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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 advisory panel unanimously agreed that Johnson & Johnson MedTech's V-Wave Ventura interatrial shunt's risks outweigh ...
J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the ...
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 ...
Panelists considered the technology relatively safe but weren’t swayed by the “statistical gymnastics” needed to find a ...
The outside advisors analyzed the results of the RELIEVE-HF pivotal trial, which randomized 508 patients to either receive ...
Left Right & Center is for listeners who feel like people on the other side of the political divide are on Mars. David Greene pieces together the big picture by inviting people from the left and the ...
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