St. Jude Medical, Inc. (NYSE:STJ) announced today that it has received U.S. Food and Drug Administration (FDA) approval to add V-V (ventricle to ventricle) timing to new models of the St. Jude Medical Epic(TM) HF and Atlas(R)+ HF family of cardiac resynchronization therapy devices (CRT-Ds). The Company believes it is the first CRT-D supplier in the U.S. market to offer this expanded programmability. St. Jude Medical is completing inventory build up of these new models and expects shipments to begin December 1.

"We're excited to be the first medical device manufacturer to bring programmable V-V timing in high-voltage cardiac resynchronization devices to the U.S. market," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business. "V-V timing provides our physician customers significant flexibility to optimize therapy based on individual patient needs, which may benefit thousands of heart failure patients who also require an ICD."

V-V timing refers to the delay between contraction of the left and right ventricles, compared with simultaneous pulses to both left and right ventricles. The V-V timing feature in the Epic(TM) HF and Atlas(R)+ HF CRT-Ds allows physicians to adjust the delay between ventricular outputs, as well as choose which chamber is paced first. Patients who do not respond to simultaneous biventricular pacing systems may benefit from the sequential timing offered by V-V programmability.

Results of the V-V Timing Optimization phase of the RHYTHM (Resynchronization HemodYnamic Treatment for Heart Failure Management) ICD clinical trial served as the basis for FDA approval for including V-V timing in the CRT-Ds.

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 CRT-D.

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 CRT device. The high energy provides an extra margin of safety for patients with high or rising defibrillation thresholds.

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 5 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.

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.