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
Yelp Inc. (YELP) on Monday posted a loss for the fourth quarter compared to a profit last year, as higher revenues were offset by increase in operating costs. Yelp said its Chief Financial Officer Rob Krolik was leaving the company. Yelp reported fourth-quarter loss of $22.2 million or $0.29 per share,... Twenty-First Century Fox Inc., (FOXA, FOX) on Monday reported a second-quarter profit that dropped from last year, hurt largely by lower revenues as strong cable and television advertising revenues were offset by lower filmed entertainment division. Earnings for the quarter trumped Wall Street estimates... Toy maker Hasbro Inc. (HAS) reported a profit for the fourth-quarter 2015 that grew about 3.5% from last year. Quarterly net revenues increased 13% from the prior year. Both earnings per share and revenue for the quarter beat analysts' expectations.
comments powered by Disqus
RELATED NEWS
Trade MDT now with 
Follow RTT