The outside advisors analyzed the results of the RELIEVE-HF pivotal trial, which randomized 508 patients to either receive ...

Brian Fahey explains how Adona Medical uses heat to adjust its novel shape memory nitinol implant without harming heart ...

J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the ...

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

Panelists considered the technology relatively safe but weren’t swayed by the “statistical gymnastics” needed to find a ...

OBJECT: Post-traumatic hydrocephalus (PTH) is considered a frequent complication after severe head injury (HI). There is little known about outcome following shunt implantation. METHODS: A ...

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

Please provide your email address to receive an email when new articles are posted on . Interatrial shunt implant lowered HF hospitalization risk for patients with HFrEF vs. placebo. However, patients ...

Children born with certain heart defects undergo a series of invasive surgeries early in life. The first surgery includes implantation of a shunt to improve blood flow. However, as children grow, the ...

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

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 ...