FDA sees value in no-implant heart failure device
Alleviant Medical, a Texas-based medical device company, has received the FDA’s breakthrough device designation and an investigational device exemption (IDE) for its new atrial shunt that treats heart failure without leaving a permanent implant in the body.
The FDA’s breakthrough devices program is designed to help expedite medical devices through the approval process. The agency’s representatives work directly with the manufacturer, and any submissions related to the device will be prioritized. This designation is reserved for devices that, according to the FDA, “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
The IDE, meanwhile, paves the way for Alleviant to launch ALLAY-HFrEF, a new global clinical trial designed to evaluate the device’s safety and effectiveness in approximately 350 patients with heart failure with reduced ejection fraction (HFrEF). Two renowned cardiovascular researchers—Gregg Stone, MD, with the Icahn School of Medicine at Mount Sinai in New York and James Udelson, MD, with Tufts University School of Medicine in Boston—will serve as the trial’s co-principal investigators.
ALLAY-HF, a similar global trial focused on the device’s ability to treat heart failure with preserved ejection fraction (HFpEF), is already underway.
“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,” Udelson said in a statement. “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.”
“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,” added Stone. “These findings informed the design of the ALLAY-HFrEF trial.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.