Johnson & Johnson Submits FDA Application for First PFA System Varipulse™, Backed by admIRE Trial Data

Mar 26, 2024 14:08 CST Updated 14:08

Johnson & Johnson

Medical Device R&D and Manufacturer

Source of the article:Heart NotCome;Editor: Sophia

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Heart Future

Recently,Biosense Webster, a subsidiary of Johnson & JohnsonAnnouncementSubmitted to the FDA, hoping thatFirst PFA Product——Varipulse Pulse Field Ablation (PFA)Can obtain pre-market approval。The submitted materials includeadmIRE Study Data。

Currently, Varipulse Pulse Field Ablation (PFA) has already beenEurope, JapanApproval obtained.

If this application is successful, Varipulse will becomeThe ThirdPFA System Authorized for the Treatment of Atrial Fibrillation (AFib)。

CurrentlyFDA has approved Medtronic's PulseSelect and Boston Scientific's FARAPULSE.，Varipulse Is very likely to become the third PFA product approved by the FDA.Based on the FDA approval progress of the first two products,Varipulse is expectedApproved by the FDA in the third quarter of this year。

Before Johnson & Johnson submitted the registration to the FDA,Varipulse Already approved for marketing by Japan's pharmaceutical regulatory authorities and CE. In Europe,Varipulse Will compete with PulseSelect and FARAPULSE in advance.

In the competition with PulseSelect and FARAPULSE,VaripulseWhether CARTO 3 can achieve a 1+1>2 effect remains to be seen.

# Varipulse™ Platform

Varipulse ByVaripulse Ablation Catheter andTruPulse Composed of generators and perfectly compatible with Carto 3.Varipulse is the first and only PFA technology integrated with Carto 3., realizing an intuitive and reproducible workflow through real-time visualization and feedback mechanisms.CArto 3 is also Johnson & Johnson's greatest advantage in the PFA field to defeat other competitors in the future.。

Varipulse™ The platform consists of multiple components, including:

Varipulse™ Catheter(Fully Integrated Variable Loop Multi-Electrode Catheter)
Varipulse Ablation Catheter isDeveloped based on Johnson & Johnson's previous mapping catheter, the Lasso catheter.
The ablation catheter has 10 electrodes on its adjustable circular tip, with a size range of 25 to 35mm.The catheter can be bidirectionally deflected, with one side deflecting 180° and the other side deflecting 90°.

TruPulse™ Generator
The TruPulse generator is a device used for cardiac ablation therapy.In the treatment of cardiac arrhythmiaProvide reliable power transmission and control, Accurate Ablation。
This generator is typically used in conjunction with other ablation devices and catheters forGenerate Pulse Fields Inside the Heart。

Carto™ 3 System（ChinaGlobally Leading 3D Cardiac Mapping System)
Carto 3 Utilizing advanced3D Imaging Technology, which can be used to perform real-time procedures on the patient's heart in the operating room.High-resolution mapping。
It can accuratelyLocating Abnormal Electrical Activity in the Heart, and provide doctors with visual navigation and positioning information to guide cardiac ablation treatment.

# admIRE Study Data

The materials submitted by Biosense Webster this time includeadmIRE Study Data。

admIRE(Evaluation of Varipulse for the treatment of drug-refractory paroxysmal atrial fibrillationSafety and Effectiveness, Study location: United States)

The results are as follows：

100%The patients achieved acute success through ablation;
80%Patients did not experience recurrence of atrial arrhythmia within one year;
Main issues related to surgery or instrumentsAdverse Event Reports: 0;
The median operation time and fluoroscopy time were respectively90.0 minutes and 3.5 minutes.

# Executive Evaluation

President of Biosense WebsterJasmina Brooks Evaluation:

"Varipulse Because of ItsCarto 3 Integration and Mapping FunctionalityWhat sets it apart is that Biosense Webster is developing a multifunctional PFA tool suite as part of its effort to meet the diverse needs of doctors and patients.Based on the results of the admIRE clinical trial, we believe that this innovative technology has the potential to deliver significant value and differentiation, and become an important tool in the treatment of atrial fibrillation.”

About Biosense WebsterCompany

Biosense Webster isJohnson & JohnsonIn 1996, respectively, for 1.8 billion US dollars and 400 million US dollarsMerger after the acquisition of Cordis Webster and BiosenseThe company, which has since arrived, is currently solely responsible.Johnson & Johnson's electrophysiology business is dedicated to researching and developing electrophysiological interventional diagnosis and treatment products.

Biosense is a world leader in 3D mapping systems and software with its superior and innovative technology. It is also the inventor of the world's first deflectable catheter.

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

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