Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - April 14, 2011

St. Jude Medical Announces Approval of ShockGuard(TM) Technology with New DecisionTx(TM) Programming for Unify and Fortify Implantable Defibrillators

ShockGuard Technology with new DecisionTx programming reduces inappropriate shocks while ensuring effective defibrillation when needed

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) and European CE mark approval of its ShockGuard™ technology. The technology, which can be used with new and existing Unify™ cardiac resynchronization therapy defibrillators (CRT-Ds) and Fortify™ implantable cardioverter defibrillators (ICDs), is designed to reduce inappropriate and unnecessary shocks for patients with these devices.

The Unify CRT-D and Fortify ICD with ShockGuard technology features DecisionTx™ programming that discriminates between rhythms that require defibrillation therapy and those that do not. The ShockGuard technology with DecisionTx programming offers advanced sensing technology designed to avoid sensing unwanted signals (T-waves) and more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks.

“The St. Jude Medical ShockGuard technology has been demonstrated to reduce inappropriate defibrillation therapy, while still ensuring that patients will receive the treatment needed for life-threatening ventricular arrhythmias,” said Thomas F. Deering, M.D., FHRS, FACC, FACP, CCDS, Piedmont Heart Institute in Atlanta, Ga. “This technology was based on real world data and analysis representing actual patient populations who receive implantable cardiac defibrillators.”

A retrospective analysis of the Advancements in ICD Therapy (ACT) registry, which enrolled more than 5,000 patients and allowed programming at the physician’s discretion, demonstrated that at the end of one year, 98.5 percent of patients with DecisionTx programming would be free of inappropriate shocks. In addition, the ACT registry analysis demonstrated a DecisionTx total shock reduction impact of 57 percent, with appropriate shocks for ventricular tachycardia (VT) and ventricular fibrillation (VF) reduced by 41 percent and inappropriate shocks for all other conditions, including supraventricular tachycardia (SVT), reduced by 80 percent.

“The goal for this innovative technology was to address one of the most significant clinical challenges facing physicians today, how to reduce not only instances of inappropriate therapy, but also reduce shocks for VT and VF episodes, which may be associated with worse outcomes,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “DecisionTx represents the first step of our new ShockGuard technology and further supports our commitment to deliver more control to physicians worldwide.”

An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). Approximately 325,000 people per year in the U.S. die suddenly of SCD.

A CRT-D device resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients, and provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure. Studies have shown that CRT (cardiac resynchronization therapy) can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. About five million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.

The Unify CRT-D and Fortify ICD have been fully-launched in Europe and the U.S.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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 Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended January 1, 2011. 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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