The US Food and Drug Administration (FDA) is notifying physicians of a Class I recall of unimplanted HeartWare ventricular assist device (VAD) implant kits, initiated voluntarily by the company in ...

Thousands of HVADs could have faulty battery cells. Nancy Crotti HeartWare International is recalling more than 18,000 batteries for ventricular assist devices it sold between 2013 and 2015, the ...

Both the agency and its panel of advisors had been concerned about an annual 9.2% rate of pump-related thrombus observed in the nonrandomized ADVANCE trial, which compared the HeartWare device ...

The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation, myocardial recovery, ...

HeartWare International ($HTWR) is now wielding a crucial weapon in its quest to gain FDA approval for its left ventricular assist device. A panel of experts has ...

The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after ...

(UPDATED) The HeartWare left ventricular assist device (LVAD) may now be used in the United States as a destination therapy in patients with end-stage heart failure who are not candidates for ...

The FDA today approved the HeartWare Ventricular Assist System — a left ventricular assist device — to support heart function and blood flow in patients with end-stage HF who are awaiting a heart ...

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. A congressional oversight subcommittee is investigating the ...

A clinical trial of HeartWare's newest LVAD has been paused, at the same time that St. Jude Medical's HeartMate 3 has won CE Mark. Nancy Crotti HeartWare International has put a clinical trial of its ...