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 for its Farapulse system earlier this month. That came less than two months after Medtronic won the first FDA nod for PFA to treat paroxysmal and persistent AFib.
Biosense Webster supported European approval for Varipulse with data from the inspIRE trial. The inspIRE study looked at pulmonary vein isolation using a variable loop catheter with 3D mapping integration.
“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 visualization, in real-time.”
More about the data that led to PFA approval in Europe for Biosense Webster
insPIRE evaluated the safety and effectiveness of Varipulse for treating drug-refractory paroxysmal AFib in Europe and Canada. Biosense Webster presented positive data at this month’s AF Symposium.
The study evaluated 186 patients. It had a primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence. That includes AFib, atrial tachycardia or atrial flutter.
More than three-quarters (75.6%) of subjects reached that primary effectiveness endpoint. Among patients receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.
Biosense Webster reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of Varipulse to Carto 3. Saftey results demonstrated a primary adverse event rate of 0.0%.
“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 Dr. Tom De Potter, associate director, Cardiovascular Center, OLV Hospital 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 [AFib].”