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 ...

HeartWare International is voluntarily recalling an unspecified number of LVADs due to the possibility of electrical faults that could stop the pump should the driveline become contaminated. The ...

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 ...

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 left ventricular assist device (LVAD) appears to have potential as a destination therapy in patients with end-stage heart failure who are not candidates for cardiac transplantation, at ...

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 ...

Medtronic has stopped the sale of its Heartware Ventricular Assist Device (HVAD) system and is advising physicians cease implanting the device because problems with an internal pump can lead to death ...

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 ...

Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small ...

The HeartWare system is now off the table for left ventricular assist device (LVAD) candidates with advanced heart failure, the FDA announced. Medtronic is halting the global distribution and sale of ...

(Reuters) – The U.S. Food and Drug Administration said it has approved a heart pump made by HeartWare International Inc’s that supports blood flow in people with failing hearts who are awaiting a ...