Assura Implantable Defibrillators Designed to Reduce Inappropriate Shocks
St. Jude Medical Inc.'s Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) feature SecureSense RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices.
The SecureSense RV Lead Noise Discrimination algorithm is expected to assist physicians by providing advanced alerts as well as more proactively lowering the risk of lead-related complications through its ability to automatically withhold tachycardia therapy in the presence of lead noise (over-sensing of electrical signals). The technology differentiates lead noise from true ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes that require life-saving therapy.
In addition, ShockGuard technology features specific programming that distinguishes between rhythms that require defibrillation therapy and those that do not, such as benign arrhythmias. 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. Using ShockGuard with DecisionTx programming, 98.5 percent of patients are projected to be free of inappropriate shocks after one year.
The Assura family of devices will allow St. Jude Medical to continue to offer industry leading 40 J in delivered energy, in addition to Tailored Therapy features that give physicians more options for customizing therapy for patients, such as DeFT Response technology. The DeFT Response technology feature is designed to meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy. The Assura product portfolio includes the Quadra Assura CRT-D, the Unify Assura CRT-D and the Fortify Assura ICD.
St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) approval of its Assura portfolio in May 2012.
For more information: www.sjm.com
1. Daubert, JP, et al. Inappropriate Implantable Cardioverter-Defibrillator Shocks in MADIT II: Frequency, Mechanisms, Predictors, and Survival Impact. JACC. 2008;51(14):1357-1365.