Category: HeartWare International Inc.
Results from Thoratec's Roadmap study of its HeartMate II implantable heart pump in less-sick heart failure patients shows significant benefit over optimal medical therapy alone.
Higher-than-expected stroke rates reported in a pair of studies of HeartWare's implantable heart pump this week spook investors, pushing HTWR share prices down more than 8%.
Here's a look at some of the top regulatory stories for medical device companies this week: FDA finalizes fast-track approval for medical devices; CardiAQ Valve wins FDA nod for mitral valve trial; HemCon enters Chinese wound care market; HeartWare wins Health Canada nod for BTT heart pump; Another FDA warning letter for Hospira
Canadian regulators approved HeartWare International's ventricular assist device as a bridge to heart transplant for patients with end-stage heart failure.
HeartWare International has issued an urgent recall for certain computerized controllers for its ventricular assist devices over concerns that they may malfunction and cause the heart pump to stop.
HeartWare International (NSDQ:HTWR) has issued an urgent recall for certain computerized controllers for its ventricular assist devices over concerns that they may malfunction and cause the heart pump to stop.
HeartWare International's preliminary sales numbers for the 4th quarter beat expectations as it launches a thoracotomy trial for its implantable heart pump.
Thoratec's 3rd-quarter earnings plunge nearly 85% as sales decline more than 16%, raising fears that the left ventricular-assist device market is in a slump that could persist into 2015.
Thoratec (NSDQ:THOR) yesterday said its 3rd-quarter profits plunged some 85%, missing forecasts, and dimmed its outlook for the rest of the year.