Late-breaking data from inspIRE and admIRE clinical trials for Varipulse Platform presented at AF Symposium.- Biosense Webster J&J.

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 the inspIRE and admIRE studies were conducted using the Biosense Webster 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, which provides full integration with the world’s leading 3D cardiac mapping system. The Carto System enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

Data from inspIRE Demonstrate 80% of Patients Achieved Freedom from Recurrence with Zero Primary Adverse Events : The inspIRE study evaluated the safety and effectiveness of the Varipulse Platform for the treatment of drug-refractory paroxysmal AFib in Europe and Canada. In the study, 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 participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint. The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the Varipulse Platform to the Carto 3 System. The safety results demonstrated a primary adverse event rate of 0.0%.

“High efficacy of 80% freedom from atrial recurrence at 12 months and a strong safety profile are promising evidence of the capabilities of the Varipulse Platform,” said Vivek Y. Reddy, M.D., Director of Electrophysiology at the Mount Sinai Fuster Heart Hospital and The Helmsley Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, corresponding author for the inspIRE study publication.. “As the Varipulse Platform was designed to integrate seamlessly with the Carto 3 Mapping System, this technology should be able to effectively treat patients with atrial fibrillation with low radiation exposure to patients and lab staff alike.”

admIRE Pilot Results Show All Pilot Phase Patients Achieved Acute Success and 80% Remained Free from Atrial Arrhythmia Recurrence After One Year ; Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the Varipulse Platform among U.S. patients, were presented as a late-breaker at the AF Symposium. Among 20 patients who completed the 12-month follow-up visit, 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year. No procedure or device-related primary adverse events were reported in the pilot phase of the study. For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, as a result of the Carto integration.

“The results observed in the pilot phase of the admIRE study point to the promise of the Varipulse Platform in treating patients with paroxysmal AFib,” said David Newton, M.D., Clinical Cardiac Electrophysiologist, Memorial Health University Medical Center, Savannah, Georgia. “These initial results are encouraging and demonstrate the potential for the Varipulse Platform to become a key component of the suite of tools electrophysiologists have at their disposal to perform catheter ablations.”

AFib is the most common type of cardiac arrhythmia and affects more than 6 million people in the United States and nearly 38 million people worldwide. Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib. Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression. Catheter ablation is a safe and effective procedure when drugs don’t work to help restore the heart’s incorrect electrical signals, which cause an abnormal heart rhythm.