The outside advisors analyzed the results of the RELIEVE-HF pivotal trial, which randomized 508 patients to either receive ...
J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions. Following the vote, a J&J spokesperson ...
The FDA’s Circulatory System Devices Panel voted not to recommend approving use of an interatrial shunt to improve heart failure symptoms and prognosis.In a 0-15 vote, the committee determined risk ...
An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.
Brian Fahey explains how Adona Medical uses heat to adjust its novel shape memory nitinol implant without harming heart ...
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