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
Sign up for a free trial to see the rest of the stories you've been missing.
April 20, 2015
07:29 EDTHTWRCanaccord would be buyers of Thoratec following favorable ISHLT
Subscribe for More Information
07:26 EDTHTWRHeartWare weakness a buying opportunity, says Canaccord
Subscribe for More Information
April 16, 2015
09:52 EDTHTWRThoratec comments on HeartMate II data in ENDURANCE therapy trial
Subscribe for More Information
08:53 EDTHTWRBofA/Merrill medical technology analysts hold analyst/industry conference call
Subscribe for More Information
05:32 EDTHTWRHeartWare achieves primary endpoint in ENDURANCE clinical trial
Subscribe for More Information
April 11, 2015
14:10 EDTHTWRLeerink medical devices analyst holds an analyst/industry conference call
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