Johnson & Johnson MedTech (J&J MedTech) has received approval from the US Food and Drug Administration (FDA) for an update to the irrigation flow rate of its Varipulse Platform.
The Varipulse Platform, which uses pulsed field ablation (PFA) technology, is said to have achieved over 10,000 procedures across multiple regions. These include the US, Europe, Canada, Japan, and Asia-Pacific markets.
Johnson & Johnson MedTech electrophysiology and neurovascular company group chair Michael Bodner said: “By learning from real-world experience and working closely with clinicians, we are continuously enhancing our technologies to improve patient care.
“This update to the Varipulse Platform reflects our ongoing commitment to lead the evolution of PFA through meaningful, data-driven improvements that advance product performance and build procedural confidence.”
Comprising the Varipulse Catheter, TRUPULSE Generator, and CARTO 3 Mapping System Varipulse Software, the platform is approved for use in the US, Europe, Asia-Pacific regions, and Canada.
It offers a pulmonary vein isolation solution integrated with the CARTO 3 System, powered by the TRUPULSE Generator.
The technology aims to streamline therapy delivery through simple integration within Johnson & Johnson MedTech’s portfolio. This integration allows for scaling between simple and complex ablations while potentially reducing procedural complexity and improving lab workflow.
Key features of the TRUPULSE Generator include auto-detection of connected catheters, loading of appropriate pulse sequences, software upgrades, and troubleshooting on screen. It also supports dual monitor connections for management across different locations and offers multilingual onscreen displays.
Earlier this month, the company launched the Varipulse Platform in the Asia-Pacific region for catheter ablation procedures addressing atrial fibrillation (AFib). AFib can lead to serious health risks such as stroke and heart failure.
The platform’s integration with the CARTO 3 System facilitates real-time visualisation during procedures, enhancing precision and efficiency for physicians treating AFib patients.
