The product cleared for sale by the Food and Drug Administration is the first to make a marked improvement in the number of heart-failure patients who respond to treatment since the synchronization devices were approved more than a decade ago, Steinhaus said. Some doctors don’t refer their patients for evaluations needed to get the devices, and others don’t often implant them, for fear they may not help the patients feel better, he said.
“It’s really the first time we can say we’ve made a difference in response rates,” he said. “Nobody wants to go through the procedure and put this in a patient who isn’t going to feel better, even though we may be helping by stemming the progression of the disease. We expect this to become the standard of care in the United States.” year earlier, the Minneapolis-based company said in a statement