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# FDA Advisers Reject J&J’s V-Wave Heart Shunt
- URL: https://www.fdaweb.com/fda-advisers-reject-j-js-v-wave-heart-shunt/
- Published: 2025-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:28:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160338

An FDA advisory committee has voted unanimously against recommending approval of Johnson & Johnson’s V-Wave heart shunt for patients with advanced heart failure who have not responded to medication, citing insufficient evidence that the implant works.

The FDA’s circulatory system devices advisory panel voted **15-0** that the device failed to demonstrate effectiveness and that its overall benefit-risk profile did not support approval. On the question of safety, however, the panel was more divided, voting **9-6** that the device appeared adequately safe based on available data.

The implant is designed to help relieve pressure in the left atrium and improve symptoms in patients with refractory heart failure. While FDA advisory committees provide guidance, the agency is not required to follow their recommendations.

In a statement following the vote, a Johnson & Johnson spokesperson said the company is evaluating the panel’s feedback, particularly the call for additional clinical evidence.