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
Netflix has announced the new arrivals in its streaming video lineup in the month of December that include many Christmas-themed shows and films to choose from. The holiday season will also see some great movies disappearing from the platform. Shares of easyJet Plc were gaining around 6 percent in the morning trading in London after the airline reported higher revenues, traffic and capacity in its fiscal 2017, despite weak profit. Looking ahead, the company projects capacity growth in fiscal 2018. Following his twelve-day trip to Asia, President Donald Trump announced Monday the U.S. is putting North Korea back on a list of state sponsors of terrorism. Trump announced the move in comments ahead of a Cabinet meeting and said his administration would also be ramping up sanctions on North Korea.
comments powered by Disqus
Follow RTT