According to a report in CardiovascularBusiness, the 15-person Circulatory System Devices Panel found that data on Ventura failed to demonstrate the benefits necessary to receive its backing when compared to the risk.
Placed in the heart through a minimally invasive, catheter-based procedure, Ventura could fill a treatment gap between guideline-directed medical therapies as a first-line therapy and highly invasive cardiac replacement therapies, including left ventricular assist devices (LVADs) and heart transplants.
The implant specifically targets heart failure with reduced ejection fraction (HFrEF). Ventura first received FDA breakthrough device designation in 2019 and picked up CE mark in 2020. Johnson & Johnson acquired V-Wave, the maker of Ventura, last year.
According to the report, the panel reviewed data from the company’s RELIEVE-HF trial of 206 people with HFrEF and 302 patients with heart failure with preserved ejection fraction (HFpEF). The trial met its primary safety endpoint, with no major adverse cardiovascular or neurological events at 30 days or 24 months. While HFrEF patients saw some benefits, HFpEF patients didn’t.
Dr. William Abraham, who led the trial, explained the outcomes in a recent interview with Medical Design and Outsourcing.
While the FDA takes the panel’s decisions into account when deciding on a device’s approval, the agency could still give Ventura the green light. The panel recommended additional clinical evidence on the shunt for HFrEF.
A J&J spokesperson told MassDevice today:
“We are currently reviewing the FDA advisory panel’s recommendation for additional clinical evidence on the V-Wave Ventura interatrial shunt for patients with heart failure with reduced ejection fraction. We will continue to work closely with the FDA, clinicians and other stakeholders to determine next steps.”
Ventura features a nitinol hourglass frame to decrease elevated left atrial pressure seen in congestive heart failure. It achieves this by creating a shunt between the left and right atrium. The system could reduce cardiovascular events and heart failure hospitalizations. (Read more about the technology at Medical Design & Outsourcing.)
