The FieldForce catheter, a contact force PFA catheter optimized for the ventricles. [Image courtesy of Field Medical]Field Medical announced today that it received FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system.

FieldForce导管是一种针对心室优化的接触力PFA导管。[图片由Field Medical提供]Field Medical今天宣布，其FieldForce脉冲场消融（PFA）系统获得了FDA突破性设备指定。

The FDA also accepted the technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices.

FDA还将该技术纳入其产品全生命周期咨询计划（TAP）。TAP提供了FDA，患者，提供者和付款人的早期和频繁的战略参与。它促进了医疗设备的快速发展和广泛使用。

Field Medical was founded by Dr. Steven Mickelsen, the founder of Farapulse. Mickelsen also serves as CEO. He led his previous PFA technology developer to an acquisition by Boston Scientific in 2021. Boston Scientific, Medtronic and Johnson & Johnson MedTech now have their PFA technology FDA-cleared..

Field Medical由Farapulse的创始人Steven Mickelsen博士创立。米克尔森还担任首席执行官。2021年，他带领他之前的PFA技术开发人员被波士顿科学公司收购。Boston Scientific、Medtronic和Johnson＆Johnson MedTech现在已获得FDA的PFA技术批准。。

The FDA breakthrough nod and TAP acceptance cover the FieldForce system for sustained monomorphic scar-related ventricular tachycardia (VT). Field Medical says its system represents the first and only PFA system designed specifically for ventricular arrhythmia ablation.

FDA突破性的nod和TAP验收涵盖了用于持续性单形性瘢痕相关性室性心动过速（VT）的FieldForce系统。Field Medical表示，该系统是第一个也是唯一一个专门为室性心律失常消融设计的PFA系统。

Field Medical’s technology aims to become the first and only contact force PFA catheter optimized to work in the ventricle. It believes this could lead to predictable, time-efficient and safe treatment. Field Medical’s FieldBending technology utilizes non-intuitive physics to deliver intense, yet brief, electrical fields.

Field Medical的技术旨在成为第一个也是唯一一个优化用于心室工作的接触力PFA导管。它认为这可能会导致可预测的，省时且安全的治疗。Field Medical的FieldBending技术利用非直观的物理学来提供强烈但短暂的电场。

The company began first-in-human studies in May..

该公司于5月首次开始人体研究。

“The FDA’s TAP pilot acceptance and breakthrough device designation for the FieldForce ablation system represent pivotal milestones in our journey to regulatory approval,” said Mickelsen. “This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care.”.

Mickelsen说：“FDA对FieldForce消融系统的TAP试点验收和突破性设备指定代表了我们获得监管批准过程中的关键里程碑。”。“这一认识推进了我们为电生理学家配备下一代焦点PFA工具以实现快速，可访问的VT护理的愿景。”