FDA Panel Unanimously Rejects J&J's Novel Heart Failure Device

Johnson & Johnson's ambitious foray into the heart failure device market hit a significant roadblock as an FDA advisory panel unanimously voted against recommending approval for the company's V-Wave Ventura interatrial shunt. The panel's decision, based on concerns over the device's effectiveness and risk-benefit profile, casts doubt on the future of this innovative technology and J&J's billion-dollar investment.

Clinical Trial Results Fall Short of Expectations

The FDA's circulatory system devices panel focused their evaluation on the results of the RELIEVE-HF clinical trial, which failed to meet its primary endpoint. The study, involving 508 patients, showed no significant differences in outcomes between the shunt and control groups after two years. This included a composite measurement of deaths, worsening cases of heart failure, hospitalizations, and changes in symptom questionnaires.

Dr. Paul Hauptman, dean at the University of Nevada, Reno School of Medicine, summarized the panel's sentiment: "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."

Safety Concerns and Subgroup Analyses

While the trial met its primary safety goal, some panelists expressed concern about data signaling potential harm to certain patients over the longer term. Notably, patients with heart failure with preserved ejection fraction (HFpEF) who received the shunt performed worse compared to the control group, while those with reduced ejection fraction (HFrEF) showed some improvements.

The panel was not swayed by subsequent analyses of study data in subgroups. Dr. Richard Page, dean of the Larner College of Medicine at the University of Vermont, cautioned against over-interpreting these results: "We didn't meet the primary endpoint, and therefore the rest is hypothesis generating. 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."

Future Prospects and Industry Impact

Despite the setback, several advisers expressed hope that follow-up studies could eventually lead to the device's approval. Dr. Mitchell Krucoff, professor at Duke University School of Medicine, echoed this sentiment: "I hope that will be the course. But today is not the day."

The panel's decision raises questions about J&J's $1.7 billion acquisition of V-Wave in 2024, which included $600 million offered upfront. The company now faces the challenge of determining next steps for the device, which had previously received FDA's breakthrough device designation in 2019.

A J&J spokesperson stated that the company is reviewing the FDA advisory panel's recommendation and will "continue to work closely with the FDA, clinicians and other stakeholders to determine next steps."