Two years of echocardiographic data affirm positive effects of atrial shunt therapy on heart structure and function

两年的超声心动图数据证实了心房分流治疗对心脏结构和功能的积极影响

TEWKSBURY, Mass., May 7, 2024 /PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the publication in JAMA Cardiology of two-year echocardiographic data from its REDUCE LAP-HF II randomized clinical trial of the Corvia® Atrial Shunt, offering groundbreaking insight into the impact of a shunt on the heart..

马萨诸塞州特克斯伯里，2024年5月7日/PRNewswire/--Corvia Medical，Inc，一家致力于改变心力衰竭治疗的公司，今天宣布在JAMA Cardiology上发布了来自其REDUCE LAP-HF II Corvia®心房分流术随机临床试验的两年超声心动图数据，为分流对心脏的影响提供了开创性的见解。。

The study demonstrated favorable long-term effects of atrial shunting on heart structure and function in patients with heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF). Analysis showed that atrial shunting led to favorable cardiac remodeling, restoration of the heart's normal function, with resulting improvements in clinical outcome and prognosis..

该研究表明，心房分流对射血分数保留或轻度降低的心力衰竭患者的心脏结构和功能具有良好的长期影响。分析表明，心房分流术导致了良好的心脏重塑，恢复了心脏的正常功能，从而改善了临床结果和预后。。

The analysis also demonstrated more favorable remodeling in previously defined responders compared to non-responders, confirming that patients with no latent pulmonary vascular disease and no cardiac pacemaker are most likely to benefit from atrial shunt therapy.

该分析还表明，与无反应者相比，先前定义的反应者的重塑更有利，证实没有潜伏性肺血管疾病和无心脏起搏器的患者最有可能从心房分流治疗中受益。

'We now have two-year evidence of reverse remodeling in patients with an atrial shunt, with more pronounced improvements in cardiac structure and function — and associated clinical benefit — in previously defined responders versus non-responders,' said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University School of Medicine and lead investigator for the study.

西北大学医学院HFpEF项目主任兼该研究的首席研究员桑吉夫·沙阿（Sanjiv Shah）医学博士说：“我们现在有两年的证据表明，心房分流患者的逆向重塑，在先前确定的应答者和无应答者中，心脏结构和功能以及相关的临床益处得到了更明显的改善。”。

'This data not only offers insight into the long-term effects of atrial shunting but also represents the largest and most comprehensive echocardiographic follow-up study of any device or pharmacological trial in HFpEF and HFmrEF to date..

“这些数据不仅提供了对心房分流的长期影响的深入了解，而且代表了迄今为止HFpEF和HFmrEF中任何设备或药理学试验的最大和最全面的超声心动图随访研究。”。。

'The findings of our study support the referral of suitable patients to RESPONDER-HF, a randomized, sham-controlled trial now underway in the US, Europe and Australia in pursuit of the evidence required to achieve FDA approval of the Corvia Atrial Shunt for millions of heart failure patients.'

“我们的研究结果支持将合适的患者转介给RESPONDER-HF，这是一项随机，假对照试验，目前正在美国，欧洲和澳大利亚进行，以寻求获得FDA批准数百万心力衰竭患者Corvia心房分流术所需的证据。”

About heart failure (HF) and the Corvia Atrial Shunt

关于心力衰竭（HF）和冠状动脉-心房分流术

More than 26 million people worldwide have HF, and the majority have HFpEF, making it the largest unmet clinical need in cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated left atrial pressure (LAP), the primary contributor to HF symptoms in HFpEF patients, by creating a passage between the left and right atria, reducing HF events and improving quality of life.

全世界有2600多万人患有HF，其中大多数患有HFpEF，使其成为心血管医学中最大的未满足临床需求。Corvia心房分流术旨在通过在左右心房之间建立通道，减少HF事件并改善生活质量，从而降低HFpEF患者HF症状的主要原因左心房压力升高（LAP）。

The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. For information regarding RESPONDER-HF study eligibility, please visit https://treatmyheartfailure.com..

2019年，Corvia心房分流术被FDA授予突破性设备称号。有关RESPONDER-HF研究资格的信息，请访问https://treatmyheartfailure.com..

About Corvia Medical, Inc.

关于Corvia Medical，Inc。

Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, privately-held Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives.

Corvia Medical，Inc.正在通过新型经导管心血管设备彻底改变心力衰竭的治疗方法。成立于2009年，总部位于马萨诸塞州特克斯伯里的私营公司Corvia致力于改变心力衰竭治疗的护理标准，使患者能够恢复生命。

Visit https://corviamedical.com..

参观https://corviamedical.com..

MEDIA CONTACT:

媒体联系人：

Lisa Ensz

Lisa Ensz

+1 978-654-6120

+1 978-654-6120

lensz@corviamedical.com

lensz@corviamedical.com

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SOURCE Corvia Medical, Inc.

SOURCE Corvia Medical公司。