Alleviant Medical has announced obtaining both FDA investigational device exemption (IDE) and breakthrough device designation for their innovative atrial shunt.
Operating out of Austin, Texas, Alleviant has pioneered a unique no-implant atrial shunt designed to manage heart failure characterized by reduced ejection fraction (HFrEF). This cutting-edge shunt does not leave any permanent implant in the patient’s body.
Thanks to the IDE, the company is authorized to start an essential trial targeting patients affected by HFrEF. With this approval, Alleviant can now explore the application of its technology across the full spectrum of heart failure, which includes both reduced and preserved ejection fraction (HFpEF) conditions — for which they’ve already attained FDA breakthrough status.
The transcatheter device offered by Alleviant utilizes a brief pulse of energy to forge a lasting connection between the heart’s left and right atriums. This technique aims to mitigate excess pressure in the left atrium using a minimally invasive method.
“Given that more than 26 million people suffer from heart failure, each subset will have unique requirements for safe and effective treatments,” remarked CEO Adam Berman. “At Alleviant, our goal is to provide a secure, efficacious no-implant treatment to as many individuals as possible. The IDE and breakthrough designation for HFrEF significantly broadens our potential impact.”
Details on the Future Alleviant Medical Trial
Based on a recent announcement, Alleviant is the sole entity conducting two crucial trials based on previous sham-controlled atrial shunt studies. They aim for FDA approval for heart failure conditions broadly. Alongside its HFpEF trial, ALLAY-HF, the organization is preparing to launch the ALLAY-HFrEF trial.
Dr. Gregg Stone from Mount Sinai, New York, alongside Dr. James Udelson from Tufts Medical Center, Boston, spearhead the Allay-HFrEF trial as global principal investigators. Dr. Stone mentioned prior studies showing the benefits of permanent implanted atrial shunts shaped the design of ALLAY-HFrEF.
This ongoing trial will assess the safety and effectiveness of Alleviant’s groundbreaking no-implant device in participants with reduced left ventricular ejection fraction (LVEF ≤ 40%). These patients remain symptomatic despite receiving guideline-directed medical therapy (GDMT). This trial follows an adaptive approach and anticipates enrolling 350 randomized subjects at select global sites starting in early 2025.
“Despite advancements in treatment solutions, chronic heart failure still represents a major unmet clinical necessity for millions of affected individuals who endure substantial hardship and often experience a shortened lifespan due to the disease,” remarked Udelson. “By advancing scientific understanding and expanding the evidence base for various ejection fractions, there’s potential to enhance clinical outcomes and improve quality of life for countless individuals.”