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St. Jude Assura defibrillators get FDA clearance

9 May 2012

The US Food and Drug Administration (FDA) has approved St. Jude Medical's Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).

An ICD treats potentially lethal, abnormally fast heart rhythms that can lead to sudden cardiac death (SCD), while a CRT-D device resynchronises the beating of the heart's lower chambers and provides back-up treatment for SCD.

The new implantable defibrillators feature SecureSense RV lead noise discrimination, an algorithm that expands the company's ShockGuard technology and offers sensing options designed to reduce the incidence of inappropriate shocks.

The SecureSense RV algorithm will assist physicians by providing advanced alerts, as well as proactively lowering the risk of lead-related complications through its ability to automatically withhold tachycardia therapy in the presence of lead noise.

"The Assura product portfolio provides new features that protect patients from unnecessary defibrillation therapy."

The DecisionTx programming feature of the Assura defibrillators provides advanced sensing technology designed to avoid sensing unwanted and antitachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high-voltage shocks.

Mark Coppess, the Stern Cardiovascular Foundation spokesperson, said the Assura product portfolio provides new features that protect patients from unnecessary defibrillation therapy.

"The SecureSense RV lead noise discrimination algorithm is important because it provides a way to distinguish oversensing due to lead issues from real episodes that warrant life-saving treatment," Coppess added.

St. Jude Medical's cardiac rhythm management division president Eric Fain said that 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 provide physicians with additional tools to manage individual patient needs," Fain added.

"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."