CLEVELAND

克利夫兰

,

，

March 5, 2026

2026年3月5日

/PRNewswire/ --

/PRNewswire/ --

Mitria Medical, a structural heart company developing a next generation transcatheter solution for mitral valve repair,

Mitria Medical，一家开发新一代经导管二尖瓣修复解决方案的结构性心脏病公司，

announced the first implantation of its novel

宣布了其新型装置的首次植入

Subvalvular Spacer (SVS)

瓣下间隔器 (SVS)

in the United States under the U.S. Food and Drug Administration (FDA) Single Patient Expanded Access Program. Expanded Access, often called 'compassionate use', allows a patient with a serious, immediately life-threatening condition to access an investigational medical product outside of clinical trials when no satisfactory alternative options are available.

在美国，根据美国食品药品监督管理局 (FDA) 的单患者扩大使用计划，扩大使用（通常称为“同情使用”）允许患有严重、立即危及生命的疾病的患者在没有其他令人满意的替代方案时，在临床试验之外获得试验性医疗产品。

The procedure was performed at Cleveland Clinic, one of the world's leading centers for cardiovascular care..

该手术在克利夫兰诊所进行，这是世界上领先的心血管护理中心之一。

'The successful treatment of this patient with severe functional mitral regurgitation represents a significant milestone for Mitria Medical,' said

“成功治疗这位严重功能性二尖瓣反流患者代表了Mitria Medical的一个重要里程碑，”

Rick Geoffrion, Chairman of the Board of Directors of Mitria Medical

里克·杰夫里昂，米特里亚医疗董事会主席

. 'We are honored to have worked with the world-class clinical team at Cleveland Clinic to provide our therapy to this patient. This success reinforces our confidence in the ability of the Subvalvular Spacer to address complex mitral valve regurgitation through a minimally invasive transcatheter approach.'.

“我们很荣幸能与克利夫兰诊所的世界级临床团队合作，为这位患者提供我们的治疗方案。这一成功进一步增强了我们对Subvalvular Spacer通过微创经导管方法解决复杂二尖瓣反流能力的信心。”

Mitral regurgitation is a debilitating condition where the heart's mitral valve does not close properly, allowing blood to flow backward into the heart's left atrium. If left untreated, it can lead to heart failure and death. Mitria Medical's SVS is a novel device designed to address posterior leaflet tethering, preserve anterior leaflet motion and provide an anatomically versatile transcatheter option for the treatment of functional mitral regurgitation (FMR)..

二尖瓣反流是一种严重的心脏疾病，患者的心脏二尖瓣无法正常关闭，导致血液倒流回左心房。如果不及时治疗，可能会导致心力衰竭甚至死亡。Mitria Medical的SVS是一种创新装置，旨在解决后叶牵拉问题，保留前叶运动，并为功能性二尖瓣反流（FMR）的治疗提供一种解剖学上通用的经导管选择。

'Although percutaneous treatment options for mitral regurgitation are available and well-established, there are patients who are ineligible for these therapies because of their anatomy. This new device may provide an important treatment option and help overcome some of the limitations of current therapies for patients with functional mitral regurgitation,' said .

“虽然二尖瓣反流的经皮治疗方案已经存在并且非常成熟，但由于解剖结构的原因，有些患者不适合接受这些治疗。这种新装置可能会提供一种重要的治疗选择，并有助于克服现有功能性二尖瓣反流治疗手段的一些局限性，”他表示。

Jose Navia, MD, Vice Chief, Heart, Vascular & Thoracic Institute, Cleveland Clinic Florida

何塞·纳维亚，医学博士，克利夫兰诊所佛罗里达州心脏、血管和胸腔研究所副所长

.

。

'Continued innovation is essential due to the complex morphology of mitral valve disease,' said

“由于二尖瓣疾病形态复杂，持续创新至关重要，”他说。

Samir Kapadia, MD, Chair, Department of Cardiovascular Medicine, Cleveland Clinic.

萨米尔·卡帕迪亚，医学博士，克利夫兰诊所心血管内科主任。

'The device performed as intended, and we are looking forward to further clinical evaluation of this promising technology.'

“该设备按预期运行，我们期待对该前景技术进行进一步的临床评估。”

The successful compassionate use case follows previous successful implantations of the Subvalvular Spacer in Tashkent, Uzbekistan and Asunción, Paraguay; experience with prior cases has been presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, the American Association for Thoracic Surgery's Mitral Conclave, and Miami Valves..

成功的同情使用案例之前在乌方别克斯坦塔什干和巴拉圭亚松森成功植入了瓣下间隔器；之前病例的经验已经在经导管心血管治疗（TCT）会议、美国胸外科协会的二尖瓣专题会议以及迈阿密心脏瓣膜会议上展示。

In 2019, Cleveland Clinic Innovations established Mitria Medical, Inc. as a Cleveland Clinic portfolio company to commercialize the SVS technology. Dr. Kapadia and Dr. Navia have equity ownership rights as co-inventors of the Subvalvular Spacer.

2019年，克利夫兰诊所创新机构成立了Mitria Medical公司，作为克利夫兰诊所旗下的投资组合公司，以将SVS技术商业化。Kapadia博士和Navia博士作为Subvalvular Spacer的共同发明人拥有股权所有权。

About Mitria Medical

关于米特里亚医疗

Mitria Medical is a privately held medical device company based in Cleveland, Ohio, that is developing a novel transcatheter repair solution for functional mitral regurgitation. The Subvalvular Spacer (SVS) is an investigational device designed as a nitinol braid that sits at the hinge of the posterior leaflet to provide broad support underneath the displaced leaflet to restore coaptation while preserving the valve's natural motion and orifice area..

Mitria Medical是一家总部位于俄亥俄州克利夫兰的私人医疗设备公司，正在开发一种用于功能性二尖瓣反流的新型经导管修复解决方案。Subvalvular Spacer（SVS）是一种研究性装置，设计为置于后叶铰链处的镍钛编织物，可在移位的瓣叶下方提供广泛支撑，以恢复瓣叶对合，同时保留瓣膜的自然运动和开口面积。

Contact

联系

Mitria Medical

米特里亚医疗

Email:

电子邮件：

[email protected]

[email protected]

SOURCE Mitria Medical, Inc.

来源：米特里亚医疗公司

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