Novel Heart Failure Technology from Alleviant Medical Gains FDA Approval for New Pivotal Trial and Breakthrough Designation for Significant Patient Population

AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical, Inc., a privately held medical device company pioneering a no-implant atrial shunt for heart failure, today announced two significant milestones from the U.S. Food and Drug Administration (FDA). The FDA has granted the company investigational device exemption (IDE) approval to begin a pivotal trial focused on patients with one of the most common forms of heart failure, reduced ejection fraction (HFrEF). The agency also designated the technology with breakthrough status for this patient population.

“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.”

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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. More than 26 million patients worldwide suffer from some form of heart failure.

Alleviant Medical is the only company 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 Dr. Gregg Stone and Dr. James Udelson. Dr. Stone serves as the Director of Academic Affairs and is Professor of Medicine and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York. Dr. Udelson serves as Chief of Cardiology and as Interim Chief Physician Executive of the CardioVascular Center at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine in Boston.

“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 Dr. 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 randomized 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 Dr. 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.”

With FDA’s pivotal trial approval and breakthrough designation for HFrEF, Alleviant Medical continues its mission of advancing evidence-based, breakthrough treatments to bring relief to heart failure patients globally.

About Alleviant Medical, Inc.

Alleviant Medical, Inc. is a privately held medical device company developing minimally invasive therapies to treat heart failure, collaborating with the top leaders in cardiovascular medicine to advance patient care. The Alleviant System has been granted U.S. FDA Breakthrough Device designation for both major forms of heart failure. The company is headquartered in Austin, Texas, and is backed by leading institutional and strategic investors. For more information, visit http://AlleviantMedical.com.

Note: The Alleviant System is an Investigational Device and is limited by federal (or U.S.) law to investigational use. Exclusively for clinical investigation.