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

LivaNova's pivotal trial for its VITARIA vagus nerve stimulator, intended to treat heart failure, was abandoned in 2022 after enrolling 500 patients, half of its planned maximum. The device had received a breakthrough designation from the Food and Drug Administration (FDA) in 2018, a label meant to accelerate the availability of promising technologies for unmet medical needs. Despite the FDA's designation and an adaptive trial design that allowed for early stopping based on data checkpoints, an independent data and safety monitoring committee determined in 2022 that the trial signals were not strong enough to warrant stopping. This trial's outcome contrasts with the FDA's breakthrough device program, which has facilitated the market entry of nearly 200 innovative products over the past decade. The trial's design aimed to allow LivaNova and its investigators to act swiftly by assessing progress in batches of 100 patients, but ultimately, the device did not demonstrate sufficient efficacy to proceed.