Biosense Webster announced positive one-year results from multiple studies evaluating the Varipulse pulsed-field ablation (PFA) system.
Johnson & Johnson MedTech’s Electrophysiology Division shared results from the inspiIRE and admIRE studies. The inspire study investigated 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 studies used the Varipulse platform with a Varipulse catheter, variable loop multielectrode catheter, TruPulse generator, and Carto 3 3D cardiac mapping system. The platform has been approved in Japan, but remains unavailable for sale in the EU and US.
Biosense Webster presented both datasets at the 29th International AF Symposium last week.
“BioSense Webster is committed to advancing our portfolio of versatile and differentiated PFA solutions designed to help electrophysiologists deliver safe, effective and efficient cardiac ablation procedures. ” said Jasmina Brooks, President of Biosense Webster. “The encouraging results from the Varipulse clinical trial make us even more excited as we continue to deliver innovations that meet the diverse needs and ablation strategies needed to successfully treat atrial fibrillation. .”
Pulsed field ablation is one of the hottest areas in medical technology, and Biosense Webster is looking to stake its claim. Boston Scientific received FDA approval for its Farapulse system last week. The announcement comes just over a month after Medtronic became the first company to receive FDA approval for PFA to treat paroxysmal and persistent atrial fibrillation in December.
Biosense Webster receives positive AFib degrees of freedom data from inspiIRE
insPIRE evaluated the safety and efficacy of Varipulse in the treatment of drug-resistant paroxysmal atrial fibrillation in Europe and Canada. The primary efficacy endpoint was 12 months free of acute pulmonary vein isolation and atrial arrhythmia recurrence. This includes AFib, atrial tachycardia, or atrial flutter.
More than three-quarters (75.6%) of subjects met its primary efficacy endpoint. Among patients who received optimal PFA, 80% met the primary efficacy endpoint.
Biosense Webster reported a short viewing time of 7.8 minutes, due in part to Varipulse’s integration into Carto 3. Safety results demonstrated a major adverse event rate of 0.0%.
“The high efficacy and strong safety profile of 80% freedom from atrial recurrence at 12 months of age is promising evidence of the functionality of the Varipulse platform,” said Vivek Y., director of electrophysiology at Mount Sinai Faster Heart Hospital. Dr Reddy says. Helmsley Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai and corresponding author of inspiIRE research publications. “Because the Varipulse platform is designed to integrate seamlessly with his Carto 3 mapping system, this technology should be able to effectively treat atrial fibrillation patients with low radiation exposure for both patients and laboratory staff. ”
The company also had early positive data from admIRE
AdmIRE trial results showed acute success in all patients in the trial, Biosense Webster said. Additionally, 4 out of 5 patients had no recurrence of atrial arrhythmia after 1 year.
The 1-year results included 20 patients, all of whom had acute success with the ablation procedure. There were no major procedure- or device-related adverse events in this study during the pilot phase. Patients who underwent ablation recorded a median procedure time of 90% and a median fluoroscopy time of his 3.5 minutes. The company attributes this to the Carto integration.
“The results observed in the pilot phase of the admIRE study demonstrate the promise of the Varipulse platform in the treatment of patients with paroxysmal atrial fibrillation,” said Dr. M., a clinical cardiac electrophysiologist at Memorial Health University Medical Center in Savannah, Georgia. said Dr. David Newton. “These initial results are encouraging and demonstrate the potential of the Varipulse platform to become a key component of the suite of tools at electrophysiologists’ disposal to perform catheter ablations.”
