Biosense Webster, a Johnson & Johnson MedTech company, revealed the first patient cases using its investigational Dual Energy ThermoCool SmartTouch SF (Dual Energy STSF) catheter took place, as part of its SmartPulse pivotal study to treat paroxysmal atrial fibrillation (AFib). .

强生医疗技术公司Biosense Webster透露，作为其SmartPulse治疗阵发性心房颤动（AFib）关键研究的一部分，首次使用其研究性双能ThermoCool SmartTouch SF（双能STSF）导管治疗患者。。。

The SmartPulse study will enroll about 250 patients with paroxysmal AFib in the U.S. to evaluate its safety and effectiveness.

SmartPulse研究将在美国招募约250名阵发性AFib患者，以评估其安全性和有效性。

The Dual Energy STSF catheter is a focal, contact force sensing catheter that can deliver both radiofrequency (RF) and pulsed field ablation (PFA) energy. Its TruPulse generator provides RF and PFA by toggling the two energy sources on a generator monitor.

双能STSF导管是一种局灶性接触力传感导管，可以提供射频（RF）和脉冲场消融（PFA）能量。它的TruPulse发生器通过在发生器监视器上切换两个能源来提供RF和PFA。

Both the catheter and generator are integrated with the company’s Carto 3 mapping system for 3D visualization with minimal fluoroscopy. The platform also integrates contact force measurement and ablation indexes for RF and PFA which can be used for lesion creation.

导管和发生器均与该公司的Carto 3映射系统集成，以实现3D可视化，并具有最小的透视效果。该平台还集成了射频和PFA的接触力测量和消融指标，可用于病变创建。

“The THERMOCOOL SMARTTOUCH SF Catheter is the most commonly used ablation catheter globally.iii By bringing the benefits of RF and PFA to a single catheter that EPs are accustomed to, we are giving physicians control of their preferred energy source and offering a point-by-point workflow that many prefer,” said Jasmina Brooks, president of Biosense Webster.

Biosense Webster总裁Jasmina Brooks说：“THERMOCOOL SMARTTOUCH SF导管是全球最常用的消融导管。iii通过将射频和PFA的优点引入EPs习惯的单一导管，我们可以让医生控制他们首选的能量来源，并提供许多人更喜欢的逐点工作流程。”。

“SmartPulse is the latest study in a robust global clinical trial program for the Biosense Webster investigational PFA portfolio aimed at ensuring our differentiated platform gives EPs the tools and information they need in real-time to deliver the best possible patient care.”  .

“SmartPulse是针对Biosense Webster研究PFA投资组合的强大全球临床试验计划中的最新研究，旨在确保我们的差异化平台为EPs提供实时所需的工具和信息，以提供最佳的患者护理。”。。

In July 2023, Biosense Webster completed enrollment of the SmartfIRE study, which is evaluating safety and efficacy of the Dual Energy STSF catheter to treat of drug refractory symptomatic paroxysmal AFib in Europe.

2023年7月，Biosense Webster完成了SmartfIRE研究的注册，该研究正在评估双能STSF导管在欧洲治疗药物难治性症状性阵发性AFib的安全性和有效性。

Earlier this week, Medtronic received the first U.S. Food and Drug Administration (FDA) approval for pulsed field ablation (PFA) technology.

本周早些时候，美敦力首次获得美国食品和药物管理局（FDA）对脉冲场消融（PFA）技术的批准。