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Biosense Webster Announces Results From inspIRE and admIRE Clinical Trials

Image Credit: © photon_photo – stock.adobe.com

Biosense Webster has announced late-breaking data from company-sponsored inspIRE and admIRE clinical trials, which showed promising findings in the area of cardiac ablation, according to company press release.1 Results from the 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,” and admIRE study, “PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study,” were presented at 29th Annual International AF Symposium.

Atrial fibrillation (AFib), the most common type of arrythmia, is a type of irregular heartbeat that can lead to cardiac events, such as stroke and blood clots, if not treated. The CDC predicts that by 2030, approximately 12.1 million people in the United States will have developed the condition. Further, in 2019, AFib was mentioned on 183,321 death certificates in the United States was listed as the underlying cause of death for 26,535 of those cases.2

The CDC reports that AFib is the primary diagnosis for approximately 454,000 annual hospitalizations in the United States and it contributes to approximately 158,000 annual deaths. Concerningly, the death rate among individuals with AFib listed as the primary or contributing cause of death has been increasing for more than two decades.2

Both the inspire and admIRE studies were conducted using Biosense Webster’s VARIPULSE Platform, consisting of the VARIPULSE Catheter, a fully integrated variable-loop multielectrode catheter.

The inspIRE study evaluated the safety and effectiveness of the VARIPULSE Platform for the treatment of drug refractory paroxysmal AFib in Europe and Canada. Results over the course of 12 months showed the primary effectiveness endpoint of acute pulmonary vein isolation and freedom from atrial arrhythmia recurrence (AFib, atrial tachycardia, or atrial flutter) was 75.6%. In participants who received optimal PFA applications, 80% achieved the primary effectiveness endpoint.

“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 inspIRE study corresponding author Vivek Y. Reddy, MD, 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, in the press release.

Meanwhile, data from the 12-month pilot phase of the admIRE study, which tested the safety and efficacy of the VARIPULSE platform among US patients, showed all 20 participants who completed the 12-month follow-up visit achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence after one year.

“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, MD, Clinical Cardiac Electrophysiologist, Memorial Health University Medical Center, Savannah, Georgia, in the press release. “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.”

References

  1. Biosense Webster Presents Late-Breaking Data from inspIRE and admIRE Clinical Trials at AF Symposium. News release. February 2, 2024. Accessed February 5, 2024. https://www.jnjmedtech.com/en-US/news-events/biosense-webster-presents-late-breaking-data-inspire-and-admire-clinical-trials-af?utm_source=linkedin.com&utm_medium=social&utm_campaign=biosense_webster-na-2024-press_release
  2. US Centers for Disease Control and Prevention. Atrial Fibrillation. Webpage. Updated October 14, 2022. Access February 5, 2024. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm