Corvia Medical Achieves CE Certification for Atrial Shunt Under New EU MDR Standards
Corvia Medical Achieves CE Certification for Atrial Shunt Under New EU MDR Standards
The Corvia Atrial Shunt is designed to alleviate elevated left atrial pressure (LAP) — a primary driver of HF symptoms — by creating a controlled passage between the left and right atria. Some 70 study sites worldwide are currently participating in RESPONDER-HF, a confirmatory, randomized clinical trial enrolling HF patients without latent pulmonary vascular disease or pacemakers, who have been shown in previous Corvia trials to experience substantial clinical benefit from shunting.Commercial validation in Europe parallels ongoing RESPONDER-HF clinical trial
欧洲的商业验证与正在进行的RESPONDER-HF临床试验并行进行
TEWKSBURY, Mass., Dec. 20, 2024 /PRNewswire/ -- Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, announced today that it has achieved CE certification for the Corvia Atrial Shunt System under the latest EU Medical Device Regulations (EU MDR 2017/745). The Corvia Atrial Shunt is a catheter-based cardiac implant designed to reduce heart failure symptoms by lowering pressures in the heart and lungs.
马萨诸塞州特威克斯伯里，2024年12月20日 /PRNewswire/ -- Corvia Medical, Inc.是一家致力于改变心衰治疗的公司，今天宣布其Corvia房间分流系统已获得最新的欧洲医疗器械法规（EU MDR 2017/745）下的CE认证。Corvia房间分流是一种基于导管的心脏植入装置，旨在通过降低心脏和肺部的压力来减轻心衰症状。
Heart failure (HF) affects over 26 million people worldwide, with more than half experiencing heart failure with preserved ejection fraction (HFpEF), a condition in which patients are comfortable at rest but become immediately breathless with any exertion. Treatment options are limited.
心衰（HF）影响全球超过2600万人，其中超过一半的人经历射血分数保留的心衰（HFpEF），这种状态下患者在休息时感到舒适，但在任何活动中都会立即感到呼吸困难。治疗选择有限。
The Corvia Atrial Shunt is designed to alleviate elevated left atrial pressure (LAP) — a primary driver of HF symptoms — by creating a controlled passage between the left and right atria. Some 70 study sites worldwide are currently participating in RESPONDER-HF, a confirmatory, randomized clinical trial enrolling HF patients without latent pulmonary vascular disease or pacemakers, who have been shown in previous Corvia trials to experience substantial clinical benefit from shunting.
Corvia房间分流旨在通过在左心房和右心房之间创建受控通道来减轻左心房压力（LAP）的升高——这是HF症状的主要驱动因素。目前全球大约70个研究中心参与RESPONDER-HF，这是一项确认性的随机临床试验，招募没有潜在肺血管疾病或起搏器的HF患者，之前的Corvia试验表明这些患者从分流中获得了显著的临床益处。
"The CE Mark under the MDR for an implantable therapeutic cardiac device with the strictest requirements is a significant milestone for Corvia Medical" said Kate Stohlman, VP of Quality and Regulatory Affairs at Corvia Medical. "This approval reflects the dedication, commitment and efforts of our entire global team to the highest levels of device safety and clinical performance, and to continuously meet the requirements of the regulatory authorities."
“在医疗器械的严格要求下获得MDR的CE标志，对于Corvia Medical来说是一个重要的里程碑，”Corvia Medical的质量与法规事务副总裁Kate Stohlman表示。“这一批准反映了我们全球团队在设备安全性和临床性能的最高水平上的奉献、承诺和努力，并持续满足监管机构的要求。”
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, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. For more information visit visit us.corviamedical.com. Physician referral/enrollment information for the RESPONDER-HF trial can be found at
Corvia Medical, Inc.通过新型导管心血管设备正在革命性地改变心衰的治疗。公司成立于2009年，总部位于马萨诸塞州特威克斯伯里，Corvia致力于改变心衰治疗的护理标准，使患者能够重新获得生活。Corvia房间分流在2019年获得FDA的突破性设备认定。作为私人公司，Corvia得到了Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, 爱德华生命科学及一位未公开的战略投资者的支持。有关更多信息，请访问us.corviamedical.com。可以在这里找到RESPONDER-HF试验的医生推荐/注册信息
MEDIA CONTACT:
Lisa Ensz
+1 978-654-6120
[email protected]
媒体联系方式：
丽莎·恩茨
+1 978-654-6120
[email protected]
SOURCE Corvia Medical, Inc.
来源：科维亚医疗公司