality and ease of use from their lead products," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business. "St. Jude Medical is committed to continually advancing the state-of-the-art of lead technology across all of our lead product families. The feature enhancements embodied in the Tendril(R) SDX Model 1688 are clear evidence of that commitment within the active-fixation pacing lead product segment."

Based on physician feedback, St. Jude Medical has incorporated several significant improvements in the new lead. The Tendril(R) SDX Model 1688 lead's 10 mm tip-to-ring spacing is designed to reduce far field sensing compared to leads with wider spacing. The new suture sleeve, impregnated with barium sulfate to facilitate radiopacity, features three symmetrical grooves to give implanting physicians more choices when anchoring the lead. The bipolar Tendril(R) pacing lead has a small body, allowing it to be threaded through a thin 7F (French) sheath. Availability in a wider array of lengths (34-85 cm) gives physicians many treatment options.

The steroid-eluting lead reduces the energy requirement needed for pacing. The titanium nitride (TiN) fractal coating on both the tip and ring keep polarization low and St. Jude Medical's exclusive AutoCapture(TM) Pacing System compatibility high. (AutoCapture(TM) is the world's first and only threshold-tracking algorithm to combine capture confirmation with a unique backup safety pulse to ensure capture Beat-by-Beat(TM).)

Pacemaker leads are typically inserted through a vein and connect the heart to a pacemaker. The Tendril(R) SDX Model 1688 lead's active-fixation mechanism, containing a tiny helix that literally screws into the heart, allows a physician to securely position the lead in areas where a passive-fixation lead would not be stable.

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.