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 the third PFA system authorized for treating AFib. Boston Scientific won FDA approval for its Farapulse system last month. That came less than two months after Medtronic won the first FDA nod for PFA to treat paroxysmal and persistent AFib. Varipulse already holds approval in other geographies, including Europe and Japan.

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. According to Biosense Webster, Carto integration enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

Biosense Webster 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.

“The Varipulse platform, differentiated by its Carto 3 system integration and mapping capabilities, is part of a versatile portfolio of PFA tools that Biosense Webster is developing to meet the varied needs of electrophysiologists and their patients,” said Jasmina Brooks, president, Biosense Webster. “Based on the results from the admIRE clinical trial, we are confident that this innovation has the promise to deliver significant value and differentiated capabilities, and become an important tool for the treatment of AFib.”