St. Jude Medical Submits V-V Optimization Phase of the RHYTHM ICD Study to FDA for Pre-Market Approval.

ST. PAUL, Minn. -- St. Jude Medical Inc. (NYSE:STJ) announced today that it has submitted a Pre-Market Approval Supplement (PMAS) to the U.S. Food and Drug Administration (FDA) for addition of the V-V (ventricle to ventricle) timing feature to the biventricular pacing capabilities available in its cardiac resynchronization therapy device (CRT-D) product line, including the Epic(TM) HF CRT-D and Atlas(R)+ HF CRT-D, which received FDA approval on June 30. The results of the V-V timing optimization phase of the RHYTHM (Resynchronization HemodYnamic Treatment for Heart Failure Management) ICD clinical trial serve as the basis for the submission.

The V-V Optimization phase of the trial studied the effects of V-V timing, the delay between contraction of the left and right ventricles, compared with simultaneous pulses to both left and right ventricles. This V-V timing feature, when added to the St. Jude Medical Epic(TM) HF and Atlas(R)+ HF ICDs, will allow physicians to adjust the delay between ventricular outputs, as well as choose which chamber is paced first. FDA approval and U.S. launch of this product feature is expected around year-end.

"Programmable V-V timing is an important feature of our high-voltage cardiac resynchronization device offerings that has proved valuable to our international physician customer base," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business. "We look forward to bringing this therapy optimization programming parameter to our U.S. customer base."

The objective of this phase of the RHYTHM ICD study was to demonstrate that optimizing the interventricular timing of biventricular pacing therapy results in exercise capacity (peak VO2) or in the left ventricular end systolic diameter (obtained by echocardiography) that is not inferior to simultaneous biventricular pacing in an ICD-indicated patient population with advanced heart failure (NYHA Classification III or IV and wide QRS).

Resynchronization effectiveness was evaluated in terms of exercise capacity, as measured by peak VO2 during cardiopulmonary exercise testing, and evidence of reverse remodeling, as measured by a change in left ventricular end systolic diameter (LVESD) during echocardiography.

Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body. About five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. The economic burden of heart failure is estimated at $40 billion per year.

The St. Jude Medical Epic(TM) HF CRT-D 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 CRT-D shares identical functionality to the Epic(TM) HF CRT-D, with the addition of the highest energy output (36 joules delivered/42 joules stored) of any cardiac resynchronization therapy device. The high energy provides an extra margin of safety for patients with high or rising defibrillation thresholds.

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, 2003 (see pages 11-16). 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.