MARLBOROUGH, Mass., Aug. 27, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has obtained CE mark for the ACURATE Prime™ Aortic Valve System, the newest transcatheter aortic valve replacement (TAVR) technology in the company's structural heart portfolio. The ACURATE Prime valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy..

马萨诸塞州马尔伯勒（MARLBOROUGH），2024年8月27日/PRNewswire/--波士顿科学公司（NYSE:BSX）今天宣布，它已获得ACURATE Prime™主动脉瓣系统的CE标志，这是该公司结构性心脏投资组合中最新的经导管主动脉瓣置换术（TAVR）技术。ACURATE Prime valve系统设计有几个功能，以ACURATE neo2™平台的临床性能为基础，包括额外的瓣膜尺寸，将治疗范围扩大到解剖结构较大的患者。。

The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis. With a self-expanding, supra-annular design, this device has an enhanced frame that equalizes force across the valve for a stable fit against the native, diseased valve.

。该装置采用自膨胀的超环形设计，具有增强的框架，可均衡阀门上的力，以稳定地适应天然的患病阀门。

It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes..

它还为医生提供了重新设计的部署机制，用于高度准确的瓣膜定位，以帮助确保患者取得积极的结果。。

'The introduction of the ACURATE Prime technology offers physicians a TAVR option designed for streamlined procedural preparation, improved performance in complex cases and simplified delivery for quick and controlled deployment,' said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific.

波士顿科学公司介入心脏病学治疗首席医疗官Janar Sathananthan医学博士说：“ACURATE Prime技术的引入为医生提供了一种TAVR选项，旨在简化程序准备，改善复杂病例的表现，简化交付，以实现快速和可控的部署。”。

'Further, our clinical experience with the valve to date has shown the ability for precise positioning of the device in a broader population of patients, allowing more clinicians to consider this technology for treatment in challenging or larger heart structures.'.

“此外，我们迄今为止对该瓣膜的临床经验表明，该装置能够在更广泛的患者群体中精确定位，使更多的临床医生能够考虑将该技术用于具有挑战性或更大的心脏结构的治疗。”。

The ACURATE Prime valve system will now be available for the treatment of aortic annulus diameters between 20.5 and 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates,1,2 strong hemodynamic performance,1 as well as unrestricted coronary access for future procedures..

ACURATE Prime瓣膜系统现在将可用于治疗20.5至29 mm之间的主动脉瓣环直径。它还将具有ACURATE neo2平台全球研究中证明的许多设计特征和临床结果，包括低起搏器和瓣周漏率，1,2强血流动力学表现，1以及未来手术中不受限制的冠状动脉通路。。

'We are thrilled to offer physicians a new valve with meaningful improvements for the treatment of an increasing number of patients with aortic valve disease,' said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. 'Built on the ACURATE valve platform, which has been implanted in nearly 80,000 patients globally to date, the ACURATE Prime valve system is engineered to improve long-term cardiac function and provide access for future treatment needs, thereby supporting the lifetime management of these patients.'.

ACURATE Prime瓣膜系统建立在迄今为止已在全球近80000名患者中植入的ACURATE瓣膜平台上，旨在改善长期心脏功能，并为未来的治疗需求提供通路，从而支持这些患者的终身管理。”。

The company will initiate the launch of the ACURATE Prime valve system in Europe in the coming weeks. For more information on the system, visit https://www.bostonscientific.com/en-EU/medical-specialties/structural-heart/tavi-acurate-prime.html.

该公司将在未来几周在欧洲启动ACURATE Prime valve系统。有关系统的更多信息，请访问https://www.bostonscientific.com/en-EU/medical-specialties/structural-heart/tavi-acurate-prime.html.

*In Europe, the ACURATE neo2™ Aortic Valve System and the ACURATE Prime™ Aortic Valve System are CE-marked. In the USA, the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices and are restricted under federal law to investigational use only. Not available for sale..

*。在美国，ACURATE neo2主动脉瓣系统和ACURATE Prime主动脉瓣系统是研究设备，根据联邦法律仅限于研究使用。不可出售。。

About Boston ScientificBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care.

关于波士顿科学波士顿科学通过创新的医疗技术改变生活，改善世界各地患者的健康。作为全球医疗技术领导者已有45多年的历史，我们通过提供广泛的高性能解决方案来解决未满足的患者需求并降低医疗保健成本，从而推动生命科学的发展。