Technology | May 11, 2012

FDA Clears Assura Implantable Defibrillators Designed to Reduce Inappropriate Shocks

May 11, 2012 — St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) approval of its Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new implantable defibrillators 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 Assura product portfolio offers new features that protect patients from unnecessary defibrillation therapy,” said Mark A. Coppess, M.D., at the Stern Cardiovascular Foundation in Memphis, Tenn. “The SecureSense RV Lead Noise Discrimination algorithm is important because it provides a way to distinguish over-sensing due to lead issues from real episodes that warrant life-saving treatment.”

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.[1]

“For some patients, the fear of receiving a shock can either prevent them from receiving a potentially life-saving device, or cause anxiety that reduces their quality of life once they receive the device. These devices directly address this patient concern and provides physicians additional tools to manage individual patient needs,” said Eric S. Fain, M.D., president of the St. Jude Medical cardiac rhythm management division. “The launch of the Assura family of implantable defibrillators further strengthens our cardiac rhythm management product portfolio and provides physicians with the broadest range of options to deliver safe, effective therapy.”

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.

For more information: www.sjm.com

Reference:
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.

Related Content

EpiAccess System, EpiEP, Mount Sinai New York, epicardial access
News | Ablation Systems| August 22, 2016
August 22, 2016 — The Mount Sinai Hospital is the first site in the New York metropolitan area to pioneer a new appro
warfarin, long-term stability, atrial fibrillation, DCRI study, Sean Pokorney
News | Antiplatelet and Anticoagulation Therapies| August 16, 2016
August 16, 2016 — Warfarin prescribed to prevent strokes in...
Sponsored Content | Videos | Inventory Management| August 15, 2016
Pacemakers, stents and bandages — keeping tracking of what is on hand and accurately capturing charges can be a chall
News | EP Lab| August 12, 2016
August 12, 2016 — Electrophysiology ablation navigation system company Stereotaxis Inc.
Absorb, bioresorbable stent, FDA approval, FDA approves, FDA clears, most popular content, most popular stories, DAIC

The FDA clearance of the first bioresorbable stent, the Abbott Absorb, the first week of July has been the most popular story so far for all of 2016. It is the first fully dissolving stent approved for the U.S. market and many experts say this technology could be a paradigm shift in coronary and peripheral therapies in the coming years as the technology improves. 

Feature | August 05, 2016 | Dave Fornell
 
Watchman, left atrial appendage closure, LAA occluder

An illustration of a Watchman transcatheter LAA occluder being implanted.

Feature | Left Atrial Appendage (LAA) Occluders| August 01, 2016 | Dave Fornell
Patients with atrial fibrillation (AF or Afib) are high risk for stroke due to the formation of thrombus emboli in th
pros and cons of new anticoagulation therapies, anticoagulants, dabigatran, Pradaxa, novel oral anticoagulants, NOACs, rivaroxaban, Xarelto, apixaban, Eliquis
Feature | Antiplatelet and Anticoagulation Therapies| July 26, 2016 | Heidi Olson, Pharm.D
With the recent introduction of several novel oral...
Alere, INRatio PT/INR Monitor, voluntary recall, FDA
News | Blood Testing| July 12, 2016
July 12, 2016 — Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc.
Overlay Init