St. Jude Medical Announces FDA Approval and First U.S. Implant of the Identity Family of Pacemakers.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 29, 2001

Device Features Numerous Advancements Including AF Suppression(TM),

Stored Electrograms, and the AutoCapture(TM) Pacing System

St. Jude Medical, Inc. (NYSE:STJ) today announced that it has received approval from the U. S. Food and Drug Administration (FDA) to market release the Identity(TM) pacemaker, the Company's newest and the world's most advanced pacemaker product line. A limited U.S. launch of these devices will begin immediately with full U.S. market release scheduled for the first quarter of 2002.

Raffaele Corbisiero, MD, Director of Electrophysiology Laboratory Services at Deborah Heart and Lung Center, Browns Mills, New Jersey, performed on November 28 the first Identity(TM) pacemaker implant in the U.S., implanting an Identity(TM) DR Model 5370 device in a 48 year old female. The patient presented with symptomatic paroxysmal atrial fibrillation (AF), sick sinus syndrome, and neurocardiogenic syncope. The patient is doing well and the device is functioning as intended.

The Identity(TM) product family, which maintains all of the therapeutic advancements of previous St. Jude Medical pacemakers including the AF Suppression(TM) Pacing Algorithm and the Beat-by-Beat(TM) AutoCapture(TM) Pacing System, significantly expands the Company's AFx(TM) feature set to include a comprehensive suite of arrhythmia diagnostics including dual-channel stored electrograms. AFx(TM) features are designed to help physicians better manage pacemaker patients suffering from atrial fibrillation (AF)--the world's most common cardiac arrhythmia.

"The Identity(TM) pacemaker represents, in many ways, the new standard in pacing technology," said Dr. Corbisiero. "It not only provides optimal bradycardia therapy, but also offers functionality that allows physicians to more effectively manage the large subset of bradycardia patients who have concomitant atrial fibrillation--a condition once thought to be manageable only with drug therapy. These device features have important clinical utility as they provide even more options to better manage patients with bradycardia and the atrial tachyarrhythmias that they have or may develop at some point in the future.

"The Identity pacemaker represents St. Jude Medical's commitment to excellence in pacing technology," added Dr. Corbisiero. "Deborah Heart and Lung Center shares this commitment and is proud to participate with St. Jude Medical in the introduction of a pacemaker that represents a quantum leap in the care of patients with sick sinus syndrome."

The Identity(TM) family of pacemakers includes three models:

-- the Identity(TM) DR Model 5370 pacemaker, the world's smallest dual-chamber
pacemaker at 18 g and 8 cc;

-- the Identity(TM) XL DR Model 5376 pacemaker, the world's longest lasting
dual-chamber pacemaker at 12.6 yrs.(1) longevity; and

-- the Identity(TM) SR Model 5172, a single-chamber configuration.

Utilizing technologies unique to St. Jude Medical, all Identity(TM) pacemakers are able to maintain very compact dimensions without compromising functionality. This small size helps benefit both patients and physicians by promoting ease of implant and patient comfort.

Identity(TM) pacemakers offer all of the advanced features of St. Jude Medical's Integrity AFx(TM) and Integrity(R) Micro pacemaker families plus several new AFx(TM) diagnostic features designed to help the physician gain insight into the effectiveness of drug/device-based AF treatment modalities and guide proper therapy. These features include:

-- Dual-channel stored electograms store over 120 seconds of

atrial and/or ventricular EGM data with markers

-- Auto Mode Switch (AMS) log contains detailed information of

the last 16 AMS episodes

-- AFx Histogram provides a graphic representation of the effect

of the AF Suppression(TM) algorithm on atrial pacing therapy.

"The release of the enhanced AFx(TM) feature set contained in the St. Jude Medical Identity(TM) pacemaker family is particularly timely given the increasing body of clinical evidence showing the significant therapeutic benefits of atrial pacing in bradycardia patients who are suffering from concomitant atrial tachyarrhythmias" said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management Division. "With the AF Suppression(TM) pacing algorithm and AFx(TM) diagnostics, the Identity(TM) product line gives physicians the tools they need to help maximize these benefits."

At the annual Scientific Sessions of the American Heart Association held earlier this month, results from several studies highlighted the therapeutic benefits of atrial pacing in bradycardia patients with concomitant atrial tachyarrhythmias. Among the clinical studies presented was the Atrial Dynamic Overdrive Pacing Trial (ADOPT) trial, which demonstrated overall reductions in atrial arrythmia burden for patients utilizing the AF Suppression(TM) pacing algorithm versus those who received conventional DDDR pacing alone.

Results of the ADOPT trial included the following:

-- the AF Suppression(TM) algorithm provided a reduction in

Atrial Fibrillation (AF) burden of 25% compared to DDDR pacing

alone with a consistent and decreasing AF burden trend

observed over time (p less than 0.05).(2);

-- the AF Suppression(TM) algorithm provided a reduction in

organized atrial tachyarrhythmia (OAT) burden (i.e. Atrial

Flutter and other atrial tachyarrhythmias) of 65.3% compared

to DDDR pacing alone (p less than 0.0005)(3);

-- the AF Suppression(TM) algorithm provided an overall reduction

in total atrial tachyarrhythmia burden (AF and OAT) of 26.5%

compared to DDDR pacing alone (p less than 0.05).(3)

Any statements made regarding the Company's anticipated 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, 2000 (see pages 4-6). Actual results may differ materially from anticipated results.

St. Jude Medical, Inc.( http://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.

(1) Autocapture(TM) Pacing system ON, 100% DDD pacing, sensor passive, stored EGMs Off, 60ppm, 0.4 ms, 2.5V atrium, 1.0V ventricle, 500 ohms.

(2) Summary of Safety and Effectiveness, P880086/S83 and P830045/S76; St. Jude Medical, CRMD.

(3) Carlson MD, et al. Dynamic atrial overdrive pacing decreases symptomatic atrial arrhythmia burden in patients with sinus node dysfunction. (abstract) Circulation 2001; 104 (supplement): II-383.