Biosense Webster

The Vaipulse pulsed field ablation platform now has regulatory approval to treat AFib in Europe. [Image courtesy of Biosense Webster]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 3 3D cardiac mapping system. According to Biosense Webster, Carto integration enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

In addition to European approval, Varipulse holds approval in Japan but remains investigational in the U.S. Biosense Webster hopes to become the third company to garner FDA approval for AFib-treating PFA technology. Boston Scientific won FDA approval …

The Varipulse pulsed field ablation system. [Image courtesy of Biosense Webster]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 TruPulse generator and the Carto 3 3D cardiac mapping system. This platform holds approval in Japan, while it remains unavailable for sale in the EU and U.S.

Earlier this week, Biosense Webster shared positive one-year results from multiple studies evaluating Varipulse. Both studies demonstrated significant freedom from AFib recurrence.

Pulsed field ablation is one of the hottest spaces in medtech. Biosense Webster hopes to use Varipulse to establish itself…

The Varipulse pulsed field ablation system. [Image courtesy of Biosense Webster]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 circular catheter with 3D mapping integration.

Both trials used the Varipulse platform, which features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system. This platform holds approval in Japan, while it remains unavailable for sale in the EU and U.S.

Biosense Webster presented both sets of data at the 29th International AF Symposium last week.

“Biosense Webster is committed to bringing forward a versat…

[Image courtesy of Biosense Webster]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 patient outcomes comparable to traditional procedures.

Biosense Webster says its workflow is the first and only of its kind available in a radiofrequency (RF) cardiac ablation device. The FDA approved this workflow last year and the company offers it with several products in its ablation portfolio. That includes the SmartTouch SF catheter, a commonly-used catheter for RF ablation compatible with the Carto 3 mapping system.

The company says its updated workflow shows that direct imaging guidance — like ultrasound — c…

The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]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 a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year.

Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texa…

The QDOT Micro catheter. [Image courtesy of Biosense Webster]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) ablation catheter, utilizes advanced, high-energy ablation. It offers improved temperature monitoring, optimized irrigation and higher signal resolution. In QMODE+, it enables the delivery of ablation at 90 watts for up to four seconds. Standard QMODE delivers RF ablation using up to 50 watts for up to 60 seconds. The QDOT Micro catheter received CE Mark in 2020 and FDA approval in 2022.

Q-FFICIENCY evaluated the catheter’s safety and 12-month efficacy in patients with paroxysmal AFi…

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 association with lower heart failure risks compared to AAD only.

Biosense Webster says that several clinical studies highlight catheter ablation as a safe and superior alternative to AAD when performed appropriately. However, the company says less than 5% of the eligible population receive the procedure.

The study used the 2014-2022 Optum Clinformatics database to identify adult patients with AFib who previously used AAD. It classified them into two cohorts: those treated with catheter ablation versus those who received an AAD. The study matched the grou…