Johnson & Johnson MedTech announced today that the FDA approved its Varipulse pulsed field ablation (PFA) platform for treating AFib. Varipulse treats AFib with a single device that combines PFA with the Carto 3 mapping system. With approval, Johnson & Johnson joins Medtronic and Boston Scientific as companies with PFA technologies approved for treating AFib. […]
Biosense Webster
J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial. 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 […]
The latest AI-powered cardiology devices you need to know
Artificial intelligence is increasingly becoming integral in advancing medtech, including devices to treat heart disease. Think AI-powered cardiology. AI-driven technologies could improve diagnostic capabilities, patient outcomes and clinical workflows. These technologies leverage machine learning algorithms and vast datasets to provide more accurate diagnoses and patient care. In cardiology, AI-powered devices are changing how heart conditions […]
The top stories out of Heart Rhythm Society 2024
Once again, the top players in cardiac care gathered en masse as Heart Rhythm Society (HRS) 2024 took place in Boston last week. From implantable rhythm management devices to AI-powered monitoring and diagnostic technology, Heart Rhythm 2024 had it all. Once again, pulsed field ablation (PFA) took center stage as companies continue to build on […]
Biosense Webster presents data backing Varipulse pulsed field ablation
Johnson & Johnson MedTech’s Biosense Webster today shared positive results from a clinical trial of its Varipulse pulsed field ablation (PFA) platform. The company presented results from its admIRE pivotal clinical trial and additional data from the Virtue study at HRS 2024. Both studies evaluated Varipulse for the treatment of cardiac arrhythmias, including AFib. Biosense Webster’s […]
Biosense Webster launches new AI-powered version of heart mapping tech
Johnson & Johnson MedTech’s Biosense Webster today announced the launch of the latest version of its Carto 3 heart mapping system. Carto 3 Version 8 offers 3D heart mapping for cardiac ablation procedures. Biosense Webster incorporates it into technology like the Varipulse pulsed field ablation (PFA) system, which is currently under FDA review. Biosense Webster added […]
Biosense Webster reports positive dual-energy ablation results
Johnson & Johnson’s Biosense Webster unit today announced positive three-month follow-up results from its SmartfIRE clinical trial. The study evaluated the use of the dual-energy ThermoCool SmartTouch SF catheter. ThermoCool SmartTouch SF is the first dual-energy pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index. Biosense Webster’s system in […]
J&J’s Biosense Webster submits Varipulse pulsed field ablation system for FDA approval
Johnson & Johnson MedTech’s Biosense Webster announced today that it submitted its Varipulse platform to the FDA for premarket approval. The company supported its PMA submission for the pulsed field ablation (PFA) system with results from the admIRE study. It aims to garner approval for the treatment of paroxysmal AFib. If approved, Varipulse would become […]
J&J Biosense Webster’s Varipulse PFA system wins CE mark
J&J MedTech’s Biosense Webster unit announced today that it won CE mark approval for its Varipulse pulsed field ablation (PFA) platform. European officials approved Varipulse for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. Varipulse features the Varipulse catheter, a variable-loop multielectrode catheter. The platform also includes TruPulse generator and the Carto […]
J&J’s Biosense Webster begins trial for Laminar left atrial appendage elimination device
Johnson & Johnson’s Biosense Webster today announced the start of patient cases with the investigational Laminar LAAX system. In November 2023, Johnson & Johnson MedTech completed a $400 million acquisition of Laminar, With that buy, the company brought in Laminar’s left atrial appendage elimination (LAAX) technology. Unlike other LAA technologies, which exclude or occlude the […]
Biosense Webster supports duo of new studies using Varipulse pulsed field ablation tech
Biosense Webster today announced its support for two collaborative studies using its Varipulse pulsed field ablation (PFA) platform. Johnson & Johnson MedTech’s electrophysiology unit says the two collaborative studies aim to better understand the use and workflows of the investigational platform in treating diverse arrhythmias. Varipulse features the Varipulse catheter, a variable-loop multielectrode catheter, the […]
