J&J’s Biosense Webster Nabs EU Nod for Varipulse Pulsed Field Ablation

Johnson & Johnson MedTech company Biosense Webster has earned CE mark approval for its Varipulse pulsed field ablation (PFA) platform to treat symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib).
 
Varipulse’s safety and efficacy leading to EU approval was investigated in the inspIRE trial of 186 patients in Canada and Europe. One-year follow-up data was presented at this month’s AF Symposium, showing 80% of participants receiving optimal PFA applications had no recurrence and no primary adverse events.
 
Further, the primary effectiveness endpoint of the trial—acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence—was 75.6%. A 7.8 minute fluoroscopy time due to the Varipulse catheter’s integration with the Carto 3 system was also reported.
 
“At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation. CE mark approval of the VARIPULSE Platform is testament to this, now offering healthcare professionals the potential to improve outcomes for people living with atrial fibrillation while setting a new standard in cardiac electrophysiological mapping,” said Biosense Webster president Jasmina Brooks. “We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows, and the VARIPULSE Platform uniquely offers physicians a simple and reproducible PFA workflow with 3D visualization, in real-time.”

More on Pulsed Field Ablation

Pulsed-field ablation (PFA) is a new, promising ablation modality to treat atrial fibrillation (AFib). It’s an adaptation of direct current ablation—the first energy source used for catheter ablation—used in the 1980s to treat cardiac arrhythmias. That ablative method was replaced by radiofrequency (RF) energy because it’s more efficient and precise.
 
PFA applies more controlled high-intensity pulses over a very short time, and represents the field’s next major advance. It’s a more tissue-specific form of energy delivery than thermal—during PFA, adjacent myocardial cell membranes are destabilized, which results in nanoscale pores, increased cell membrane permeability, and leakage of cell contents. This results in “selective ablation”—either immediate necrosis or delayed, orchestrated cell collapse.
 
The market is a hot one for the major medical device makers: rivals Medtronic, Boston Scientific, and Abbott are active in the new PFA space.