Medtronic (NYSE:MDT) announced Tuesday that the U.S. Food and Drug Administration has approved its heart devices for treating people who suffer from mild symptoms of heart failure through an expanded indication.
Previously, cardiac resynchronization therapy with implantable cardioverter defibrillator devices was approved only for those who showed moderate to severe symptoms. Under the current expanded approval, roughly 200,000 Americans are eligible to be treated based on certain medical parameters.
The approvals were based on two pivotal studies that Medtronic conducted to show that the CRT-D therapy is able to reduce deaths and hospitalization rates among this patient population.
The Minnesota device maker also seeks to do a post-approval study to demonstrate the clinical benefits of such therapy among patients who suffer from mild symptoms of heart failure, the company said in a news release.
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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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