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 ...
FDA panel rejects J&J heart device citing lack of efficacy and unresolved safety issues, delaying market entry for the ...
Panelists considered the technology relatively safe but weren’t swayed by the “statistical gymnastics” needed to find a ...
J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the ...
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 ...
Brian Fahey explains how Adona Medical uses heat to adjust its novel shape memory nitinol implant without harming heart ...
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.
Researcher Stephanie TerMaath has always had a head for physics. As the University of Tennessee's Zeanah Faculty Fellow, she's involved in projects including developing composite patches for repairing ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback