Alleviant Medical Secures FDA Approval for Pivotal Heart Trial

Alleviant Medical's Latest FDA Approval for Heart Failure Treatment

Alleviant Medical, Inc., a pioneering medical device company focused on developing innovative solutions for heart failure, has announced key progress with the U.S. Food and Drug Administration (FDA). The agency has granted the company investigational device exemption (IDE) approval to initiate a pivotal clinical trial targeting a prevalent type of heart failure known as reduced ejection fraction (HFrEF). Alongside this approval, the FDA has also awarded a breakthrough designation to Alleviant's unique no-implant atrial shunt technology.

A Novel Approach to Heart Failure

This groundbreaking technology is notable for not leaving any permanent implant in the patients' bodies. Its potential effects will now be investigated across the entire spectrum of heart failure, including both HFrEF and preserved ejection fraction (HFpEF). With over 26 million individuals affected by heart failure globally, the significance of this research cannot be understated.

Two Pivotal Trials in Progress

Alleviant Medical stands out as the sole company running two pivotal trials based on valuable insights from previous controlled research studies on atrial shunts. Those trials have bolstered the company’s efforts toward achieving FDA approval catering to the broad heart failure patient demographic. This commitment is exemplified by the ongoing global clinical trial, referred to as ALLAY-HF, which focuses on HFpEF, as well as the newly initiated ALLAY-HFrEF trial.

Leadership in Clinical Research

The ALLAY-HFrEF trial will be spearheaded by distinguished principal investigators, Dr. Gregg Stone and Dr. James Udelson. Dr. Stone, an authority in cardiovascular medicine, holds prominent positions at the Icahn School of Medicine at Mount Sinai. Meanwhile, Dr. Udelson leads the Cardiovascular Center at Tufts Medical Center and is a respected professor at Tufts University School of Medicine.

Transformative Study Ahead

Dr. Stone expressed enthusiasm for the progress made so far, noting the benefits seen in high-risk HFrEF patients through previous studies using an implanted atrial shunt. This groundwork has significantly influenced the design of the ALLAY-HFrEF trial, which aims to utilize a revolutionary device creating an atrial shunt without any device retention.

Trial Design and Goals

This new clinical study will evaluate the safety and effectiveness of the Alleviant System in patients with reduced left ventricular ejection fraction (LVEF ? 40%). Targeting those who remain symptomatic despite current guidelines for medical therapy, the trial will have an adaptive design and aims to enroll around 350 randomized participants across selected globally sites starting early in 2025.

The Broader Implications of Research

Dr. Udelson highlighted the pressing need for innovative treatments as chronic heart failure continues to pose substantial challenges for millions. As the study embraces scientific advancements, the potential exists not only for improving clinical outcomes but also enhancing the quality of life for numerous individuals suffering from this condition.

With the FDA's pivotal trial approval and breakthrough designation for HFrEF, Alleviant Medical reaffirms its commitment to advancing evidence-based solutions aimed at bringing relief to heart failure patients worldwide.

About Alleviant Medical, Inc.

Alleviant Medical, Inc. is a privately held entity dedicated to creating minimally invasive therapies for heart failure. The company partners with top leaders in cardiovascular medicine to enhance patient care significantly. The Alleviant System has received the U.S. FDA Breakthrough Device designation addressing both primary forms of heart failure. Based in Austin, Texas, Alleviant Medical is supported by prominent institutional and strategic investors.

Frequently Asked Questions

What is the focus of Alleviant Medical's trials?

Alleviant Medical's trials focus on evaluating the safety and efficacy of their no-implant atrial shunt technology for treating heart failure.

What types of heart failure does the new trial address?

The trial addresses both reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) heart failure types.

What is the expected enrollment for the new trial?

The ALLAY-HFrEF trial aims to enroll approximately 350 randomized patients across select global sites.

Who are the leading investigators for the ALLAY-HFrEF trial?

Dr. Gregg Stone and Dr. James Udelson will lead the ALLAY-HFrEF trial.

What distinguishes Alleviant Medical's approach to heart failure?

Alleviant's approach is unique as it develops a no-implant atrial shunt technology aimed at offering innovative treatment options for heart failure patients without leaving permanent devices in their bodies.

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