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 […]
Biosense Webster
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 […]
Biosense Webster has positive Varipulse pulsed field ablation data
Biosense Webster announced positive one-year results from multiple studies evaluating its Varipulse pulsed field ablation (PFA) system. Johnson & Johnson MedTech’s electrophysiology unit shared results from its inspIRE and admIRE studies. The inspIRE study looked at pulmonary vein isolation using a variable loop catheter with 3D mapping integration. The admIRE study used a variable loop […]
Study backs Biosense Webster low/zero fluoroscopy AFib ablation
Johnson & Johnson MedTech’s Biosense Webster announced positive findings from real-world data looking at its AFib ablation technology. The study evaluated the safety and effectiveness of low/zero fluoroscopy AFib ablation. Results supported the use of workflows to reduce radiation exposure during catheter ablation for treating paroxysmal AFib. Data also showed sustained safety, efficacy and long-term […]
Biosense Webster wins Japanese approval for Varipulse pulsed field ablation
Johnson & Johnson MedTech’s Biosense Webster today announced Japanese approval for its Varipulse platform for treating AFib. Varipulse treats symptomatic drug-refractory recurrent paroxysmal AFib using pulsed field ablation (PFA). The platform features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system. Biosense Webster says this marks […]
The top medtech trends of 2023
The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods. With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more. Here are the top stories […]
J&J’s Biosense Webster treats first patients in dual-energy AFib ablation trial
Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become […]
Biosense Webster has positive data for QDOT Micro ablation catheter
Johnson & Johnson MedTech’s Biosense Webster today announced new findings supporting the use of its QDOT Micro catheter. Published in the Journal of Cardiovascular Electrophysiology, the results demonstrate improved AFib control. They also showed relief of symptoms and overall quality of life improvements with QDOT Micro ablation treatment. The QDOT Micro catheter, a next-generation radiofrequency (RF) […]
Biosense Webster: Catheter ablation leads to lower heart failure risk in AFib patients
Johnson & Johnson’s Biosense Webster today announced data supporting the use of catheter ablation in AFib patients. The study, funded by the Irvine, California-based company, looked at heart failure incidence risks in AFib patients. It compared the use of catheter ablation versus antiarrhythmic drugs (AAD). Looking at non-specific catheter claims information, it showed catheter ablation’s […]