Alleviant Medical has announced two milestones from the US Food and Drug Administration (FDA) relating to the development of its no-implant atrial shunt for heart failure.
FDA has granted the company investigational device exemption (IDE) approval to begin a pivotal trial focused on patients with heart failure with reduced ejection fraction (HFrEF), whilst the agency has also designated the technology with breakthrough status for this patient population.
The company’s novel atrial shunt technology, which leaves behind no permanent implant in the body, will now be investigated for patients with the full spectrum of heart failure—both reduced (HFrEF) and preserved ejection fraction (HFpEF), for which it already has FDA breakthrough designation.
Alleviant Medical is operating two pivotal trials informed by two prior sham-controlled atrial shunt trials and pursuing FDA approval across the broad spectrum of heart failure. The company has an ongoing global clinical trial in HFpEF—ALLAY-HF—and is now initiating ALLAY-HFrEF.
ALLAY-HFrEF will be led by global principal investigators Gregg Stone (Icahn School of Medicine at Mount Sinai, New York, USA) and James Udelson (Tufts University School of Medicine, Boston, USA).
“We are fortunate to have the results from a prior study that demonstrated substantial clinical benefits in high-risk HFrEF patients with an implanted permanent atrial shunt. These findings informed the design of the ALLAY-HFrEF trial, which is testing a novel device that creates an atrial shunt and leaves no permanent implant behind,” said Stone.
The new trial will evaluate the safety and effectiveness of the Alleviant system in heart failure patients with reduced left ventricular ejection fraction (LVEF ≤40%), who remain symptomatic despite guideline-directed medical therapy (GDMT). The trial will have an adaptive design and will begin enrolling approximately 350 randomised patients at select sites globally in early 2025.
“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 Udelson. “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.”
