New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
November 20, 2012
14:45 EDTHTWRHeartWare confirms FDA approval for HeartWare Ventricular Assist System
HeartWare International confirmed that it has received approval from the United States Food and Drug Administration for the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. The HeartWare System is currently the leading ventricular assist device implanted in patients outside of the United States, having received CE Marking in the European Union in 2009, and Australian Therapeutic Goods Administration approval in 2011. In other clinical development for the HeartWare Ventricular Assist System, HeartWare has completed enrollment of a 450-patient destination therapy study at 50 U.S. sites. The final patients were implanted in May, with a two-year, primary endpoint follow-up period. HeartWare has requested a Continued Access Protocol allocation for destination therapy from the FDA. The company said, "Our team is positioned to commence the commercial rollout of the HeartWare System immediately, first facilitating broad use by the 50 U.S. hospitals that participated in our clinical studies, and then with training and expansion to additional U.S. hospitals."
News For HTWR From The Last 14 Days
Check below for free stories on HTWR the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
September 17, 2014
11:41 EDTHTWRLeerink medical devices analyst holds an analyst/industry conference call
Subscribe for More Information
September 15, 2014
07:21 EDTHTWRHeart Failure Society of America to hold annual meeting
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use