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

Johnson & Johnson’s billion-dollar bet on a novel implant for heart failure hit a roadblock this week, with an FDA advisory panel unanimously voting against its risk-benefit profile. The V-Wave ...

Advisers to the Food and Drug Administration on Wednesday voted 15-0 against use of Johnson & Johnson’s V-Wave shunt for heart failure patients not helped by medications. Members of the circulatory ...

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 ...

Congenital heart defects (CHDs) are among the top eight causes of infant mortality worldwide. Annually, CHDs affect around 40,000 infants in the United States, with approximately one in four having a ...

The atria play an important role in the pathophysiology of heart failure with preserved ejection fraction. Decreased left atrial strain is associated with worse clinical outcomes. The impact of ...

10 patients enrolled with 100% implantation success Adona's adjustable interatrial shunt is designed so it can be modified post-implantation to provide a more adaptive and personalized lifetime ...

Within the prior 24 months, I have had a financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: Receive the the ...