HEALTHJun 24 · 08:30 UTCSTAT NEWSKatie Palmer

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

LivaNova's VITARIA vagus nerve stimulator for heart failure, designated a FDA breakthrough device, failed to meet trial success criteria after enrolling 500 patients. The FDA's breakthrough device program, aimed at accelerating innovative treatments, did not ensure the device's market success.

Nexus surfaces and summarizes. The full story lives at the source.

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LivaNovaorganizationVITARIAtopicFood and Drug Administrationorganizationvagus nerve stimulatortopicheart failuretopicbreakthrough device programtopic

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