Caltech Startup Receives FDA Clearance for Heart Health Diagnostic

Heart failure is one of the leading causes of hospitalization among older adults in the United States, with over half a million new cases being recorded each year. Half of these individuals will die within five years of developing the disease.

Heart failure can be successfully prevented and managed through lifestyle, diet, and medication changes. Still, as much as 30 percent of affected people are unaware of having developed the condition until their health has been seriously impacted.

A health care startup founded by researchers from Caltech hopes to make heart failure diagnosis more straightforward and accessible, potentially changing the course of the disease for many people.

The company, Ventric Health, announced this week that it has received clearance from the Food and Drug Administration (FDA) to sell Vivio®, a device that can noninvasively detect signs of heart failure.

The device and the company are an outgrowth of research conducted at Caltech by Mory Gharib (PhD '83), Ventric Health co-founder and the Hans W. Liepmann Professor of Aeronautics and Medical Engineering. In 2017, Gharib announced that he and researchers in his lab had developed a smartphone app that could assess heart health using the phone's camera.

During that research effort, Alessio Tamborini, a postdoctoral scholar in medical engineering, also began working on an arm cuff to monitor a patient's pulse. That cuff was coupled with software containing a machine-learning algorithm that detects pulse characteristics associated with heart failure.

"This is a continuation of our earlier work," says Gharib, the Booth-Kresa Leadership Chair and director of Caltech's Center for Autonomous Systems and Technologies, and director of the Graduate Aerospace Laboratories. "But with a revolutionary jump from being a qualitative device to a quantitative device that can identify not just heart failure in a patient, but degrees of heart failure."

Vivio works by deducing the patient's left ventricular end diastolic pressure (LVEDP)—the pressure that builds in the left ventricle just before the aortic valve opens to let blood flow out into the body's arteries. In patients with heart failure, the heart must work much harder to pump blood, and the LVEDP is greatly increased. In a healthy patient, the LVEDP is around 2 mm of mercury. In a patient with total heart failure, it can be as high as 50 mm of mercury.

Direct measurement of LVEDP will give a clear indication of a patient's heart health, but it is an invasive procedure, requiring outpatient surgery to insert a catheter into the heart. To teach their device to measure it indirectly, the researchers trained the algorithm with LVEDP and pulse data taken from patients with varying levels of heart failure. Given a sufficient level of training, the algorithm learned to recognize high LVEDP by observing only pulse data taken from the arm cuff.

Now that Ventric Health has received FDA clearance to sell Vivio, Gharib says the team is working to deploy the devices to medical groups and medical centers, where they could be used to routinely assess incoming patients' heart health.

Gharib adds that Caltech is an ideal place for this kind of innovation to flourish—starting with basic research conducted by graduate students. Indeed, some of his students helped co-found Ventric and now work for the company.

"We're proud of our students' innovativeness and our Office of Technology Transfer and Corporate Partnerships," he says. "We don't just keep inventions at home sitting on the shelf. We are trying to get them out into the world and to have a societal impact."