Medical Devices

FDA approves Medtronic heart devices to treat mild heart failure symptoms

FDA, approvedMedtronic (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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