Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial.

强生医疗科技公司（Johnson＆Johnson MedTech）的Biosense Webster今天宣布，它已完成其Omny IRE脉冲场消融（PFA）试验的注册。

The prospective, multi-center, non-randomized trial enrolled 188 patients in Europe and Canada. It evaluates the safety and effectiveness of the company’s Omnypulse platform. The J&J unit designed it for mapping and treating symptomatic paroxysmal AFib during standard ablation procedures.

这项前瞻性，多中心，非随机试验在欧洲和加拿大招募了188名患者。它评估了公司Omnypulse平台的安全性和有效性。强生部门设计它用于在标准消融程序中绘制和治疗症状性阵发性AFib。

Biosense Webster’s Omnypulse platform features the Omnypulse catheter and the Trupulse generator. The company offers the catheter as a large-tip, 12 mm device with Carto 3 system integration. It features contact force feedback and enhanced mapping capabilities.

Biosense Webster的Omnypulse平台具有Omnypulse导管和Trupulse发生器。该公司提供的导管作为一个大尖端，12毫米设备与Carto 3系统集成。它具有接触力反馈和增强的映射功能。

The investigational Tripulse generator delivers a bipolar, biphasic pulse sequence to the catheter’s 12 electrodes during cardiac ablation. It features contact force sensing and the Trueref reference electrode, reducing the impact of far-field unipolar signals. Biosense Webster said it designed the platform to enable AFib strategies with a single device.

在心脏消融期间，研究性三脉冲发生器向导管的12个电极提供双极双相脉冲序列。它具有接触力传感和Trueref参比电极，减少了远场单极信号的影响。Biosense Webster表示，它设计的平台可以通过单个设备实现AFib策略。

It combines a large ablation area with the ability to create high-density maps..

它将大的消融区域与创建高密度地图的能力相结合。。

Using PFA through the irreversible electrocorporation (IRE) process, the company says it could reduce the risk of damage to surrounding tissues. That includes esophageal, pulmonary vein and phrenic nerve injury.

该公司表示，通过不可逆电吸附（IRE）过程使用PFA可以降低周围组织受损的风险。包括食管、肺静脉和膈神经损伤。

“With the Omny-IRE trial now fully enrolled, we are continuing to make important progress in advancing our collective knowledge and understanding of PFA,” said Jennifer Currin, VP, scientific affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech. “Our hope is that the integrated Omnypulse platform will be an exciting new tool in a versatile portfolio of PFA solutions that Biosense Webster is advancing to provide electrophysiologists with a suite of tools they need to deliver optimal procedures for their patients.”.

强生医疗科技公司心血管与专业解决方案科学事务副总裁詹妮弗·柯林（JenniferCurrin）表示：“随着Omny IRE试验现已全部注册，我们正在继续在提高我们对PFA的集体知识和理解方面取得重要进展。”。“我们希望集成的Omnypulse平台将成为多功能PFA解决方案组合中令人兴奋的新工具，Biosense Webster正在推进该组合，为电生理学家提供为患者提供最佳程序所需的一套工具。”。

Biosense Webster earns coverage win in Japan

Biosense Webster在日本赢得报道

In addition to the Omnypulse news, Biosense Webster announced that Japanese authorities approved coverage of its Varipulse system.

除了Omnypulse新闻，Biosense Webster还宣布，日本当局批准了其Varipulse系统的报道。

From Sept. 1, 2024, the system — another PFA platform — will be covered by insurance in the country. It marks the first AFib treatment using PFA to earn insurance coverage in Japan.

。这标志着AFib在日本首次使用PFA获得保险。

The Varipulse system features the Varipulse catheter, a variable-loop multielectrode catheter. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system. Carto integration enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

Varipulse系统的特点是Varipulse导管，一种可变回路多电极导管。该平台还包括TruPulse发生器和Carto 3 3D心脏映射系统。Carto集成通过实时可视化和反馈机制实现了直观且可重复的工作流程。

The company designed Varipulse to enable pulmonary vein isolation with the versatility of a catheter loop, simple generator user interface and an intuitive mapping system. It also features contact indicators and PF tagging mechanisms..

该公司设计了Varipulse，通过导管回路的多功能性，简单的发生器用户界面和直观的映射系统实现肺静脉隔离。它还具有触点指示器和PF标记机制。。

The company submitted Varipulse for FDA approval at the end of March. If approved, Varipulse would become the third PFA system authorized for treating AFib, following Medtronic and Boston Scientific.

该公司于3月底将Varipulse提交给FDA批准。如果获得批准，Varipulse将成为继美敦力（Medtronic）和波士顿科学（Boston Scientific）之后第三个被授权用于治疗AFib的PFA系统。