No-Implant Shunt Wins FDA Breakthrough Status for HF

Texas-based medical device company Alleviant has received a breakthrough device status from the US Food and Drug Administration (FDA) for its new no-implant atrial shunt for heart failure and will begin a clinical trial of the device.

More than 26 million people from around the world have some form of heart failure, and the new trial will focus on patients with reduced ejection fraction: one of the most common forms of heart failure.

The company says its device is designed to create a connection between the left and right atrial chambers of the heart through a single procedure without leaving a permanent implant behind. Alleviant already has an ongoing trial, ALLAY-HF, of the device in people with heart failure with preserved ejection fraction.

ALLAY-HFrEF Trial

The new trial known as ALLAY-HFrEF will begin enrolling approximately 350 patients around the world in early 2025. It will evaluate the safety and effectiveness of the Alleviant device in patients with heart failure and reduced left ventricular ejection fraction (LVEF ≤ 40%) who remain symptomatic despite guideline-directed medical therapy.

“Despite progress in treatment options, chronic heart failure remains one of the greatest unmet clinical needs for millions of patients who suffer deeply and whose lives are often cut short by the condition,” said James Udelson, MD, chief of cardiology at Tufts Medical Center, Boston, one of the co-leaders of the new trial. “As we follow the science and expand the evidence base for patients with different ejection fractions, we have the potential to improve clinical outcomes as well as quality of life for millions.”

The FDA’s breakthrough device designation is intended to speed up the development, assessment, and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

“We are fortunate to have the results from a prior study that demonstrated substantial clinical benefits in high-risk patients with HFrEF and an implanted permanent atrial shunt,” said Gregg Stone, MD, director of academic affairs and professor of medicine and population health sciences and policy at the Icahn School of Medicine at Mount Sinai, New York. “These findings informed the design of the ALLAY-HFrEF trial.” 

The FDA’s staff will work directly with the manufacturer, and any submissions related to the device will be prioritized.

Drs. James Udelson and Gregg Stone are lead investigators of the ALLAY-HFrEF Trial supported by Alleviant Medical Inc.