St. Jude Medical (NYSE:STJ) announced Tuesday that the U.S. Food and Drug Administration has approved the Assura line of implantable cardioverter defibrillators and cardiac resynchronization therapy devices.
The new devices reduce the potential for inappropriate shocking because the device has advanced algorithms that can discern between a real event requiring a life-saving therapy and one that occurs due to oversensing by the lead sensors.
“The Assura product portfolio offers new features that protect patients from unnecessary defibrillation therapy,” said Dr. Mark Coppess, of the Stern Cardiovascular Foundation in Memphis, Tennessee, in a St. Jude release. “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.”
A 2007 study published in the Journal of the American College of Cardiology found that abnormal sensing caused 20 percent of overall inappropriate shocking in ICDs.
“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 Fain, president of the St. Jude Medical Cardiac Rhythm Management Division, in a news release.
The Assura line of heart devices include theQuadra Assura CRT-D, the Unify Assura CRT-D and the Fortify Assura ICD.
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By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
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