FDA Approves St. Jude Medical's High-Voltage Cardiac Resynchronization Therapy Device System.

ST. PAUL, Minn. -- St. Jude Medical, Inc. (NYSE:STJ) announced today approval by the U.S. Food and Drug Administration (FDA) of its high-voltage cardiac resynchronization therapy (CRT-D) device system, including the Epic(TM) HF and Atlas(R)+ HF ICDs and the QuickSite(R) left-heart pacing lead. The approval was based on the results of the RHYTHM (Resynchronization HemodYnamic Treatment for Heart Failure Management) ICD study, which demonstrated a significant improvement in Peak VO2, exercise duration, NYHA Class and Quality of Life in patients treated with CRT. The system is indicated to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left-ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration.

Full U.S. market release of St. Jude Medical's high-voltage cardiac resynchronization device system will begin immediately. The Company believes it has adequate inventories on hand in support of the U.S. market release of these products.

"St. Jude Medical's state-of-the-art CRT-D device system allows fast, easy implantation and extremely flexible device feature options for patients suffering the debilitating effects of ventricular dyssynchrony and heart failure," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business. "Our seamlessly integrated system of delivery tools, leads and CRT devices offers the latest technology advances to optimize cardiac resynchronization therapy."

The St. Jude Medical CRT system provides physicians a choice of two sophisticated devices that combine pacemaker therapy, defibrillation therapy and biventricular stimulation to treat the complexities of heart failure:

--The Epic(TM) HF CRT-D, the world's smallest resynchronization device with 30 joules of delivered energy, is designed for improved patient comfort. This may be especially important for patients when small size is critical.

--The Atlas(R)+ HF CRT-D, with 36 joules of delivered energy, is the world's most powerful resynchronization device and provides increased safety margins for patients with -- or likely to develop -- high defibrillation thresholds.

These devices monitor every heartbeat and provide biventricular pacing to reduce the symptoms of moderate to severe heart failure. To help ensure effective resynchronization therapy, the devices can be programmed to use Negative AV/PV Hysteresis to automatically shorten the AV/PV delay when needed and promote biventricular pacing. The devices feature the most flexible programming options available for both defibrillation threshold (DFT) and sensing management. The CRT-Ds also deliver anti-tachycardia pacing, cardioversion and defibrillation to immediately treat life-threatening ventricular tachyarrhythmias, which can lead to sudden cardiac death.

The therapeutic flexibility of these sophisticated devices is complemented by the ease of use of the QuickSite(R) Model 1056K left-heart lead. This lead was specifically designed for improved pushability, torqueability and tracking with its composite polyurethane/silicone lead body construction, and for a reduced risk of dislodgement due to its unique S-shape fixation mechanism. The lead can be positioned in the cardiac venous system using either an over-the-wire or stylet-driven approach during the same procedure.

The flexibility and ease of use of the St. Jude Medical CRT system are further enhanced by unique lead delivery tools that the Company has recently introduced, including:

--The Apeel(TM) CS catheter delivery system, designed in five curve sizes to provide coronary sinus access even in the most difficult cases.

--The Reflexion Cannulator(TM) catheter with lumen, engineered to enhance steerability and visibility.

Follow-ups for patients implanted with the Atlas(R)+ HF or Epic(TM) HF devices are simplified with the Housecall Plus(TM) system, the only remote monitoring system that offers real-time data transmissions and live interaction with a medical professional by telephone to evaluate the patient's heart and device. Physicians receive the same real-time data and complete diagnostics from a Housecall Plus(TM) system monitoring session as they would from an in-office visit.

The RHYTHM ICD study was a prospective, double blinded, randomized control, multicenter clinical trial enrolling 205 patients. An additional 162 patients were enrolled in the QuickSite(R) lead phase of the study. Patients enrolled in the RHYTHM ICD study had an approved indication for an implantable cardioverter-defibrillator, an ejection fraction of less than or equal to 35% and a prolonged QRS duration, as well as symptomatic, advanced heart failure (NYHA Class III/IV) despite receiving optimal pharmacological therapy for a minimum of 90 days. Patients were randomized (2:1) to receive CRT therapy (CRT ON) or act as control (CRT OFF).

The study demonstrated the following:

--The primary cardiac resynchronization therapy (CRT) efficacy endpoint was met. The CRT ON (treatment) group showed a statistically significant improvement over the CRT OFF (control) group from baseline to 6 months in peak VO2 during cardiopulmonary exercise testing (1.9 ml/kg/min; p = 0.001), as well as a greater improvement in exercise time (p = 0.002).

--Two out of the three secondary CRT efficacy endpoints were met with the third showing a strong trend towards significance. The CRT ON group showed a statistically significant improvement over the CRT OFF group in NYHA Class (p = 0.048) and in Quality of Life as measured by the Minnesota Living with Heart Failure Questionnaire (p = 0.009). The CRT ON group also showed a strong trend toward improvement over the CRT OFF group in the 6-minute walk test, but that did not quite reach statistical significance (p = 0.07).

--QuickSite(R) lead implant success rate was 94.4% with a mean chronic pacing capture threshold of 1.6 +/- 1.4 V.

--Survival from QuickSite(R) lead-related complications was 96.1% with only one reported lead dislodgement (0.65%).

--All safety endpoints in the trial were met and the results well exceeded the protocol specified performance criteria.

"The RHYTHM ICD clinical study clearly demonstrates the important therapeutic benefits of CRT-D therapy to symptomatic heart failure patients with low ejection fractions and prolonged QRS complexes," said Eric S. Fain, MD, Senior Vice President of Technology Development, Clinical and Regulatory Affairs for St. Jude Medical's Cardiac Rhythm Management business. "The consistently positive results across all endpoints in the RHYTHM ICD study, as well as the high quality of the clinical data provided in support of this submission, made the FDA review process straightforward and expeditious, and are a testament to the excellent clinical research by each of the 59 centers that participated in the RHYTHM ICD study."

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.