Category: HeartWare International Inc.
HeartWare International issues a Class I recall for pump driveline splice kits used with its left ventricular assist device.
Shares of Thoratec rise after the heart pump maker beats Wall Street's forecast with its 1st-quarter results, but arch-rival HeartWare slides after just meeting The Street's bottom line.
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.