Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - March 20, 2007

St. Jude Medical Announces FDA Approval of First U.S. Heart Failure Device with AF Suppression Technology

Atlas II+ HF CRT-D Helps Physicians Manage Atrial Fibrillation, Which Commonly Accompanies Heart Failure

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of a new cardiac rhythm management device designed to help physicians manage heart failure (HF) patients, including patients who have or may develop atrial fibrillation (AF).

The AtlasŪ II+ HF CRT-D (cardiac resynchronization therapy defibrillator) is the first U.S. heart failure device to offer the AF Suppression(TM) algorithm. This proprietary algorithm helps maintain control of the heart's atrial rhythm by pacing slightly faster than the patient's natural heart rate. The AF Suppression algorithm has been clinically proven to reduce the AF burden (the percentage of days with AF symptoms) in previous studies.

Heart failure and atrial fibrillation - considered the two new epidemics of cardiovascular disease - commonly occur together. About 40 percent of patients who have HF also experience AF, according to the 2003 Framingham Heart Study, and the incidence of AF appears to increase as the severity of HF increases. Nearly 5 million Americans have HF, according to the American Heart Association.

Heart failure patients with AF present significant challenges, such as further reduction in cardiac output, potential loss of biventricular pacing (if the abnormal rhythm is conducted rapidly or irregularly to the ventricles) and increased risk of stroke. Managing these conditions can be complicated by the fact that many patients already are on extensive drug regimens, and they often have other health issues.

"The AF Suppression algorithm provides me with an effective non-pharmacological method for treating my heart failure patients who have AF," said Steven Greenberg, M.D., of the Cardiac Arrhythmia and Pacemaker Center, in Roslyn, N.Y. "With this novel device, I can treat heart failure, while suppressing AF."

The new Atlas II+ HF CRT-D also offers the company's QuickOpt(TM) timing cycle optimization feature, a programmer-based optimization for people with CRT-D devices and traditional implantable cardioverter defibrillators (ICDs) that helps physicians quickly program the device's timing so it delivers optimal therapy to patients. The QuickOpt feature produces results that are comparable to echocardiography (or echo, the current industry standard), but is significantly less costly and time-consuming. A QuickOpt timing cycle optimization procedure takes less than two minutes, while a typical echo procedure takes between 30 and 120 minutes and requires manual interpretation by a technician.

The QuickOpt feature electrically characterizes the conduction properties of the heart and uses an exclusive algorithm to calculate the optimal timing values. This allows for efficient and frequent optimization during routine device follow-up visits.

Other features of the Atlas II+ HF CRT-D are designed to help physicians manage difficult-to-treat conditions:
  • DeFT Response(TM) technology and unsurpassed energy output (36 J delivered energy, 42 J stored energy) help physicians manage the unpredictably high defibrillation thresholds that affect as many as one in eight heart failure patients.
  • Remote monitoring enables device information to be downloaded and accessed from any computer with Internet access, enabling routine follow-up to be conducted from the convenience of the patient's home.
"Because heart failure patients often have other health issues, we have added the AF Suppression algorithm to the Atlas II+ HF CRT-D to help physicians better manage this complicated comorbidity," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "This technology provides another tool for physicians to tailor treatment to specific and complex patient conditions."

About the size of a pocket watch, a CRT-D device provides cardiac resynchronization therapy (CRT) for patients with heart failure, a progressive condition that weakens the heart, causes the lower chambers of the heart (ventricles) to beat out of sync, and results in the heart's inability to effectively pump an adequate supply of blood to the body. CRT - available through an ICD or a pacemaker - provides a better quality of life by resynchronizing the beating of the heart's lower chambers. Approximately 550,000 new patients are diagnosed with HF each year in the United States, according to the American Heart Association.

Atrial fibrillation (also called AF or A Fib) is the most common abnormal heart rhythm. It is a very fast, uncontrolled heart rhythm caused when the upper chambers of the heart (the atria) quiver instead of beat. Because the pumping function of the upper chambers isn't working properly, the blood is not completely emptied from the heart's chambers, resulting in reduced cardiac output.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 11,000 people worldwide. For more information, please visit www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's Annual Report on Form 10-K filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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