An FDA panel unanimously rejected J&J's V-Wave Ventura heart shunt, citing risks outweighing benefits despite safety data.

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 ...

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 ...

An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.

Ventura's permanent interatrial shunt was designed to shunt blood from the left to right atrium to improve symptoms in ...

Avisi Technologies, Inc., an ophthalmic medical device company advancing novel, sight-saving technologies, announces the first patient in the international SAPPHIRE Trial has been treated with Avisi's ...

When we first interviewed Adona Medical co-founder and CEO Brian Fahey in 2023, the Shifamed startup’s use of shape memory nitinol had obvious potential, even if he wouldn’t explain exactly how the ...

Researchers have found in largest prospective dataset on tube shunt outcomes that Chronic hypotony is a rare complication of tube shunt surgery that often leads to reduced visual acuity and the key ...