Sam Brusco, Associate Editor02.05.24
Johnson & Johnson MedTech’s Biosense Webster revealed 12-month results from its company-sponsored inspIRE study, "Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation (PFA) Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE."
The results were a late-breaking presentation at the 29th Annual International AF Symposium. Interim results from the company-sponsored admIRE study, titled "PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study," were also shared in a late-breaking presentation.
Both studies were conducted using the company’s Varipulse Platform, consisting of the Varipulse catheter—a fully integrated variable-loop multielectrode catheter; the Trupulse generator—a multichannel PFA generator; and the Carto 3 System Varipulse service pack software. The Varipulse platform earned approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) in January 2024.
The pilot phase of the study assessed safety and efficacy of the Varipulse platform among U.S. patients.
"Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures," said Biosense Webster’s president Jasmina Brooks. "The encouraging outcomes from clinical trials with Varipulse fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation."
The results were a late-breaking presentation at the 29th Annual International AF Symposium. Interim results from the company-sponsored admIRE study, titled "PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study," were also shared in a late-breaking presentation.
Both studies were conducted using the company’s Varipulse Platform, consisting of the Varipulse catheter—a fully integrated variable-loop multielectrode catheter; the Trupulse generator—a multichannel PFA generator; and the Carto 3 System Varipulse service pack software. The Varipulse platform earned approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) in January 2024.
inspIRE Data
The study evaluated Varipulse to treat drug-refractory, paroxysmal atrial fibrillation (AFib) in Europe and Canada.- The primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AFib, atrial tachycardia, or atrial flutter) was 75.6%.
- Among those receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.
- The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to integration of the Varipulse platform to Carto 3.
- The safety results demonstrated a primary adverse event rate of 0.0%.
admIRE Pilot Results
The pilot phase of the study assessed safety and efficacy of the Varipulse platform among U.S. patients.- Among 20 patients who completed the 12-month follow-up visit, 100% had acute success from ablation procedures and 80% stayed free from atrial arrhythmia recurrence at one year.
- No procedure or device-related primary adverse events were reported in the pilot phase.
- For patients who received ablation, median procedure and fluoroscopy times were 90 and 3.5 minutes, respectively, as a result of the Carto integration.
"Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures," said Biosense Webster’s president Jasmina Brooks. "The encouraging outcomes from clinical trials with Varipulse fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation."