Alleviant Medical received FDA approval to begin a pivotal trial of its no-implant atrial shunt for heart failure patients with reduced ejection fraction (HFrEF) and achieved breakthrough device designation for this patient group. This builds upon existing breakthrough status for the technology in patients with preserved ejection fraction (HFpEF), making Alleviant the only company with pivotal trials underway for both major forms of heart failure using shunt technology. The company is initiating the ALLAY-HFrEF trial following promising results from a prior study using an implanted shunt in high-risk HFrEF patients.
This development represents a significant advancement in heart failure treatment. Addressing both HFrEF and HFpEF with a single, minimally invasive technology offers a potential solution for the millions of patients worldwide suffering from this debilitating condition. The absence of a permanent implant differentiates Alleviant’s approach, potentially minimizing long-term complications and improving patient acceptance. This breakthrough status accelerates the regulatory pathway, bringing a much-needed therapy to patients faster.
The ALLAY-HFrEF trial, led by Drs. Gregg Stone and James Udelson, will evaluate the safety and effectiveness of the Alleviant System in approximately 350 patients with reduced ejection fraction (LVEF ≤ 40%) who haven’t responded to standard medical therapies. The trial adopts an adaptive design and is set to begin enrollment in early 2025.
Alleviant’s simultaneous pursuit of clinical trials for both HFrEF and HFpEF positions the company as a leader in developing minimally invasive heart failure solutions. Positive results from the ALLAY-HFrEF trial could transform the treatment landscape, offering a less invasive and potentially more effective option for a broader range of heart failure patients. This could lead to improved quality of life and potentially lower healthcare costs associated with managing this chronic condition.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
