The US Food and Drug Administration (FDA) has granted Alleviant Medical an investigational device exemption (IDE), enabling the company to begin a pivotal trial evaluating its atrial shunt transcatheter technology.
Alleviant has developed a device that leaves behind no permanent implant and is aimed at chronic, symptomatic heart failure patients despite appropriate medical therapy.
The device is inserted into a groin blood vessel and advanced into the heart. The approach works by creating a connection between the left and right atrial chambers using a short pulse of energy to cut tissue, reducing pressure buildup within the left atrium.
The pivotal trial will evaluate the technology in patients with reduced ejection fraction (HFrEF), a form of heart failure that accounts for around 60% of people with the disease. Around 350 patients with reduced left ventricular ejection fraction who remain symptomatic despite guideline-directed medical therapy (GDMT) will be enrolled. Enrolment in the trial, which will be called ALLAY-HFrEF, is slated to begin in early 2025, according to Alleviant.
Along with the IDE, the FDA also granted breakthrough status to Alleviant for the system’s use in treating HFrEF. Breakthrough status is designed to expedite the route to market. Manufacturers who gain this designation are eligible for enhanced interaction with FDA experts and prioritised review when the time comes for regulatory submission. The Alleviant system has already had breakthrough status for preserved ejection fraction (HFpEF) since 2021.
Alleviant is already conducting the ALLAY-HF study (NCT05685303), a randomised and sham-controlled trial evaluating the system in patients with HFpEF.
Icahn School of Medicine’s Dr Gregg Stone, who will serve as principal investigator of the trial, said: “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.”
The cardiovascular device market was estimated to be worth $72.2bn in 2024, with it forecast to grow to $116.8bn by 2033, as per analysis by GlobalData.
Also in the atrial shunt space is V-Wave, which conducted a randomised trial last year but its Ventura shunt failed to meet the primary endpoint. However, Johnson & Johnson saw the potential in the platform and acquired the company for an upfront payment of $600m in August. Corvia Medical, meanwhile, reported positive three-year results in October 2024 from a Phase III trial evaluating its shunt technology.
