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Interatrial Shunt to Go Before FDA Panel for Heart Failure Indication
Sponsor seeks approval based on sliced and diced data ...
An FDA advisory panel unanimously agreed that Johnson & Johnson MedTech's V-Wave Ventura interatrial shunt's risks outweigh ...
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 ...
Panelists considered the technology relatively safe but weren’t swayed by the “statistical gymnastics” needed to find a ...
Brian Fahey explains how Adona Medical uses heat to adjust its novel shape memory nitinol implant without harming heart ...
MedPage Today on MSN
FDA panel on interatrial shunt for heart failure: It's a hard no
Ventura transcatheter device found no support on efficacy at a critical FDA advisory commi ...
An FDA panel unanimously rejected J&J's V-Wave Ventura heart shunt, citing risks outweighing benefits despite safety data.
Background. Little is known regarding the optimal treatment of ventriculoperitoneal (VP) shunt infections in adults. Our aim was to assess the efficacy of treatment strategies and to identify factors ...
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