FDA panel to review first heart failure device of its kind
Interatrial shunt systems to reduce pressure on the left atrium and lungs in patients with heart failure have been discussed at conferences and tested in trials for nearly a decade. Now, the first of those devices is scheduled to undergo a U.S. Food and Drug Administration (FDA) expert review in December.
On Dec. 3, cardiology experts on the FDA Circulatory System Devices Panel Advisory Committee Meeting will focus on the V-Wave Ventura Interatrial Shunt System, which gained an FDA breakthrough device designation in 2019. The FDA has said this permanent implant is the first device of its kind aimed at heart failure patients with reduced ejection fraction (HFrEF). The committee will discuss the merits of the device based on clinical data and make recommendations to the FDA on the device's premarket approval application (PMA). The FDA usually, but not always, accepts the recommendations of its medical expert committee members.
Johnson & Johnson acquired V-Wave in October 2024 for $600 million, but the final total could reach $1.7 billion if regulatory and commercial milestones are met. FDA approval of the device is a major part of that.
"It was of cardiovascular benefit in patients with reduced ejection fraction, where it was very, very positive," explained Gregg Stone, MD, professor of medicine at the Icahn School of Medicine, Mt. Sinai, who presented the findings of the V-Wave RELIEVE-HF pivotal trial at TCT 2024 and spoke to Cardiovascular Business.
Stone said HFrEF patients experienced significant cardiovascular benefits, including a 52% reduction in heart failure hospitalizations, and favorable trends in mortality. The device was also linked to a reduced need for advanced interventions such as heart transplants or left ventricular assist devices (LVAD).
However, patient selection with this device appears to be key, as those with heart failure with preserved left ventricular ejection fraction (HFpEF) actually suffered harm from the device in the trial. Stone said there was an increased rate of heart failure hospitalizations and mortality in HFpEF patients. He also raised questions about the strong placebo effect in this trial, where the quality of life part of the study found all patients felt better, even in patients whose conditions worsened and required hospitalization.
The virtual Circulatory System Devices Panel Advisory Committee meeting will be open to the public between 9 a.m. to 6 p.m. ET. Registration is not required to attend the meeting.
The FDA also established a docket for public comment, with the comment period ending Jan. 3.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]