logo
Share SHARE
FONT-SIZE Plus   Neg

Medtronic Says FDA OKs Expanded Indication For Cardiac Resynchronization Therapy

Medtronic, Inc. (MDT) said that the FDA approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator, or CRT-D, devices. The expanded indication includes New York Heart Association Class II heart failure patients with a left ventricular ejection fraction of less than or equal to 30 percent, left bundle branch block, and a QRS duration greater than or equal to 130 milliseconds.

The company specified that the FDA's decision for the expanded indication rests on data from the pivotal REVERSE and landmark RAFT clinical trials, which demonstrated that CRT-D can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates.

With today's approval, the advanced therapy can now be used earlier, in a mildly symptomatic heart failure patient population, potentially improving survival, reducing hospitalizations, and preventing disease progression.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Delta Air Lines Inc. (DAL) pilots, represented by the Air Line Pilots Association International, are picketing on Friday at several airports across the country. The pilots said the picketing was to raise the sense of urgency in ongoing contract negotiations. The negotiations between the pilots... Charter Communications, and its recently acquired subsidiary Time Warner Cable, have been regularly overcharging its consumers to a tune of $7.2 million per year, according to a report from the U.S. Senate's Permanent Subcommittee on Investigations. According to the report, Time Warner Cable over-billed... Popular photo sharing network Instagram is adding a new translation button on its pages, so that the global crowd can read and enjoy the captions and comments given for the photographs uploaded. The new update will be available from next month onward.
comments powered by Disqus
Follow RTT