St. Jude Medical Updates Status of U.S. Regulatory Filings for the RHYTHM ICD Study.

Business Editors/Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--May 14, 2004

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

Based on recent discussions with representatives of the FDA who are reviewing this pre-market approval (PMA) application, the Company is modifying its previous guidance on expected timing for approval of the products studied in the RHYTHM ICD clinical study. The Company still expects FDA approval for U.S. market release of these products to occur during the second quarter, but not by the NASPE/Heart Rhythm Society annual meeting as had been previously expected. FDA has not advised St. Jude Medical of any substantive concerns with the PMA application or identified any open issues requiring the Company's response. The Company filed the PMA on December 19, 2003, and believes this revised timeline is consistent with the statutory approval timeline for PMA submissions of 180 days.

As a result of this revised forecast of approval timing, St. Jude Medical is revising its second quarter ICD sales guidance range by $5 million and now expects ICD sales in the quarter to be in the range of $120-125 million. This revised sales guidance assumes a commercial launch in the U.S. of the products studied in the RHYTHM ICD clinical study during July 2004. Assuming approval during the second quarter of these products, the Company continues to expect full year 2004 ICD sales in the range of $550-580 million. Due to the overall strength of its businesses, St. Jude Medical reaffirms its previous EPS guidance for the second quarter in the range of $.52-.54 and for the full year 2004 in the range of $2.18 to $2.23.

The RHYTHM ICD study is a multiphase IDE trial, including an initial on/off randomized phase which studied 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 studied the QuickSite(R) 1056K over-the-wire lead system; and a third phase studying the programmable V-V timing feature of this product line.

The Aescula(TM) 1055K stylet driven lead system has been approved for U.S. market release, along with the Frontier(TM) Biventricular Pacemaker, for use in NYHA Class II and III heart failure patients who have undergone an AV nodal ablation for chronic atrial fibrillation.

St. Jude Medical announced on December 19, 2003, it had submitted to the FDA the final module of the pre-market approval (PMA) application including the clinical report from the RHYTHM ICD study. The Company's submission was made in support of the following products: the Epic(TM) HF ICD, the Atlas(R)+ HF ICD, the Aescula(TM) 1055K left heart lead and the QuickSite(R) 1056K left heart lead.

On March 9, 2004, in conjunction with the American College of Cardiology's 2004 Scientific Session in New Orleans, Louisiana, the Company announced that data from its RHYTHM ICD clinical trial showed a statistically significant improvement in peak VO2 and exercise duration for patients treated with cardiac resynchronization therapy (CRT). All prospectively defined primary safety and efficacy endpoints of the study were successfully met.

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, as previously communicated, enrollment of the minimum number of required patients has been completed and submission of this phase of the RHYTHM study is expected to occur during the second quarter of 2004. Assuming a successful outcome to this phase of the study, the Company continues to expect FDA approval and U.S. launch of this product feature by the end of 2004.

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, 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.