FDA Panel Votes Against J&J V-Wave Heart Shunt Approval

Advisers to the FDA unanimously voted 15-0 against approving Johnson & Johnson’s V-Wave implantable shunt for heart failure patients not responding to medications. While 9 of 15 panelists supported the device’s safety, the panel concluded its effectiveness and benefit-risk profile were insufficient for approval.

The Ventura interatrial shunt, acquired by J&J in 2024 through V-Wave, is a permanent implant designed to redirect blood from the left to right atrium, reducing elevated left atrial pressure in advanced chronic heart failure, particularly in patients with reduced ejection fraction. It received FDA breakthrough device designation in 2019.

The panel’s decision relied on the RELIEVE-HF trial, which failed to meet its primary endpoint and did not show improved clinical outcomes. Subsequent subgroup analyses did not convince panelists of meaningful benefit. J&J said it is reviewing the recommendation and will work with the FDA and stakeholders to determine next steps.

09-12-2025