STAT+: What an abandoned heart failure trial says about ‘breakthrough’ devices that don’t reach patients

It wasn’t sure to be a slam dunk. By the time LivaNova launched a pivotal trial for its vagus nerve stimulator to treat heart failure in 2018, similar devices had shown mixed results. But the Food and Drug Administration had designated the device as a breakthrough, a label intended to speed promising technologies to patients with unmet needs: Maybe this would be the device to help heart failure patients when drugs weren’t enough.  Over the last decade, the FDA’s breakthrough device program has h...