Johnson & Johnson's Biosense Webster Reports Zero Major Adverse Events with VARIPULSE PFA System in InspIRE and admIRE Trials

Feb 07, 2024 11:07 CST Updated 11:07

Johnson & Johnson

Medical Device R&D and Manufacturer

Source of the article:Heart NotCome;Editor:Liu Xinyi

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Heart Future

Recently,Johnson & Johnson (NYSE: JNJ)Under its umbrellaBiosense Webster, a subsidiary focused on electrophysiologyAnnounced the evaluation of itsVARIPULSE Pulsed Field Ablation (PFA) SystemThe two studies ofOne-Year Interim Results。

The names of these two studies are respectivelyinspIREAndadmIRE, Data was shared by Biosense Webster at the 29th International Symposium on Atrial Fibrillation (February 1-3).

Both studies used the full setVARIPULSESystem, namely the VARIPULSE catheter, TRUPULSE generator, and the service package software installed on the CARTO 3 mapping system.

# VARIPULSE System and Atrial Fibrillation

Pulse Field Ablation Mainly TargetsAtrial Fibrillation, the most common type of arrhythmia, affects more than 6 million people in the United States and nearly 38 million people worldwide. Approximately one in four adults over the age of 40 are at risk of developing atrial fibrillation. U.S. President Joe Biden also suffers from this condition.

Emerging in recent yearsPulsed Electric Field AblationCompared to traditional cryoablation and radiofrequency ablation,Better safety and effectiveness, many large device manufacturers are conducting research and development. Currently, Johnson & Johnson'sVARIPULSE SystemRanked third on the commercialization path, received approval from Japan in January,Second only to Boston Scientific and Medtronic。

VARIPULSE System CurrentlyIt is Japan'sThe First and Only Pulsed Field Ablation Product, alsoThe world's first andThe Only OnePulse Field Ablation System Integrated with CARTO™ Mapping System,Components are as follows:

VARIPULSE™ Ablation Catheter：

Continuing Johnson & Johnson's LASSO catheter technology, with 10 electrodes on the circular tip;
The size of the circular tip can be adjusted, ranging from 25 to 35mm;
The catheter can be bidirectionally deflected (180° on one side and 90° on the other), suitable for all four pulmonary veins;
During ablation, the electrode voltage was 1800 V;
Using a bipolar configuration, applied between electrodes with adjacent spacing and directly adjacent electrodes;
The total application duration is approximately 250 milliseconds;

TRUPULSE™ Generator：

Multi-channel PFA Generator;

CARTO™ 3 System：

Simultaneously using magnetic and electric fields for mapping and locating intracardiac electrical signals;
Directly display intracardiac anatomical structures in three-dimensional form;
Using the global GPRS satellite positioning principle, the magnetic positioning sensor is embedded into the tip of the mapping and ablation catheter.

Dual-positioning technology ACL enhances the accuracy of cardiac mapping, enabling real-time precise visualization for all intracardiac catheters.
Rapid modeling during catheter movement to achieve synchronization of cardiac anatomy and electrocardiographic information;
Help the operator determine the origin of excitement, the presence and location of reentry circuits;

Adding endocardial voltage information, accurately displaying abnormal endocardial voltage areas, is beneficial for the treatment of scar-related ventricular tachycardia.
The image quality is comparable to 3D reconstruction of cardiac CT;
With powerful patient position compensation capabilities, it greatly reduces intracardiac electrical information errors caused by patient movement during surgery.

# inspIRE: For Europe and Canada

inspIRE Study (NCT04524364) is aFor drug-refractory paroxysmal atrial fibrillationA prospective, multicenter, single-arm study conducted from March 2021 to May 2022 across 13 institutions in Canada and Europe.

The study used the Varipulse system for pulmonary vein isolation, with 24-hour Holter monitoring at 3, 6, and 12 months; remote rhythm monitoring once a week from 3 to 5 months; and remote monitoring once a month from 6 to 12 months (in addition to monitoring, symptoms were also checked).

ResearchThe primary efficacy endpoint was acute pulmonary vein isolation and freedom from recurrent atrial arrhythmias (atrial fibrillation, atrial tachycardia, or atrial flutter) at 12 months.The final analysis of the study focused on the key phase (second wave) of the 186 patients who complied with the study protocol, with a follow-up period of 12 months.

The main data for 12 months is as follows:

The incidence of major adverse events was 0.0%.；
Among patients who received the most effective PFA treatment,AchievePrimary Efficacy EndpointThe probability is 80%.；
Achieve Primary Efficacy Endpoint, which means successful acute pulmonary vein isolation and no recurrence of atrial arrhythmias (atrial fibrillation, atrial tachycardia, or atrial flutter) within 12 months.The probability is 75.6%.；
The use of fluoroscopy was shorter (7.8 minutes), partly because the VARIPULSE system integrates with the CARTO 3 mapping system.

# admIRE: For the U.S. Market

The admIRE study is a prospective, multi-center, single-arm study aimed at demonstrating the use of the VARIPULSE system for pulmonary vein isolation to treat patients in the United States.Symptomatic Drug-Resistant Paroxysmal Atrial FibrillationThe safety and long-term effectiveness of the patient.

The study includes a pilot phase and a pivotal phase, with the former assessing the safety and efficacy of the device and the latter evaluating the VARIPULSE system against prespecified performance goals.

ExperimentalThe primary safety endpoints include the incidence of early (within seven days) major adverse events, atrial-esophageal fistula (within 90 days), cardiac tamponade or perforation (within 30 days), and pulmonary vein stenosis (within 12 months).In addition, the study also evaluated acute procedural success (defined as confirmation of entry block at the end of the procedure) and freedom from recurrent atrial arrhythmias at 12 months.

The main data for 12 months is as follows:

Among the 20 patients who completed the 12-month follow-up,The ablation procedure was successful in 100% of the patients., 80% of patients had no recurrence of atrial arrhythmia within one year.；
In the pilot phase of the study,No major adverse events related to surgery or equipment were reported.；
The median procedure time and fluoroscopy time for ablation procedures were 90.0 minutes and 3.5 minutes, respectively (mainly due to the integration of the CARTO 3 mapping system).

# About Biosense Webster

Biosense Webster is a company formed by Johnson & Johnson in 1996 after acquiring Cordis Webster for $1.8 billion and Biosense for $400 million.Specializing in Johnson & Johnson's electrophysiology businessAt the time, Cordis Webster's core products, catheters and angioplasty balloons, helped further enrich Johnson & Johnson's cardiac stent product line.Biosense, thenIs the world's first heartCompany of the Three-Dimensional Electrophysiological Mapping System, founded by Harvard University in 1993.

The company's products are divided into six categories:3D Navigation System, Diagnostic Catheters, Therapeutic Catheters, Ultrasound Equipment, Interventional Devices, Generators。

In May 2023, Johnson & Johnson's Biosense Webster announced the appointment of Jasmina Brooks as President.

In August 2023, Biosense Webster officially announced that multiple cardiac ablation products had been approved by the FDA for use without a fluoroscopic navigation system.

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