Johnson & Johnson MedTech’s electrophysiology unit shared results from its inspIRE and admIRE studies. The inspIRE study looked at pulmonary vein isolation using a variable loop catheter with 3D mapping integration. The admIRE study used a variable loop circular catheter with 3D mapping integration.
Both trials used the Varipulse platform, which features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system. This platform holds approval in Japan, while it remains unavailable for sale in the EU and U.S.
Biosense Webster presented both sets of data at the 29th International AF Symposium last week.
“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 Jasmina Brooks, president, Biosense Webster. “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.”
Pulsed field ablation is one of the hottest spaces in medtech and Biosense Webster is looking to stake its claim. Boston Scientific picked up FDA approval for its Farapulse system last week. That came just over a month after Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib in December.
Biosense Webster has positive AFib freedom data from inspIRE
insPIRE evaluated the safety and effectiveness of Varipulse for treating drug-refractory paroxysmal AFib in Europe and Canada. 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%.
“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 Dr. Vivek Y. Reddy, 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.”
The company had positive early data from admIRE, too
admIRE pilot results showed that all pilot phase patients achieved acute success, Biosense Webster says. Additionally, four out of five remained free from atrial arrhythmia recurrence after one year.
One-year outcomes looked at 20 patients, all of whom achieved acute success from ablation procedures. The study had no procedure- or device-related primary adverse events during the pilot phase. Patients who received ablation recorded median procedure and fluoroscopy times of 90% and 3.5 minutes, respectively. The company attributed this to 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 Dr. David Newton, 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.”