A Houston company with a breakthrough heart health tech has received a green light from the FDA.

BiVACOR, a Houston-headquartered medical device company, has received FDA approval for its Total Artificial Heart (BTAH) IDE first-in-human early feasibility study (EFS). The BTAH device itself is designed to take over all function for patients with heart failure. The BTAH is roughly the size of a human fist, which means that, while it could support an active adult male, it may also fit many women and children.

Led by CEO Thomas Vassiliades, a former heart surgeon, BiVACOR is based on a system of magnetic levitation. “Our pump is just one moving impeller that sits in the middle of the housing where the blood is. Imagine an artificial heart — the container that has your blood — and the device spinning in the inside — basically a wheel spinning your blood to the rest of your body. The device is suspended by magnets — it's not touching anything,” Vassiliades told InnovationMap in a podcast earlier this year.

Because of that, BiVACOR could potentially last for a patient’s entire life with no wear — something, Vassiliades explains, is new to the field.

The EFS includes 10 hospitals enrolled as possible sites and is slated to begin in 2024. One location is Houston’s own Texas Heart Institute.

“I am eager to begin the BiVACOR Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” Joseph Rogers, CEO of the Texas Heart Institute, says in a press release. “The implantation of a TAH system is a potential treatment option for patients with heart failure who need support while on the heart transplant waiting list and for those who do not qualify for a transplant. The BTAH is designed to replace the function of the native heart completely. It is an impressive technology, and I am excited to see the potential of BTAH in treating patients with severe heart failure.”

BiVACOR’s chief medical officer is Texas Heart Institute cardiac surgeon William Cohn. He said that this EFS is a “critical milestone” for him and the BiVACOR team.

“This device will provide a unique approach to help patients currently with limited clinical options,” he explains.

The upcoming study is planned for biventricular heart failure patients who need a mechanical circulatory support device as a bridge to later transplantation. However, the team hopes that future studies will follow to chart the BTAH’s success with short-term and long-term destination therapy.