Boston Scientific Corporation  announced it has received FDA approval for the navigation-enabled Farawave NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation (AF) and FDA 510(k) clearance for the new Faraview Software, which will combine to provide visualization for cardiac ablation procedures with the Farapulse Pulsed Field Ablation (PFA) System.

波士顿科学公司（Boston Scientific Corporation）宣布，其已获得FDA批准用于治疗阵发性心房颤动（AF）的导航功能Farawave NAV消融导管和FDA 510（k）新Faraview软件的许可，该软件将结合Farapulse脉冲场消融（PFA）系统为心脏消融程序提供可视化。

These technologies are compatible exclusively with Boston Scientific's existing cardiac mapping technology and the company's latest offering, the Opal HDx Mapping System.

这些技术与Boston Scientific现有的心脏标测技术和该公司最新产品Opal HDx标测系统完全兼容。

Today, physicians may utilize a separate mapping catheter prior to a cardiac PFA procedure to examine and analyze the heart's electrical patterns and plan the therapeutic applications for each patient. The Farawave NAV Ablation Catheter builds upon the current Farawave catheter by adding magnetic navigation capabilities, enabling cardiac mapping and PFA therapy delivery within a single integrated catheter, while minimizing the need for additional device exchanges.

今天，医生可以在心脏PFA手术之前使用单独的标测导管来检查和分析心脏的电模式，并为每位患者计划治疗应用。Farawave NAV消融导管通过添加磁导航功能，在当前Farawave导管的基础上构建，从而在单个集成导管内实现心脏标测和PFA治疗输送，同时最大程度地减少对额外设备交换的需求。

Mapped procedures with the Farapulse PFA System are visually depicted for physicians via the Faraview Software, which offers a dynamic view of catheter placement, shape and rotation..

Farapulse PFA系统的映射程序通过Faraview软件为医生直观地描述，该软件提供了导管放置，形状和旋转的动态视图。。

'The addition of the Farawave NAV Ablation Catheter and Faraview Software to our portfolio provides a next-level pulsed field ablation mapping experience with cost-effective tools developed specifically and uniquely for the Farapulse PFA System,' said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific.

波士顿科学公司（Boston Scientific）电生理学总裁尼克·斯帕迪亚·阿内洛（Nick Spadea Anello）说：“在我们的产品组合中增加了Farawave NAV消融导管和Faraview软件，为Farapulse PFA系统专门开发了具有成本效益的工具，为我们提供了更高水平的脉冲场消融测绘体验。”。

'Built on this safe and clinically-proven platform – which has been used to treat more than 125,000 patients globally – the visualization capabilities offered by these new technologies are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures.'.

“建立在这个安全且经过临床验证的平台上，该平台已被用于治疗全球超过125000名患者，这些新技术提供的可视化功能旨在提高治疗提供的信心，并简化PFA程序期间的映射工作流程。”。

The latest advancement within the Boston Scientific PFA portfolio, the Faraview Software magnetically tracks the Farawave NAV Ablation Catheter, which allows physicians to see where pulsed fields have been applied and visualize cumulative therapy delivery to guide ablation strategy. Delivery of PFA with the Farawave NAV Ablation Catheter can be tracked through automated tagging technology, which is intended to assist physicians in planning, executing and confirming application of therapy by showing the approximate pulsed field locations within the heart, based on the catheter's position..

Faraview软件是波士顿科学PFA投资组合中的最新进展，它可以磁性地跟踪Farawave NAV消融导管，使医生能够看到脉冲场的应用位置，并可视化累积治疗的提供，以指导消融策略。。。

'In clinical use, the Faraview Software and Farawave NAV Ablation Catheter produced detailed cardiac maps that could improve guidance, limit fluoroscopy times and assist physicians in assessing the location of energy delivered during PFA procedures,' said Vivek Reddy, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York.

纽约西奈山福斯特心脏医院电生理主任维韦克·雷迪医学博士说：“在临床应用中，法拉维软件和法拉维导航消融导管产生了详细的心脏图，可以改善指导，限制透视时间，并帮助医生评估PFA手术过程中输送能量的位置。”。

'The addition of navigation and visualization capabilities to the Farapulse PFA System could aid workflow efficiency and enhance the treatment physicians can provide to patients living with AF.'.

“Farapulse PFA系统增加了导航和可视化功能，可以帮助提高工作流程的效率，并增强医生可以为房颤患者提供的治疗。”。