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 system devices panel were unanimously opposed to recommending approval of the implant based on effectiveness and its benefit-risk profile. On the question of safety, the panelists voted 9-6 in favor of the device.
J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions.
Following the vote, a J&J spokesperson said the company is reviewing the FDA advisory panel’s recommendation for additional clinical evidence on the device.
“We will continue to work closely with the FDA, clinicians and other stakeholders to determine next steps,” the spokesperson wrote in an email.
J&J acquired the device, called the Ventura interatrial shunt, through its purchase of V-Wave in 2024. The first-of-its-kind device is a permanent implant designed to shunt blood from the left to the right atrium to reduce elevated left atrial pressure in patients with advanced chronic heart failure.
The shunt received FDA’s breakthrough device designation in 2019 for its potential to address an unmet need to improve the prognosis for patients at significant risk for hospitalization and death. The device is intended for people who have heart failure with reduced ejection fraction, when the heart muscle does not pump blood to the body with enough force.
However, in recommending against the device, panelists focused on results of the RELIEVE-HF clinical trial, which did not show improved outcomes in patients who received the shunt and failed to meet its primary endpoint.
“If you think about it from a theoretical basis, it really could be a solution. I just don’t see it in the current data,” said Paul Hauptman, dean at the University of Nevada, Reno School of Medicine.
Panelists were not swayed by subsequent analyses of the study that looked at components of the data in subgroups.
“We didn’t meet the primary endpoint, and therefore the rest is hypothesis generating,” said Richard Page, dean of the Larner College of Medicine at the University of Vermont. “We don’t want to give false hope, and we don’t want to believe that we’re addressing a problem if we really don’t have data to support that.”
While the original trial met its primary safety goal, some of the doctors also expressed concern about data signaling the potential for harm to certain patients over the longer term. Several advisers said they hoped a follow-up study of the device could eventually lead to its approval.
“I hope that will be the course. But today is not the day,” said Mitchell Krucoff, professor at Duke University School of Medicine.
