FDA approves HeartWare’s bridge-to-transplant system

The FDA has approved the HeartWare Ventricular Assist System to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.

The HeartWare Ventricular Assist System includes an implantable pump with an external driver and power source. It is designed for use inside or outside the hospital. While other available left ventricular assist devices (LVADs) require components to be placed in the abdomen, the HeartWare system can be implanted in the chest near the heart, allowing for implantation in smaller adults or patients unable to have an implant in the abdomen, according to the FDA.

“For patients awaiting a donor heart, the HeartWare System provides a new treatment option,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.

In April, the FDA’s Circulatory System Device Advisory Committee recommended on a 9-to-2 vote approval of the device, which is manufactured by Framingham, Mass.-based HeartWare. The FDA based its approval on data from the ADVANCE clinical trial, which compared outcomes from 137 advanced heart failure patients using the HeartWare system with outcomes from similar patients followed by the Interagency Registry for Mechanically Assisted Circulatory Support.  The registry collects information on patients implanted with approved mechanical circulatory support devices.

Survival outcomes were comparable in the HeartWare LVAD and registry groups, the FDA reported in its approval notification. Key serious adverse events such as infection and stroke were assessed in the clinical trial and compared with adverse events discussed in the scientific literature based on clinical trials or postmarket studies of other LVADs.

Although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device, according to the FDA.