FDA, EU approve St. Jude's ShockGuard technology
St. Jude Medical’s ShockGuard technology, used with its Unify cardiac resynchronization therapy defibrillators (CRT-Ds) and Fortify ICDs to reduce inappropriate shocks, has gained a CE mark from the European Union and has been approved by the FDA.
The ShockGuard technology uses DecisionTx programming to help discriminate between rhythms that require defibrillation therapy and those that do not. The software uses sensing technology to avoid unwanted T-waves and provides more anti-tachycardia pacing options, which can help convert ventricular arrhythmias and help avoid shocks.
A retrospective review of Advancements in ICD therapy (ACT) registry data found that 98.5 percent of patients who were programmed with DecisionTx technology were free of inappropriate shocks at one year. Additionally, it was reported that use of DecisionTx could reduce shock by 57 percent, and appropriate shocks for ventricular tachycardia and ventricular fibrillation were reduced by 41 percent. Inappropriate shocks for other arrhythmias such as supraventricular tachycardia were reduced by 80 percent.
St. Paul, Minn.-based St. Jude said the Unify CRT-D and Fortify ICD have already been launched in Europe and the U.S.
The ShockGuard technology uses DecisionTx programming to help discriminate between rhythms that require defibrillation therapy and those that do not. The software uses sensing technology to avoid unwanted T-waves and provides more anti-tachycardia pacing options, which can help convert ventricular arrhythmias and help avoid shocks.
A retrospective review of Advancements in ICD therapy (ACT) registry data found that 98.5 percent of patients who were programmed with DecisionTx technology were free of inappropriate shocks at one year. Additionally, it was reported that use of DecisionTx could reduce shock by 57 percent, and appropriate shocks for ventricular tachycardia and ventricular fibrillation were reduced by 41 percent. Inappropriate shocks for other arrhythmias such as supraventricular tachycardia were reduced by 80 percent.
St. Paul, Minn.-based St. Jude said the Unify CRT-D and Fortify ICD have already been launched in Europe and the U.S.