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St. Jude Medical Announces First U.S. Implant of the Integrity(TM) AFx AutoCapture(TM) Pacing System with Dynamic Atrial Overdrive(TM) (DAO).

ST. PAUL, Minn., May 18 /PRNewswire/ --

St. Jude Medical, Inc. (NYSE: STJ) today announced the first U.S. implant of the Integrity(TM) AFx (model 5346)* AutoCapture(TM) Pacing System based on an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). The Integrity(TM) AFx incorporates St. Jude Medical's proprietary Dynamic Atrial Overdrive(TM) (DAO) algorithm designed to suppress atrial fibrillation (AF). The implant was performed on May 8 by J.E. Val-Mejias, M.D., FACC, Director of the Cardiac Electrophysiology Laboratory at Via Christi Regional Medical Center, St. Francis Campus, in Wichita, Kan., as a part of St. Jude Medical's ADOPT-A clinical trial. Dr. Val-Mejias implanted the dual-chamber rate-responsive Integrity AFx DR device in a 74-year-old male patient.

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"This was an exceptional case of an elderly male with severe COPD (chronic obstructive pulmonary disease) and sick sinus syndrome with syncope. In addition, this patient had frequent premature atrial contractions and bouts of atrial fibrillation where anti-arrhythmic drugs like amiodarone and sotolol were not a viable option," said Dr. Val- Mejias. "In this case, the Integrity AFx DDDR pacer with DAO stimulation was the most effective therapy to manage this patient's condition. By continuously stimulating the atrium at patient-tailored rates, this algorithm maintains AF suppression capabilities without compromising the other functions of the device. I'm very optimistic that the ADOPT-A study will prove the efficacy of this state-of-the-art algorithm."

The ADOPT-A (ADOPT= Atrial Dynamic Overdrive Pacing Trial) study is designed to investigate whether the Dynamic Atrial Overdrive(TM) (DAO) algorithm can suppress symptomatic episodes of paroxysmal atrial fibrillation (AF). The clinical study includes patients with bradycardia and AF. ADOPT-A is being conducted in the United States, Canada and the United Kingdom and is nearing completion, with 250 patients currently enrolled in the study.

In the United States, AF presents an immense health care and financial burden. The most common significant cardiac arrhythmia, AF affects over 2 million people in the US, with annual medical expenditures exceeding $1 billion. Until recently, approaches to AF treatment centered on pharmacological therapy. However, patient side effects associated with drug therapy have led clinicians and the medical technology industry to pursue device-based AF management as an option.

The first algorithm designed to suppress paroxysmal atrial fibrillation (AF), the St. Jude Medical Dynamic Atrial Overdrive (DAO) algorithm stimulates the atrium slightly above the patient's intrinsic rhythm in order to "control" the atrium, thereby preventing the onset of AF and its associated symptoms. The algorithm is designed to continuously monitor intrinsic atrial activity and provide a stimulation rate slightly above the patient's intrinsic rhythm. The DAO algorithm is designed to stimulate the patient's atrium a high percentage of the time at patient-tailored rates-whether the patient is active or at rest.

With the introduction of the Integrity(TM) AFx DR AutoCapture(TM) Pacing System into the ADOPT-A clinical trial, investigators now have the option of using both the AutoCapture(TM) Pacing System and the Dynamic Atrial Overdrive algorithm together in one device. Investigators also have the flexibility of providing atrial overdrive stimulation therapy, without sacrificing the safety and longevity benefits of the AutoCapture Pacing System.

In addition to the DAO algorithm, Integrity(TM) AFx incorporates the AutoCapture(TM) Pacing System technology and offers an extensive array of patient management options. Building on the clinically proven Affinity(R) pacemaker platform, the Integrity AFx pacemaker offers several advanced and customer-driven features, including:

-- New AutoCapture Pacing System flexibility which offers a back-up safety

pulse that is programmable to a bipolar or unipolar configuration.

-- Advanced Hysteresis that provides clinicians the option to select how

frequently the device will search for intrinsic rhythm and the number

of cycles that each search will include.

-- Programmable Auto Mode Switch (AMS) Base Rate to compensate for the

loss of atrial contribution that may occur during mode switching.

-- Automatic P&R wave measurements that automatically measure the

amplitude of P&R waves and recommend an appropriate sensitivity setting

(for fast and efficient follow-up).

-- Noninvasive Programmed Stimulation (NIPS) that allows clinicians to

perform certain types of electrophysiology (EP) testing without the

need for external stimulators or catheterization.

In addition to those specific features, the Integrity AFx AutoCapture(TM) Pacing System offers the clinically proven Omnisense(TM) accelerometer sensor, a VDD/R mode option and comprehensive diagnostics through St. Jude Medical's universal programmer platform, the Model 3510 Programmer.

Any statements made regarding the Company's anticipated revenues, expenses and earnings are forward-looking statements which are subject to risks and uncertainties, such as those described in the Company's Annual Report on Form 10-K for the year ended December 31, 1999 (see pages 26-28). Actual results may differ materially from anticipated results.

St. Jude Medical, Inc. ( ) is dedicated to the design, manufacture and distribution of innovation medical devices of the highest quality, offering physicians, patients and payers unmatched performance and demonstrated economic value.

*Investigational Device. Limited by Federal (or United States) law to

Investigational use.
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Publication:PR Newswire
Geographic Code:1USA
Date:May 18, 2000
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