WASHINGTON (AP) — The Food and Drug Administration says a heart device from Boston Scientific appears effective for a new group of patients, though questions remain about the company's study of the device.
Boston Scientific has asked the FDA to approve its heart rhythm devices to treat mild heart failure, a new use that could expand the market for the devices by millions of patients.
But in an online review, the FDA suggests the patients Boston Scientific studied were less healthy than typical patients with the condition. As a result, the true benefits of the device could have been overstated by the study, according to the agency's online posting.
The FDA will ask a panel of cardiologists on Thursday to weigh in on the device.
