HeartWare LVAD receives FDA approval for heart transplant patients

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 transplant, according to a press release.

The agency based approval on data from the ADVANCE trial that compared outcomes from 137 advanced HF patients using the HeartWare System (HeartWare Inc.) with outcomes from similar patients followed by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).

Results showed comparable survival outcomes in the HeartWare LVAD and INTERMACS groups. The clinical trial also assessed serious adverse events such as infection and stroke and compared these adverse events with those discussed in the scientific literature based on clinical trials or post-market studies of other LVADs. Rates of most key adverse events were comparable, although the risk for stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device, the release states.

In April, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 9-2 to recommend approval of the device.

The approval marks the first time the FDA has approved an LVAD using registry data as a control.

“Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release.

“For patients awaiting a donor heart, the HeartWare System provides a new treatment option.”

The HeartWare LVAD includes an implantable pump with an external driver and power source and is designed for use both inside and outside the hospital.