Austin, Texas-based Alleviant develops a no-implant atrial shunt for treating heart failure. That includes reduced ejection fraction (HFrEF), a common form of heart failure. Its novel shunt leaves behind no permanent implant in the body.
The IDE allows the company to begin a pivotal trial focused on patients with HFrEF. Alleviant can now investigate its technology for patients with the full spectrum of heart failure. That includes both reduced and preserved ejection fraction (HFpEF), for which it already holds FDA breakthrough designation.
Alleviant’s transcatheter device uses a short pulse of energy to create a durable passage between the heart’s left and right atrium. It aims to reduce excess pressure within the left atrium through a less-invasive approach.
“With more than 26 million patients suffering from heart failure, every subset of those patients will have distinct needs for safe and effective therapies,” said CEO Adam Berman. “Our mission at Alleviant is to bring a safe, effective no-implant treatment option to as many of those patients as we can, and the IDE and breakthrough designation for HFrEF dramatically expands our potential reach.”
More about the upcoming Alleviant Medical trial
According to a news release, Alleviant is now the only company running two pivotal trials informed by two prior sham-controlled atrial shunt trials and pursuing FDA approval across the broad spectrum of heart failure. In addition to its HFpEF trial, ALLAY-HF, it intends to initiate the ALLAY-HFrEF trial.
Dr. Gregg Stone of Mount Sinai (New York) and Dr. James Udelson of Tufts Medical Center (Boston) lead Allay-HFrEF as global principal investigators. Stone said the findings from a prior study demonstrating the benefits of a permanent implanted atrial shunt informed the design of ALLAY-HFrEF.
This trial, though, evaluates the safety and effectiveness of Alleviant’s novel no-implant device. It looks at patients with reduced left ventricular ejection fraction (LVEF≤40%). Those subjects remain symptomatic despite guideline-directed medical therapy (GDMT). The trial features an adaptive design. Alleviant expects to begin enrolling 350 randomized patients across select global sites 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.”
