FDA Approves New Trial for Alleviant Medical’s Heart Failure Tech

Alleviant Medical Inc. has earned U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval to begin a pivotal trial focused on patients with reduced ejection fraction (HFrEF). The agency also granted the technology breakthrough status for this patient population.

The company’s 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), the latter of which already has FDA breakthrough designation. More than 26 million patients worldwide suffer from some form of heart failure; HFrEF is one of the most common.

Alleviant Medical claims to be the only company operating two pivotal trials informed by two prior sham-controlled atrial shunt studies and pursuing FDA approval across heart failure’s broad spectrum. 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 Drs. Gregg Stone and James Udelson. Dr. Stone is the director of Academic Affairs, professor of Medicine and professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, N.Y. Dr. Udelson is chief of Cardiology, 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,” Dr. Stone said.

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 enroll approximately 350 randomized patients at select sites globally.

“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,” Dr. Udelson stated. “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.”

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 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. The Alleviant System is an investigational device and limited by federal (or U.S.) law to investigational use.