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St. Jude Medical Announces First Implant of the Identity Pacemaker, the Company's Newest and Most Advanced Bradycardia Product.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 1, 2001

New Device Family Offers an Array of Therapeutic

and Diagnostic Tools Designed to Improve Management of

Atrial Fibrillation (AF) in Pacemaker Patients

St. Jude Medical Inc. (NYSE:STJ) announced today the first implant of its Identity(TM) XL DR pacemaker. The Identity pacemaker family represents a convergence of St. Jude Medical's most innovative bradycardia technologies all in one product platform. The most notable of the Identity pacemaker family's advancements is the AFx(TM) feature set, a suite of clinically proven diagnostic and therapeutic capabilities designed to better manage pacemaker patients suffering from atrial fibrillation (AF)-- the world's most common cardiac arrhythmia.

"The Identity pacemaker makes patient management much easier, providing several diagnostic and therapeutic features that help physicians better assess the nature and origin of their patient's cardiac arrhythmia and more effectively treat concomitant symptoms," said Dr. Johannes Sperzel, Kerckhoff Heart Center, Bad Nauheim, Germany, who performed the world's first Identity pacemaker implant. Dr. Sperzel implanted the Identity(TM) XL DR pacemaker in a 77-year-old male with sick sinus syndrome and paroxysmal atrial fibrillation (AF). The patient is doing well and the device is functioning as intended.

The Identity pacemaker family includes three models:
-- the Identity(TM) DR--the world's smallest dual-chamber pacemaker (8cc, 18

-- the Identity(TM) XL DR--a dual-chamber pacemaker with battery components and
circuitry designed for long life; and

-- the Identity(TM) SR--a single chamber configuration (7.9 cc, 17 g).

Utilizing technologies unique to St. Jude Medical, all Identity 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 pacemakers offer all of the advanced features of the St. Jude Medical's Integrity AFx(TM) and Integrity(R) micro pacemaker families plus several new diagnostic features including stored electrograms, Automatic Mode Switch (AMS) log, and AFx histogram. These features can help the physician gain insight into the effectiveness of drug/device-based AF treatment modalities and guide proper therapy.

"The principle design objective for the Identity product line was to create the pacemaker of choice for physicians struggling with the challenge of drug resistant atrial fibrillation (AF) in their bradycardia patients," commented Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management Division. "The diagnostic and therapeutic capabilities of this product family are intended to not only enhance the tool kit available to physicians for managing these patients, but do so with features that are easy to use, quick to program, and well tolerated by patients."

The Identity pacemaker family's AFx(TM) feature set includes:

Therapeutic Features:

Clinically-Proven AF Suppression(TM) Algorithm(1) - monitors intrinsic atrial activity and electrically stimulates 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 its associated symptoms. As the recently completed ADOPT-A trial showed, AF Suppression provided a 25% decrease in AF burden compared to standard DDDR pacing alone and there was a consistent and decreasing AF burden trend observed over time (p less than 0.05). The algorithm also provided a 60% reduction in symptomatic AF episodes when comparing AF episodes 6 months prior to implant vs. 6 months post implant (p less than 0.0001)(a).

Enhanced Automatic Mode Switch(2) (AMS) - helps mitigate symptoms associated with prolonged ventricular pacing in response to atrial tachyarrhythmias by switching from a tracking (where the ventricular paced rate follows the sensed atrial rate) to a non-tracking mode (where the ventricular rate paces independent of the atrial rate); enhancements to the algorithm allow for programmable cross-sensor mode switching, which allows the device to go from a rate-responsive mode to a non-rate-responsive mode (or vice-versa) during the mode switch.

Programmable AMS Base Rate(1) - provides for independent regulation of the ventricular pacing rate during atrial tachyarrhythmias; this feature provides for a separately programmable elevated ventricular rate during mode switch episodes. AMS Base Rate is designed to minimize abrupt ventricular rate decelerations during mode switch episodes and improve cardiac output which may decrease due to the loss of efficient atrial function.

Diagnostic Features:

Dual Channel Stored Electrograms(2) - stores over one hundred and twenty seconds of atrial and/or ventricular EGM data (with markers); features numerous arrhythmia storage triggers including Automatic Mode Switch Entry, Automatic Mode Switch Exit, High Atrial Rate, and High Ventricular Rate; allows for storage of up to twelve separate events.

Auto Mode Switch (AMS) Log(2) - contains a record of the last 16 AMS episodes in the order of the occurrence, with each episode's date, time, duration, and maximum rate achieved.

Auto Mode Switch (AMS) Histogram - displays a graphic representation of mode switch activity; includes the number of mode switch episodes for the average atrial rate range; and the number of mode switch episodes for each episode duration.

AFx Histogram(1),(2) - provides a graphic representation of the distribution of all atrial paced and sensed events that have occurred while the AF Suppression algorithm was activated.

Clinical Significance of Atrial Fibrillation (AF)

AF affects over 5 million people worldwide. It is characterized by rapid, uncoordinated and uncontrolled contractions of the atria, the upper chambers of the heart, and keeps the heart from pumping blood efficiently. Until recently, approaches to AF treatment centered primarily on pharmacological therapy. In the United States, AF presents an immense health care and financial burden, affecting over 2 million people with annual medical expenditures in the 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. 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. AF is a common comorbidity of bradycardia. It has been shown that over 43% of patients implanted with a pacemaker with no documented supraventricular arrhythmia (SVA) before implant will develop some sort of SVA an average of one year post-implant(b).

In addition to its AFx(TM) feature set, other key Identity pacemaker therapeutic features include:

Beat-by-Beat(TM) AutoCapture(TM) Pacing System(1) - designed to continuously monitor evoked response following ventricular pacing to ensure capture on every paced beat, while delivering the minimum amount of energy required for capture, thereby helping optimize device longevity. In the event of noncapture, the algorithm delivers a high-output back-up safety pulse.

Advanced Hysteresis response - allows the user to respond to sudden intrinsic rate drops with an elevated pacing rate. The feature also expands the programmability of traditional hysteresis, allowing the user to program the frequency and duration that the device searches for intrinsic rhythm.

Noninvasive Programmed Stimulation (NIPS) - allows the clinician to perform different types of EP testing using only the implanted pacemaker.

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. The Company does not undertake any objective to update any statements in this release.

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.

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

(b) Garrigue S. et al. Arch Mal Coeur 1996; 89: 873-81.

(1) Only available from St. Jude Medical

(2) Only available from St. Jude Medical
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Publication:Business Wire
Geographic Code:1USA
Date:Nov 1, 2001
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