Most high-risk heart devices now approved to be implanted in patients have gone through a speedy “supplement” review because they’re considered to be upgraded versions of older devices with only minor modifications, according to a new study conducted by Brigham and Women’s Hospital researchers. The research, published last Tuesday in the Journal of the American Medical Association, found the US Food and Drug Administration approved 77 applications for new cardiac implantable electronic devices, such as pacemakers and defibrillators, and 5,829 supplements for updated devices from 1979-2012, with ultimately 50 updated devices being approved for every new one.
What troubled the researchers was that 37 percent of the approved supplements involved a change to the device’s design, and many were approved without any data to show that the new design was safe and effective.
Two years ago, the FDA issued a recall for leads used in certain Riata defibrillators because the leads’ insulation wore out too quickly, causing the device to malfunction. The recalled leads were approved through the speedier supplement review, said study author Dr. Aaron Kesselheim, an assistant professor of medicine at Brigham and Women’s. “We didn’t look . . . at whether devices approved under a supplement review were more likely to be withdrawn from the market,” Kesselheim said. “We wanted to educate patients and physicians to the fact that this approval exists.”