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ShockGuard technology receives FDA and CE mark approval

ShockGuard technology receives FDA and CE mark approval

St Jude Medical announced that it has received FDA and CE mark approval for its ShockGuard technology. The technology, which can be used with new Unify cardiac resynchronisation therapy defibrillators (CRT-D) and Fortify implantable cardioverter defibrillators (ICD), is designed to reduce inappropriate and unnecessary shocks for patients with these devices.

Unify and Fortify 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, Piedmont Heart Institute, Atlanta, USA. “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 implantable cardioverter defibrillators 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% 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%, with appropriate shocks for ventricular tachycardia and ventricular fibrillation reduced by 41% and inappropriate shocks for all other conditions, including supraventricular tachycardia, reduced by 80%.

“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 ventricular tachycardia and ventricular fibrillation episodes, which may be associated with worse outcomes,” said Eric S Fain, president, 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.”

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