Biosense Webster Unveils Late-Breaking Data from admIRE Trial at Heart Rhythm Society Meeting

Biosense Webster, Inc., a leader in cardiac arrhythmia treatment and a part of Johnson & Johnson MedTech, revealed groundbreaking results from the pivotal phase of the admIRE clinical trial at the Heart Rhythm Society (HRS) Annual Meeting in Boston. The trial explored the efficacy and safety of the VARIPULSE™ Pulsed Field Ablation (PFA) Platform in treating cardiac arrhythmias, including atrial fibrillation (AFib).

The admIRE trial assessed the VARIPULSE™ Platform over 12 months, involving 277 participants with paroxysmal AFib across 30 healthcare centers in the U.S., operated by 39 physicians. Key highlights from the trial include a 75% overall primary effectiveness success rate and a peak primary effectiveness of 85% for participants who received 73-96 PFA applications for pulmonary vein isolation (PVI). The trial also reported a low primary adverse event rate of 2.9% and no incidents of device or procedure-related deaths.

In terms of procedural outcomes, all patients achieved acute procedural success, with 98% first-pass isolation recorded per vein. The median procedure time was 81 minutes for PVI-only procedures and 90 minutes for all procedures, with a fluoroscopy time of just 7 minutes. Remarkably, 43% of patients were discharged on the same day as their procedure, and 25% of procedures were performed without fluoroscopy, thanks to the integration of the VARIPULSE™ Platform with the CARTO™ 3 System.

Vivek Reddy, M.D., emphasized the significant safety and effectiveness results of the VARIPULSE™ Platform. The primary effectiveness success rate stood at 74.6%, and among those who received 73-96 PFA applications, 85% achieved success. The trial also highlighted that 25% of procedures were conducted without fluoroscopy, underscoring the platform's advanced integration capabilities.

The admIRE trial results build on previous data from the inspIRE study, which evaluated the VARIPULSE™ Platform in Europe and Canada. This data forms part of Biosense Webster's global clinical trial strategy, including results from recent trials such as SmartfIRE, SmartPulse, and Omny-IRE.

Additionally, the VIRTUE study results were presented at the HRS Annual Meeting. This trial evaluated the VARIPULSE™ Platform in a broader clinical setting, including patients with paroxysmal and persistent atrial fibrillation as well as atypical atrial flutter. The study included 125 patients, of whom only 23% met the typical criteria for catheter ablation trials. Ablation beyond PVI was performed in 80% of participants, demonstrating the platform's versatility in treating various atrial arrhythmias.

Jennifer Currin, Ph.D., highlighted the comprehensive evidence generation strategy for PFA solutions, reaffirming the safety and efficacy of the VARIPULSE™ Platform. The breadth of data presented at the HRS meeting underscores Biosense Webster's commitment to advancing cardiac arrhythmia treatment.

Atrial fibrillation is the most common type of cardiac arrhythmia, affecting over 8 million people in the United States and nearly 50 million worldwide. Despite these numbers, many patients are unaware of their condition until complications arise. Catheter ablation, such as that offered by the VARIPULSE™ Platform, provides a safe and effective treatment option when medications fail.

The VARIPULSE™ Platform, comprising the VARIPULSE™ Catheter, TRUPULSE™ Generator, and the CARTO™ 3 Mapping System, recently received its first regulatory approval in Japan for treating symptomatic drug-refractory recurrent PAF using PFA. It also holds CE marks in Europe. In the U.S., the platform is under investigation and not yet approved by regulatory authorities. Biosense Webster has submitted the VARIPULSE™ Platform for Premarket Approval to the U.S. Food & Drug Administration.

The admIRE study aims to demonstrate the safety and long-term effectiveness of the VARIPULSE™ Platform for pulmonary vein isolation in patients with symptomatic drug-refractory paroxysmal AFib in the United States. The VIRTUE study, on the other hand, evaluates the platform's use in a broader range of atrial arrhythmias during clinically-indicated ablation procedures.

Biosense Webster, a part of Johnson & Johnson MedTech, continues to lead in cardiac arrhythmia diagnosis and treatment, advancing tools and solutions for improved patient care.