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AF Symposium 2024: Biosense Webster Presents Late-Breaking Data from inspIRE and admIRE Clinical Trials
Irvine, CA – February 2, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced 12-month results from the company-sponsored 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,” presented as a late-breaking presentation at the 29th Annual International AF Symposium.1 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.2
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.
“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, Inc. “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.”
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.1 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.1 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%ii.1
“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.iii “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.2 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.2 No procedure or device-related primary adverse events were reported in the pilot phase of the study.2 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.2
“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.iv “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.3,4 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.5 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.6 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.7
About inspIRE
The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by PFA System With Irreversible Electroporation [IRE]) (NCT04524364) was a prospective, multi-center, single-arm study of drug-refractory PAF, conducted at 13 institutions in Canada and Europe, from March 2021 to May 2022. In the study, PVI was performed with the VARIPULSE™ Platform. Follow up with 24-hour Holter monitoring was performed at three, six, and 12 months. Remote rhythm monitoring was performed weekly from three to five months; monthly, from six to 12 months; and for symptoms. The primary effectiveness endpoint (PEE) was acute PVI plus freedom from all atrial arrhythmia (AFib, Atrial Tachycardia, or Atrial Flutter), at 12 months. This final analysis of the study focused on the pivotal phase (Wave II) per-protocol population of 186 patients with 12 months of follow up.
About admIRE
The admIRE study (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Biosense Webster IRE Ablation System) (NCT05293639) is a prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the VARIPULSE™ Platform when used for isolation of pulmonary veins in treatment of patients in the United States with symptomatic drug refractory paroxysmal AFib. Pulmonary vein isolation (PVI) was achieved using the VARIPULSE™ Platform. The study consisted of a pilot phase, which assessed initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance goals. The primary safety endpoint was incidence of early onset (within seven days) primary adverse events; atrio-esophageal fistula (within 90 days); cardiac tamponade or perforation (within 30 days); and PV stenosis (within 12 months). Acute procedure success (defined as confirmed entrance block at the end of procedure) and freedom from documented atrial arrhythmia recurrence at 12 months were also assessed.
About the VARIPULSE™ Platform
The VARIPULSE™ Platform is Biosense Webster’s Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory authorities. In Europe, the TRUPULSE™ generator received CE mark in late 2023 and VARIPULSE™ Catheter is pending CE mark.
1. Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston.
2. Newton D, Natale A, Mansour M, Nair D, Senn T. Pulsed Field Ablation Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study [abstract]. In: AF Symposium.; February 2-4; Boston.
3. Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964. PMID: 31955707.
4. Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340
5. Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ 2018;361:k1453 doi: 10.1136/bmj.k1453
6. Kuck KH, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace 2021;23(3)362-369. doi: 10.1093/europace/euaa298.
7. Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 2014;64(7),647–656. doi: 10.1016/j.jacc.2014.04.072
