St. Jude Medical received both FDA and European CE mark approval for its ShockGuard technology that prevents unnecessary defibrillation. ShockGuard is being introduced on the company’s Unify CRT-D and Fortify ICD’s and apparently can be activated on existing implants of these defibrillator models.
The Unify CRT-D and Fortify ICD with ShockGuard technology features DecisionTx(TM) 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.
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.
Company announcement: St. Jude Medical Announces Approval of ShockGuard(TM) Technology with New DecisionTx(TM) Programming for Unify and Fortify Implantable Defibrillators…
Product pages: Fortify ICD; Unify CRT-D