FDA gives go-ahead for Levacor trial
This article was originally published in Clinica
Executive Summary
WorldHeart is to begin a US bridge-to-transplant study of its levitating ventricular assist device (VAD), Levacor, after receiving conditional study approval from the FDA. Salt Lake City, Utah-based WorldHeart must first pass some additional data to the FDA – it has 45 days in which to do so – but the study may begin upon the agency's receipt of clinical centre institutional review board approvals. The trial will enrol 200 subjects, and an interim analysis of the first 150 subjects is planned. The study has been assigned CMS category B2, which makes insurance reimbursement possible.
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