Biosense Webster Announces FDA Submission for Approval of the Varipulse Platform

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All 20 participants in a 12-month follow-up study attained acute success from ablation procedures.

Researchers from Biosense Webster, part of Johnson & Johnson MedTech, announced that they have submitted a premarket approval application (PMA) to the FDA for their Varipulse Platform that treats paroxysmal atrial fibrillation (AFib).

Anatomy of Human Heart on medical background. 3d render. Generative Ai. - Image credit: ckybe | stock.adoe.com

Image credit: ckybe | stock.adoe.com

The Varipulse Platform is an irreversible electroporation ablation system that includes the Varipulse Catheter, the Trupulse Generator, and the Carto 3 Mapping System Varipulse, according to study authors. The platform is designed to provide a 3D cardiac mapping system that was intended to enable pulmonary vein isolation with the adaptability of a catheter loop. The platform offers “reproducible workflow with real-time visualization, contact indicator, and [pulsed field] tagging mechanisms,” noted study authors.

About the admIRE Trial

Trial Name: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System

ClinicalTrials.gov ID: NCT05293639

Sponsor: Biosense Webster, Inc.

Competition Date (Estimated): January 2024

“The VARIPULSE™ Platform, differentiated by its CARTO 3 System integration and mapping capabilities, is part of a versatile portfolio of [pulsed field ablation] tools that Biosense Webster is developing to meet the varied needs of electrophysiologists and their patients,” said Jasmina Brooks, President, Biosense Webster, Inc., in a press release.

Findings from the prospective, multicenter, single arm, admIRE study (NCT05293639) supported the PMA submission. The study assessed the safety and long-term effectiveness of the Varipulse platform when used to isolate pulmonary veins among US individuals with symptomatic drug refractory paroxysmal AFib, according to study authors. The pilot phase of the study evaluated the initial device safety and effectiveness, and the pivotal phase analyzed these compared to pre-specified performance goals.

AFib impacts more than 6 million individuals in the US and almost 38 million individuals globally, as the most common form of cardiac arrhythmia. Despite the large impact, many individuals are unaware of symptoms, treatment options, and early treatment to mitigate disease progression, according to study authors.

The study authors noted that data from 12-month outcomes were included in the pilot phase which included 20 individuals who underwent a 12- month follow-up visit. Among the individuals, 100% attained acute success from ablation procedures, defined as a confirmed entrance block after completing the procedure. Following, 80% of individuals were reported to remain free from atrial arrhythmia recurrence at 1 year, according to study authors.

Among individuals that received ablation, the median procedure and fluoroscopy times were reported to be 90.00 and 3.5 minutes, which could be connected to addition with the Carto System, according to study authors.

However, the study authors noted that no device or procedure related primary adverse events were reported throughout the pilot phase of the admIRE trial.

“Based on the results from the admIRE clinical trial, we are confident that this innovation has the promise to deliver significant value and differentiated capabilities and become an important tool for the treatment of AFib,” said Brooks, in a press release.

Reference
Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE™ Platform for the Treatment of Paroxysmal Atrial Fibrillation. Johnson & Johnson MedTech. News release. March 25, 2024. Accessed March 26, 2024. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.investor.jnj.com/files/doc_news/2024/Mar/25/varipulse-fda-submission.pdf.
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