A clinical trial evaluating whether the device can predict heart failure–the technical term is “decompensated heart failure”–is under way and nearly complete, Corventis says. Heart-failure decompensation is the leading cause of hospitalization in Medicare patients, with more than a million U.S. hospitalizations a year costing tens of billions of dollars. “The projections are that if you can do remote monitoring for heart failure, it would save $20 billion in hospitalizations each year,” says Topol.
While scientists know that the device measures fluid accurately, it’s not yet clear whether having access to this information will ultimately reduce the incidence of hospitalization. This issue has plagued other cardiac monitoring devices, which accurately detected cardiac abnormalities but in the end failed to significantly improve clinical outcomes. “Intuitively, it’s really very exciting, but we still have to prove it,” says Topol. “But at least now there is a technology where you could see that the possibility is emerging.”
The company is also conducting a clinical trial to see if the sensor can diagnose sleep apnea through changes in respiration and blood oxygen levels. (Corventis plans to integrate a blood oxygen sensor in a future version of the device.) A third trial–to determine whether the device can predict imminent heart attacks by detecting subtle changes in heart rate and rhythm–is set to begin later this year, Manicka says.
A second Corventis sensor under review by the FDA will do more fine-grained capture of heart-rhythm disturbances. This device could detect subtle changes in heart patterns suggestive of arrhythmias such as atrial fibrillation, which is associated with increased stroke risk and is diagnosed in 835,000 Americans each year.
With these kinds of small, unobtrusive wireless health sensing and analytic technologies emerging, “we’ve never had more exciting innovation in wireless medicine. It’s extraordinary,” Topol said at a recent conference. In a later interview, he added that wireless sensing could transform how many diseases are treated. “Someday, this will give the ability to transform one’s home into an [intensive-care unit], with continuous vital-sign measurements. There is a lot going on here, and there is the potential that it will transform health care.”