HeartWare’s LVAD Gets FDA PMA Nod

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

In short

The U.S. FDA has approved the HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.


Just over a week ago we were commenting on HeartWare’s financial reports from last quarter, noting that the company was experiencing continuing and indeed widening losses as it trudged along the road to FDA approval, spending its dollars on R&D and clinical support for the product while revenues were limited to those coming from outside the U.S. as domestic trials reached their conclusions. That article can be found here.

Now the company has the U.S. approval it needs, as confirmed in this FDA release issued on November 20th.

This is progress because…

…unlike other LVADs, which require components to be placed in the abdomen, the HeartWare System is small enough to be implanted in the chest near the heart, allowing for implantation in smaller adults or patients unable to have an implant in the abdomen.

The FDA approved the HeartWare LVAD based on data from a clinical trial known as the ADVANCE trial in which survival outcomes were comparable between the HeartWare LVAD and its comparator group, which was, for the first time for FDA, registry data (see comments below).

Interestingly, 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.

FDA comments

“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.

“Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators. For HeartWare, registry data directly facilitated the development and availability of this new device,” said Foreman.

Source: FDA