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
歐洲的商業驗證與正在進行的RESPONDER-HF臨牀試驗並行進行
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.
馬薩諸塞州特威克斯伯裏，2024年12月20日 /PRNewswire/ -- Corvia Medical, Inc.是一家致力於改變心衰治療的公司，今天宣佈其Corvia房間分流系統已獲得最新的歐洲醫療器械法規（EU MDR 2017/745）下的CE認證。Corvia房間分流是一種基於導管的心臟植入裝置，旨在通過降低心臟和肺部的壓力來減輕心衰症狀。
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）影響全球超過2600萬人，其中超過一半的人經歷射血分數保留的心衰（HFpEF），這種狀態下患者在休息時感到舒適，但在任何活動中都會立即感到呼吸困難。治療選擇有限。
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房間分流旨在通過在左心房和右心房之間創建受控通道來減輕左心房壓力（LAP）的升高——這是HF症狀的主要驅動因素。目前全球大約70個研究中心參與RESPONDER-HF，這是一項確認性的隨機臨牀試驗，招募沒有潛在肺血管疾病或起搏器的HF患者，之前的Corvia試驗表明這些患者從分流中獲得了顯著的臨牀益處。
"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."
「在醫療器械的嚴格要求下獲得MDR的CE標誌，對於Corvia Medical來說是一個重要的里程碑，」Corvia Medical的質量與法規事務副總裁Kate Stohlman表示。「這一批准反映了我們全球團隊在設備安全性和臨牀性能的最高水平上的奉獻、承諾和努力，並持續滿足監管機構的要求。」
About Corvia Medical, Inc.
關於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.通過新型導管心血管設備正在革命性地改變心衰的治療。公司成立於2009年，總部位於馬薩諸塞州特威克斯伯裏，Corvia致力於改變心衰治療的護理標準，使患者能夠重新獲得生活。Corvia房間分流在2019年獲得FDA的突破性設備認定。作爲私人公司，Corvia得到了Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, 愛德華生命科學及一位未公開的戰略投資者的支持。有關更多信息，請訪問us.corviamedical.com。可以在這裏找到RESPONDER-HF試驗的醫生推薦/註冊信息
MEDIA CONTACT:
Lisa Ensz
+1 978-654-6120
[email protected]
媒體聯繫方式：
麗莎·恩茨
+1 978-654-6120
[email protected]
SOURCE Corvia Medical, Inc.
來源：科維亞醫療公司
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