St. Jude Medical Announces FDA Approval of the Riata i Lead Family, the World's Thinnest Integrated Bipolar ICD Leads.

Business Editors/Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--May 11, 2004

St. Jude Medical, Inc. (NYSE:STJ) announced today U.S. Food and Drug Administration (FDA) approval of the Riata(R) i lead family, the world's thinnest integrated bipolar implantable cardioverter defibrillator (ICD) leads.

Excellent helix visibility, handling, ease of implant and the world's thinnest ICD lead body distinguish the Riata(R) i lead family. The isodiametric body diameter of Riata(R) i leads measures 2.2 mm or 2.5 mm (depending on model), and fits an 8 French introducer. These new leads complement the full line of Riata(R) true bipolar leads already on the market.

"We expect the Riata i lead family will fulfill an important need in the integrated leads market, which currently represents 32% of total ICD lead sales," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business. "This product offering provides our physician customers with additional clinical options to optimize patient care."

The new Riata(R) i lead family allows physicians even more versatility when managing patients with high defibrillation thresholds (DFTs). The leads are available in six models: dual-coil active fixation (models 1590 and 1591) and single-coil active fixation (model 1592), which affix in the heart using an extendable-retractable helix mechanism; and dual-coil passive fixation (models 1560 and 1561) and single-coil passive fixation (model 1562), which affix in the heart using tines.

The decision to use active versus passive fixation depends in part on physician preference and the characteristics of the right ventricle. The Riata(R) i leads are multi-lumen silicone leads with St. Jude Medical's exclusive Fast-Pass(TM) coating for improved lubricity.

The main difference between a single-coil and a dual-coil lead is the path (or "vector") in which the defibrillation energy travels in and around the heart. While no specific vector is right for all patients, many physicians express preferences for a single-coil or a dual-coil ICD lead.

The many lead product variations (unipolar versus bipolar, single-coil versus dual-coil, active- versus passive-fixation mechanisms, as well as lengths and other characteristics) create a broad range of products to meet physician requirements. Many physicians develop strong and specific preferences for certain types of leads. Other physicians may prefer a certain type of lead in most cases, but like the option of alternate configurations for special cases. For that reason, offering a wide range of lead options -- such as the St. Jude Medical Riata(R) i lead family -- is important in today's market.

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (known as ventricular tachycardia or ventricular fibrillation) by delivering energy to the heart through an insulated wire or lead. Defibrillation leads also have the ability to sense cardiac activity, which is then transmitted back to the ICD for interpretation. Within the heart, the defibrillation lead contains one or two electrical coils. Electrical energy forms a circuit from the coil or coils to the ICD and back to the heart.

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.