MedPage Today on MSN
Interatrial Shunt to Go Before FDA Panel for Heart Failure Indication
Ventura's permanent interatrial shunt was designed to shunt blood from the left to right atrium to improve symptoms in ...
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 ...
Brian Fahey explains how Adona Medical uses heat to adjust its novel shape memory nitinol implant without harming heart ...
Panelists considered the technology relatively safe but weren’t swayed by the “statistical gymnastics” needed to find a ...
An FDA panel unanimously rejected J&J's V-Wave Ventura heart shunt, citing risks outweighing benefits despite safety data.
MedPage Today on MSN
FDA panel on interatrial shunt for heart failure: It's a hard no
An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.
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 ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback