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
Kik Interactive Inc., the parent of chat app Kik, said it will launch a new cryptocurrency or token called Kin for use in everyday digital services, such as chat, social media and payments. Kik said it has decided to propose a new ecosystem of digital services that will be truly open and decentralized, and will start with a new cryptocurrency. Several companies have pulled advertisements from Sean Hannity's Fox News show after he continued to promote a conspiracy theory about Democratic National Committee staffer Seth Rich's death. Hannity has come under fire for spreading a conspiracy theory linking Rich's killing to Wikileaks. Best Buy Co., Inc. reported lower profit in its first quarter on the absence of last year's CRT settlement proceeds. However, earnings per share topped market estimates significantly with higher comparable sales. Looking ahead, for the second quarter, the company projects higher comparable sales, and also lifted fiscal 2018 forecast for higher growth.In pre-market, shares were gaining 11.9 percent
comments powered by Disqus
Follow RTT