Alleviant Medical Gains FDA Breakthrough Designation for Heart Failure Technology
Alleviant Medical, Inc., a private medical device company specialising in no-implant atrial shunt technology for heart failure, has announced two significant developments from the US Food and Drug Administration (FDA).
The FDA has granted the company investigational device exemption (IDE) approval to commence a pivotal clinical trial for patients with heart failure with reduced ejection fraction (HFrEF). Additionally, the technology has been recognised with breakthrough status for this patient group.
The company’s innovative atrial shunt technology, designed to leave no permanent implant in the body, is now set to be studied across the entire spectrum of heart failure.
This includes both HFrEF and heart failure with preserved ejection fraction (HFpEF), the latter already holding FDA breakthrough designation. Globally, over 26 million people suffer from some form of heart failure.
Alleviant Medical stands as the sole organisation pursuing FDA approval for atrial shunt technology through two pivotal trials, both informed by previous sham-controlled studies. It is currently conducting the ALLAY-HF global trial for HFpEF and will soon initiate ALLAY-HFrEF.
The new ALLAY-HFrEF trial will focus on patients with reduced left ventricular ejection fraction (LVEF ≤ 40%) who continue to experience symptoms despite guideline-directed medical therapy.
It will assess the safety and efficacy of the Alleviant System, which creates an atrial shunt without leaving a permanent device in the body.
Approximately 350 patients will be enrolled in the trial, with recruitment expected to begin at select global sites in early 2025.
The design of this new trial builds upon findings from a prior study, which showed significant clinical benefits in high-risk HFrEF patients treated with a permanent atrial shunt.
The new approach aims to replicate these benefits while avoiding the need for permanent implants.
Chronic heart failure continues to be a major global health challenge, with millions of patients experiencing reduced quality of life and increased mortality.
By advancing innovative, evidence-based solutions, Alleviant Medical aims to address this pressing unmet medical need and improve outcomes for patients worldwide.
Source: https://www.businesswire.com/news/home/20250107877038/en/Novel-Heart-Failure-Technology-from-Alleviant-Medical-Gains-FDA-Approval-for-New-Pivotal-Trial-and-Breakthrough-Designation-for-Significant-Patient-Population
