Alleviant Medical's No-Implant Atrial Shunt Receives FDA IDE and Breakthrough Designation for HFrEF
• Alleviant Medical's novel atrial shunt technology, which leaves no permanent implant, receives FDA IDE approval for a pivotal trial in HFrEF patients.
• The FDA also grants Breakthrough Device designation to Alleviant's technology for HFrEF, expediting its development and review process.
• The ALLAY-HFrEF trial will evaluate the safety and effectiveness of the Alleviant System in heart failure patients with reduced ejection fraction.
• Alleviant Medical secures $90 million in financing to expand its focus to the full spectrum of chronic heart failure.
Alleviant Medical Secures $75M to Advance No-Implant Heart Failure Treatment
• Alleviant Medical closed a $75 million equity financing to fund the ALLAY-HF pivotal trial for its no-implant interatrial shunt system.
• The ALLAY-HF trial is a global, randomized, sham-controlled, double-blinded study evaluating the Alleviant System in heart failure patients.
• The Alleviant System aims to treat heart failure by creating a durable passage between the heart's atria to reduce left atrial pressure.
• Previous studies have demonstrated significant clinical improvements in heart failure patients treated with the Alleviant System.
Alleviant Medical's Transcatheter Technology Receives FDA Breakthrough Device Designation for Heart Failure
• Alleviant Medical's transcatheter technology, a no-implant interatrial shunt, has received FDA Breakthrough Device designation for treating heart failure (HFpEF/HFmrEF).
• The technology aims to alleviate elevated left atrial pressure in HFpEF/HFmrEF patients without requiring a permanent cardiac implant.
• The FDA program expedites the development and review of innovative medical devices, potentially offering quicker access to new treatments for patients.
• Clinical evidence for the Alleviant Medical technology is under development, with initial patient series outcomes expected later this year.
© Copyright 2025. All Rights Reserved by MedPath