Biosense Webster has announced the receipt of European CE mark approval for the Varipulse platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AF) using pulsed field ablation (PFA).
The Varipulse platform is comprised of the Varipulse catheter, a variable-loop multielectrode catheter; the Trupulse generator, a multichannel PFA generator; and Carto 3, 3D cardiac mapping system. The Varipulse platform is the first and only Carto-integrated PFA system, enabling an intuitive and reproducible workflow with real-time visualisation and feedback mechanisms.
The safety and efficacy of the Varipulse platform was investigated in the inspIRE trial, which included 186 patients in Canada and Europe. Updated one-year follow-up data was presented this month at the AF Symposium (1–3 February, Boston, USA), demonstrating that among participants receiving optimal PFA applications, 80% achieved freedom from recurrence with zero primary adverse events.
Furthermore, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, atrial tachycardia, or atrial flutter) was 75.6%.
The study reported a fluoroscopy time of 7.8 minutes, partly attributed to the integration of the Varipulse catheter to the Carto 3 system and a good safety profile with no (0%) primary adverse events reported.
“CE mark approval of the Varipulse platform represents a significant advance in catheter ablation technology, allowing electrophysiologists to offer patients in Europe pulsed field ablation treatment with real-time integrated 3D mapping,” said Tom De Potter (OLV Hospital Aalst, Aalst, Belgium). “Significantly, the Varipulse platform is fully integrated with the Carto 3 system, enabling a simplified workflow with minimal fluoroscopy time. Most importantly, the recent published data on the Varipulse platform demonstrates the safety using pulsed field ablation for patients being treated for AF.”
Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AF, by interrupting irregular electrical pathways in the heart by delivering either heat (radiofrequency ablation) or cold (cryoablation).
PFA represents a new approach to treating AF, utilising a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat through a process called irreversible electroporation (IRE). Because the pulsed field energy is minimally thermal, IRE offers the potential to reduce the risk of damage to surrounding tissues including oesophageal, pulmonary vein, and phrenic nerve injury.
“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 Jasmina Brooks, president, Biosense Webster. “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 visualisation, in real-time.”
The Varipulse platform is not available for sale in the USA.
