St. Jude Medical Provides Update on Status of U.S. Regulatory Filings for the RHYTHM ICD Study.

Business Editors/Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 26, 2003

St. Jude Medical, Inc. (NYSE:STJ) provided today an update on the status of its planned regulatory filings to the U.S. Food and Drug Administration (FDA) for the RHYTHM (Resynchronization Hemodynamic Treatment for Heart Failure Management) ICD study.

The Company is finalizing a submission on the following products:

-- Epic(TM) HF ICD

-- Atlas(R)+ HF ICD

-- Aescula(TM) 1055K left heart lead

-- Quicksite(TM) 1056K left heart lead

In order to incorporate the clinical data for the Quicksite(TM) 1056K lead into this submission, St. Jude Medical plans to submit its filing to the FDA the week of December 15, 2003. The Company continues to anticipate that highlights of the RHYTHM data will be presented in conjunction with the annual meeting of the American College of Cardiology (ACC) in March 2004. St. Jude Medical anticipates FDA approval of the PMA for these products by the NASPE/Heart Rhythm Society meeting in May 2004.

The RHYTHM ICD study is a multiphase pre-market approval (PMA) trial, including an initial on/off randomized phase studying the St. Jude Medical Epic(TM) HF ICD with the Aescula(TM) 1055K stylet driven lead system in heart failure patients; a second phase which studies the Quicksite(TM) 1056K over-the-wire lead system; and a third phase which studies the programmable V-V timing feature of this product line.

During the third quarter the Company elected to submit this study as a modular PMA. The first module covering the manufacturing aspects of these product lines was submitted to the FDA in August.

With respect to the Quicksite(TM) phase of the RHYTHM ICD study, the Company previously communicated that it had completed the minimum enrollment requirements for this phase during the third quarter of 2003. Follow-up for patients enrolled in this phase will be completed during the week of December 1, 2003.

With respect to the third phase of the RHYTHM ICD study focused on the programmable V-V timing feature of the Epic(TM) HF system, enrollment of the minimum number of required patients has now been completed and submission of this phase of the RHYTHM study is expected to occur by the end of the second quarter of 2004. Assuming a successful outcome to this phase of the study, FDA approval and U.S. launch of this product feature is expected by the end of 2004.

The St. Jude Medical Epic(TM) HF ICD is the world's smallest high-voltage cardiac resynchronization device, designed to make implantation easier while improving patient comfort and cosmetic appearance. The device delivers 30 joules of energy in a physiologic-shaped 36-cc ICD.

The St. Jude Medical Atlas(R)+ HF ICD has identical functionality to the Epic(TM) HF ICD. It provides the highest energy output (36 joules delivered/42 joules stored) of any cardiac resynchronization therapy ICD.

The Aescula(TM) 1055K left-heart lead is a stylet-driven silicone insulated lead with a titanium nitride (TiN) coated platinum-iridium electrode.

The Quicksite(TM) 1056K lead is St. Jude Medical's next generation pacing lead adding over-the-wire capabilities for placement in the coronary sinus to enable left ventricular pacing in cardiac resynchronization applications.

Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, timing of 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.