HANGZHOU, China, June 14, 2024 /PRNewswire/ -- Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that its in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, VenusP-Valve, has completed its first implantation in the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine.

中国杭州，2024年6月14日/PRNewswire/--Venus Medtech（02500。香港）是中国经导管结构性心脏瓣膜治疗综合解决方案的领先供应商，今天宣布，其内部开发的创新经导管肺动脉瓣置换（TPVR）系统VenusP valve已完成其在弗吉尼亚大学医学院PROTEUS IDE关键临床研究中的首次植入。

This momentous procedure was performed by a multidisciplinary team coordinated by Prof. Scott Lim and Prof. Michael Hainstock of the center..

这一重要的过程是由该中心的ScottLim教授和Michael Hainstock教授协调的多学科团队完成的。。

This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.

这标志着VenusP阀在国际上取得了重大进展，也是继2022年4月CE MDR批准后的又一个里程碑。

The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation.

VenusP Valve PROTEUS研究是一项前瞻性多中心非随机介入研究，用于评估天然右心室流出道（RVOT）功能障碍患者的VenusP瓣膜系统的性能，该研究是对伴有中度或更大肺返流的RVOT疾病患者进行的。

With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve's registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA)..

目标招募60名受试者，该试验的数据将支持VenusP Valve在美国FDA和日本药品和医疗器械管理局（PMDA）的注册。。

In late 2023, the VenusP-Valve PROTEUS trial received coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS). With this endorsement, all eligible beneficiaries can be reimbursed for VenusP-Valve treatment in the study.

2023年末，VenusP Valve PROTEUS试验获得了美国医疗保险和医疗补助服务中心（CMS）的覆盖率批准。有了这个背书，所有符合条件的受益人都可以在研究中获得VenusP瓣膜治疗的报销。

Following its first clinical implantation in 2013, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia, with its implantation seeing continuous growth in new hospitals and centers..

在2013年首次临床植入后，VenusP瓣膜已在临床实践中应用了11年。迄今为止，该设备已被纳入德国、法国等国的国家健康保险计划，并已在中国、德国、法国、英国、意大利、西班牙、加拿大和澳大利亚等五十多个国家获得批准，其植入在新医院和中心不断增长。。

'We're honored to be part of the VenusP-Valve PROTEUS trial,' said Prof. Scott Lim after the procedure. 'We've just completed the first patient enrollment in that trial using the VenusP-Valve. This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease.'.

“我们很荣幸能参加VenusP Valve PROTEUS试验，”斯科特·林教授在手术后说我们刚刚使用VenusP瓣膜完成了该试验的首次患者登记。这效果很好，它确实代表了治疗严重肺动脉瓣疾病患者的更好方法的可能性。”。

'That went really smoothly in this teenage patient with free pulmonary insufficiency', commented Prof. Michael Hainstock. 'I'm very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease.'

迈克尔·海恩斯托克（MichaelHainstock）教授评论道：“这名患有自由肺功能不全的青少年患者的情况非常顺利。”我对阀门的部署和位置非常满意。这种（静脉瓣膜）是我们患者治疗肺动脉瓣疾病的另一种选择。”

'The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market,' said Lim Hou-Sen, General Manager and CEO of Venus Medtech. 'The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition.

Venus Medtech总经理兼首席执行官林侯森（LimHousen）说，Venus Medtech在美国首次成功植入Venus Valve PROTEUS研究，代表了Venus Medtech在这个关键市场上的一个重要里程碑该设备已经在许多情况下获得了FDA的同情使用批准，突显了其独特的临床优势和高度的监管认可。

Moving forward, we will redouble efforts to advance VenusP-Valve's clinical progress, speeding up its approval process with both the FDA and Japan's PMDA.'.

展望未来，我们将加倍努力推进VenusP瓣膜的临床进展，加快FDA和日本PMDA的批准程序。”。

About VenusP-Valve

关于VenusP阀

As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure.

作为中国和欧洲批准的第一款自膨式TPVR产品，VenusP瓣膜具有显着的临床价值。该产品独特设计，两端均为喇叭形，在流出端使用裸支架确保鳃动脉的血流。它提供了一个稳定的多点锚固系统，易于输送，无需在手术前进行预支架置入。

Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT..

VenusP瓣膜有多种规格，适用范围广，在大型RVOT的情况下，能够满足85%患者的需求。。

The long-term safety and efficacy of VenusP-Valve has been backed by impressive clinical data. According to three-year follow-up results of the clinical trial in Europe, the product demonstrated 100% procedural success and 0% all-cause mortality and reoperation among 81 patients who underwent TPVR. Right ventricular function improved significantly.

VenusP瓣膜的长期安全性和有效性得到了令人印象深刻的临床数据的支持。根据欧洲临床试验的三年随访结果，该产品在81例接受TPVR的患者中显示出100%的手术成功率和0%的全因死亡率和再次手术率。右心室功能明显改善。

Only one patient had severe pulmonary regurgitation..

只有一名患者出现严重的肺反流。。

About Venus Medtech

关于Venus Medtech

Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment..

Venus Medtech（杭州）有限公司致力于结构性心脏创新。我们正在开发结构性心脏病的综合解决方案并将其商业化。我们强大的管道涵盖了从TAVR、TPVR、TMVR和TTVR到高血压肾脏去神经支配（RDN）治疗的所有四个心脏瓣膜，突显了我们坚定不移的承诺。。

For more information, please visit https://www.venusmedtech.com

For more information, please visit https://www.venusmedtech.com

*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.

*本内容仅供参考和学术用途，不作为专业医疗或法律建议。Venus Medtech对本内容的完整性、准确性或及时性不作任何陈述、保证或保证。

*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.

*Venus Medtech对所提及的任何医疗器械的财产或临床性能不作任何陈述、保证或担保。

*VENUSMEDTECH, the stylized QI logo, VenusP-Valve, etc. are trademarks of Venus Medtech (Hangzhou) Inc.

*VENUSMEDTECH、QI标志、VenusP阀等是Venus Medtech（杭州）有限公司的商标。

Copyright 2024. Venus Medtech (Hangzhou) Inc. All Rights Reserved.

版权所有2024。Venus Medtech（杭州）有限公司。保留所有权利。

Contacts:

联系人：

Jill Liu

吉尔·刘

Public Relations

公共关系

liujie@venusmedtech.com

liujie@venusmedtech.com

Ophelia Chen

奥菲莉亚·陈

Investor Relations

投资者关系

chenwenjuan@venusmedtech.com

chenwenjuan@venusmedtech.com

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SOURCE Venus Medtech (Hangzhou) Inc.

来源：Venus Medtech（杭州）有限公司。

Company Codes: HongKong:2500

公司代码：香港：2500