Alleviant Medical, Inc., a privately held medical device company pioneering a no-implant atrial shunt for heart failure, today announced two significant milestones from the U.S. Food and Drug Administration (FDA). The FDA has granted the company investigational device exemption (IDE) approval to begin a pivotal trial focused on patients with one of the most common forms of heart failure, reduced ejection fraction (HFrEF).

Alleviant Medical, Inc.一家私营医疗器械公司今天宣布了美国食品和药物管理局（FDA）的两个重要里程碑，该公司开创了无植入物心房分流术治疗心力衰竭的先河。美国食品和药物管理局（FDA）已批准该公司的研究设备豁免（IDE），以开始一项关键试验，该试验的重点是患有最常见的心力衰竭之一，射血分数降低（HFrEF）的患者。

The agency also designated the technology with breakthrough status for this patient population..

该机构还为该患者群体指定了具有突破性地位的技术。。

The company’s novel atrial shunt technology, which leaves behind no permanent implant in the body, will now be investigated for patients with the full spectrum of heart failure - both reduced (HFrEF) and preserved ejection fraction (HFpEF), for which it already has FDA breakthrough designation. More than 26 million patients worldwide suffer from some form of heart failure..

该公司的新型心房分流术技术在体内没有留下永久性植入物，现在将针对患有全谱心力衰竭的患者进行研究-包括减少（HFrEF）和保留射血分数（HFpEF），该技术已经获得FDA突破性指定。全世界有2600多万患者患有某种形式的心力衰竭。。

Alleviant Medical is the only company operating two pivotal trials informed by two prior sham-controlled atrial shunt trials and pursuing FDA approval across the broad spectrum of heart failure. The company has an ongoing global clinical trial in HFpEF,

Alleviant Medical是唯一一家运营两项关键试验的公司，这两项关键试验是由之前的两项假控制心房分流试验通知的，并在广泛的心力衰竭中寻求FDA批准。该公司正在进行HFpEF的全球临床试验，

ALLAY-HF

ALLAY-HF公司

, and is now initiating ALLAY-HFrEF.

，现在正在启动ALLAY HFrEF。

ALLAY-HFrEF will be led by global principal investigators Dr. Gregg Stone and Dr. James Udelson. Dr. Stone serves as the Director of Academic Affairs and is Professor of Medicine and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York. Dr. Udelson serves as Chief of Cardiology and as Interim Chief Physician Executive of the CardioVascular Center at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine in Boston..

ALLAY HFrEF将由全球首席研究员Gregg Stone博士和James Udelson博士领导。斯通博士担任纽约西奈山伊坎医学院学术事务主任、医学教授、人口健康科学与政策教授。乌德尔森博士担任塔夫茨医学中心心血管中心主任兼临时首席医师兼波士顿塔夫茨大学医学院医学与放射学教授。。

“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. These findings informed the design of the ALLAY-HFrEF trial, which is testing a novel device that creates an atrial shunt and leaves no permanent implant behind,” said Dr.

“我们很幸运，之前的一项研究结果显示，植入永久性心房分流术的高危HFrEF患者具有实质性的临床益处。这些发现为ALLAY HFrEF试验的设计提供了依据，该试验正在测试一种新型装置，该装置可产生心房分流，并且不会留下永久性植入物，”Dr。

Stone..

石头。。

The new trial will evaluate the safety and effectiveness of the Alleviant System in heart failure patients with reduced left ventricular ejection fraction (LVEF≤40%), who remain symptomatic despite guideline-directed medical therapy (GDMT). The trial will have an adaptive design and will begin enrolling approximately 350 randomized patients at select sites globally in early 2025.

这项新的试验将评估Alleviant系统在左心室射血分数（LVEF）降低的心力衰竭患者中的安全性和有效性≤40%），尽管有指南指导的药物治疗（GDMT），但仍有症状。该试验将采用适应性设计，并将于2025年初开始在全球选定地点招募约350名随机患者。

“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,” said Dr. Udelson. “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.”.

Udelson博士说：“尽管在治疗方案方面取得了进展，但慢性心力衰竭仍然是数百万患者最大的未满足临床需求之一，这些患者深受痛苦，他们的生命经常因此而缩短。”。“随着我们遵循科学并扩大不同射血分数患者的证据基础，我们有可能改善数百万人的临床结果和生活质量。”。

With FDA’s pivotal trial approval and breakthrough designation for HFrEF, Alleviant Medical continues its mission of advancing evidence-based, breakthrough treatments to bring relief to heart failure patients globally.

随着FDA对HFrEF的关键试验批准和突破性指定，Alleviant Medical继续其推进循证突破性治疗的使命，为全球心力衰竭患者带来缓解。

About Alleviant Medical, Inc.

关于Alleviant Medical，Inc。

Alleviant Medical, Inc. is a privately held medical device company developing minimally invasive therapies to treat heart failure, collaborating with the top leaders in cardiovascular medicine to advance patient care. The Alleviant System has been granted U.S. FDA Breakthrough Device designation for both major forms of heart failure.

Alleviant Medical，Inc.是一家私营医疗器械公司，开发治疗心力衰竭的微创疗法，与心血管医学领域的顶级领导者合作，推进患者护理。Alleviant系统已被美国FDA授予两种主要形式心力衰竭的突破性设备名称。