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St. Jude Medical Receives FDA Approval of Integrity AFx(TM) DR Model 5346, The First U.S. Approved Pacemaker Demonstrated to Suppress Atrial Fibrillation (AF) in Patients With Pacing Indications.

ST. PAUL, Minn., July 11 /PRNewswire/ --

St. Jude Medical, Inc. (NYSE: STJ) announced today it has received pre-market approval (PMA) from the United States Food and Drug Administration (FDA) to market release the Integrity AFx(TM) DR Model 5346 pacemaker featuring the Dynamic Atrial Overdrive (DAO) algorithm, a clinically-proven* new feature designed to suppress Atrial Fibrillation (AF)-- the most common cardiac arrhythmia. The Integrity AFx(TM) DR Model 5346 pacemaker marks the first time a device offering stimulation therapy demonstrated to suppress AF has been commercially available in the United States.

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Atrial fibrillation, the most common chronic arrhythmia, affects 5 million people worldwide. In the United States, AF presents an immense health care and financial burden, affecting over 2 million people with annual medical expenditures exceeding billions of dollars. The prevalence of AF increases strikingly with advancing age -- 4% of men and women in the U.S. older than 60 and 10% of those older than 80 have AF. Characterized by rapid, uncoordinated and uncontrolled contractions of the atria, the upper chambers of the heart, AF keeps the heart from pumping blood efficiently. AF is a common risk factor for -- and cause of -- stroke. AF also markedly diminishes quality of life, and exacerbates heart failure (HF). In fact, an estimated 25% of HF patients also have AF. Until recently, approaches to AF treatment centered primarily on pharmacological therapy.

"St. Jude Medical's AFx Suppression serves as a novel, new device-based approach to suppressing AF through 'smart' overdrive stimulation," noted Dr. John Messenger, Director, Heart Institute, Memorial Hospital Long Beach, Long Beach, Calif. "Most importantly, AFx Suppression has demonstrated clinical efficacy in treating AF, as evidenced by its sound clinical performance. I find this promising, especially when you take into account that many approaches to managing AF have notable flaws. Drug therapy, for instance, requires strict patient compliance regimens and side effects are frequently a detriment for their use. Furthermore, when this (AF Suppression) therapy is effective, the benefits are almost like magic."

FDA approval of the Integrity AFx(TM) DR Model 5346 pacemaker follows the completion of the Atrial Dynamic Overdrive Pacing Trial -- A (ADOPT-A), which demonstrated that patients with pacing indications receiving AFx Suppression therapy experienced a reduction in symptomatic AF episodes as well as significant improvements in Quality of Life (QoL) without any device-related complications and no reported unanticipated adverse events.

St. Jude Medical's AFx Suppression technology is designed to continuously monitor intrinsic atrial activity and stimulate the atrium slightly above the patient's intrinsic rhythm in an attempt to "control" the atrium, thereby suppressing the onset of paroxysmal (brief episodes) and persistent (longer episodes) AF and their associated symptoms. While it has been widely accepted that standard DDDR pacing can reduce the occurrence of AF as compared to VVIR pacing, the completed ADOPT-A study demonstrates that AFx Suppression provides an increased reduction in symptomatic AF as compared to standard DDDR pacing. Furthermore, unlike standard DDDR pacing at a fixed higher base rate which can cause patient discomfort, AFx Suppression provides atrial stimulation at well tolerated, patient-tailored rates, whether the patient is active or at rest.

"This FDA approval of the Integrity AFx DR model 5346 and the reporting of the ADOPT-A results at NASPE in May are important milestones in St. Jude Medical's commitment to be the industry leader in device-based suppression, interdiction, and cure of atrial fibrillation, a significant global healthcare challenge," noted Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management Division. "We intend to expand AFx Suppression capabilities to future standard low- and high-voltage device platforms, including cardiac resynchronization products, while we continue to develop catheter-based curative approaches to AF."

ADOPT-A was a randomized, controlled, single-blinded study conducted at 41 leading medical centers in the U.S., Canada, and in the United Kingdom. Patients enrolled in the study were randomized into two groups: one with the AFx Suppression algorithm "ON" and DDDR pacing at 60 ppm; the other the AFx Suppression algorithm "OFF" and DDDR pacing at 60 ppm. The trial, which spanned two-and-a-half years, featured approximately 200 patients in each group.

The ADOPT-A trial's most notable results were as follows:

-- In patients in the AFx Suppression algorithm "ON" group, symptomatic AF

burden was 25.03% less than the AFx Suppression algorithm "OFF" group,

and there was a consistent and decreasing AF burden trend observed over

time (p<0.05).

-- Over 90% of the symptomatic atrial arrhythmias observed during the

6-month follow-up period were AF (vs. other organized atrial

tachycardias) demonstrating the algorithm's effectiveness in this most

prevalent and difficult to treat atrial arrhythmia.

-- The percentage of beats that were atrial paced was significantly

greater in the AFx Suppression algorithm "ON" group (92.9%) than the

AFx Suppression algorithm "OFF" group (67.9%), demonstrating that the

algorithm performed as intended in stimulating the patient's atrium a

very high percentage of the time.

-- Quality of Life (QoL) scores for standardized physical and mental

components improved in the AFx Suppression algorithm "ON" group, while

only improving for the standardized mental component in the AFx

Suppression algorithm "OFF" group.

-- Patient demographic, anti-arrhythmia drug (AAD) use and pre-implant

number of symptomatic AF episodes data shows a well-balanced

distribution between the control group (AFx Suppression algorithm

"OFF") and the treatment group (AFx Suppression algorithm "ON").

Added Coyle, "We are enthusiastic that this effective, well tolerated, and easy-to-use AFx Suppression feature is now available to our U.S. physician customers for use in their pacemaker indicated patients who have or may go on to develop atrial fibrillation."

In Europe, the Dynamic Atrial Overdrive algorithm's AFx Suppression therapy has been commercially-available for over two years. The algorithm is featured in several St. Jude Medical CE-Marked products, the Integrity AFx(TM) Model 5346 pacemaker as well as the Frontier(TM) 3 x 2 biventricular resynchronization device.

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.( ) 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.


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Publication:PR Newswire
Geographic Code:1USA
Date:Jul 11, 2001
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