Millions of Americans receive implanted cardiovascular devices such as pacemakers and stents, but many of the devices are not subjected to rigorous safety and effectiveness research before being approved for use, according to a study. It's common for such devices to receive Food and Drug Administration approval based on information from only a single study, which "raises questions about the quality of data on which some cardiovascular device approvals are based," said the authors. Such scant data do not constitute the kind of high-quality evidence for safety and efficacy that doctors and consumers expect, the authors said.
