Johnson & Johnson's First PFA System VARIPULSE Receives FDA Approval, Igniting U.S. Market 'Three-Kingdom' Battle

Nov 07, 2024 22:17 CST Updated 22:17

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Johnson & Johnson announces its first PFA ablation catheter---VARIPULSEApproved by the FDA for marketing, can be used to treat drug-refractory paroxysmal atrial fibrillation.

PI Evaluation

"We understand that with PFA technology, mapping integration is crucial for physicians to 'see' inside the heart and deliver pulsed field energy accurately. With today’s approval, physicians will be able to use the integrated mapping system CARTO for PFA procedures, enabling a single, multifunctional workflow that can reduce procedure time and deliver positive outcomes for patients."

---Luigi Di Biase Montefiore Hospital

"As the prevalence of atrial fibrillation continues to rise around the world, innovative solutions are crucial for expanding patient options and helping doctors treat atrial fibrillation effectively and efficiently. The VARIPULSE platform enables efficient procedures with excellent safety, allowing me to treat more patients and help them return to normal life."

---Andrea Natale Texas Cardiac Arrythmia Institute

Executive Evaluation

"With this approval, we are thrilled to bring the VARIPULSE platform to electrophysiologists and patients in the United States, where atrial fibrillation affects nearly 8 million people. As the only PFA platform specifically designed to seamlessly integrate with the CARTO 3 system, we believe that this highly anticipated platform will become a valuable tool for physicians to perform safe, effective, and efficient atrial fibrillation procedures, offering an intuitive, repeatable workflow that requires almost no fluoroscopy."

---Jasmina Brooks, President of Electrophysiology, Johnson & Johnson Medical Technologies

In this new era of PFA, although Johnson & Johnson is slightly behind Medtronic and Boston Scientific, it still relies on its strong technology and presence in the electrophysiology field.Settle down, believe that Johnson & Johnson can catch up and make up for the one-year lag. AsVARIPULSEThe listing marks the official entry of the electrophysiology field into an era of three-way competition. Medtronic, Johnson & Johnson, and Boston Scientific will engage in a non-violent battle to treat 8 million patients. It remains uncertain who will emerge as the winner.

Johnson & Johnson Catheter (VARIPULSE) Compared with Boston Scientific products, it does not have much advantage, but its core competitiveness lies inCARTO 3 and Johnson & Johnson'sICE. WhenVARIPULSE+CARTO 3+ICE will create a remarkable chemical reaction. It not only enables more effective electrophysiological ablation but also allows the entire procedure to be performed with minimal or no radiation exposure (which is highly appealing to doctors).

VARIPULSEThe efficacy of CARTO3 1+1 was demonstrated in the admIRE study:

The overall primary effectiveness success rate was 75%.

The peak primary effectiveness of participants receiving 73-96 P for PFA pulmonary vein isolation was 85%.

The overall incidence of major adverse events was2.9%

No deaths, atrioesophageal fistulas, coronary artery spasms, or renal failure events requiring hemodialysis related to hemolysis associated with the device or procedure were reported.

100% of patients achieved acute surgical success;98%Veins Achieve Isolation at First Attempt
The median procedure time for pulmonary vein isolation (PVI) alone was 81 minutes, for all procedures it was 90 minutes, and the fluoroscopy time was 7 minutes.

43% of patients can be discharged immediately after surgery.

25% of surgeries withoutFluorescence ExaminationPerformed under the integration of VARIPULSE and CARTO 3, with no impact on safety and effectiveness.

Although Johnson & Johnson has superior strength in mapping and intracavitary ultrasound compared to its competitors, Boston Scientific and Medtronic are actively working to bridge this gap. Recently, Boston Scientific acquired a mapping company (Cortex) to enhance its mapping capabilities. Medtronic made a similar acquisition years ago.Affera, and this year in the United StatesDunli Launches Triple-Function Catheter with Electropulse, Radiofrequency, and Mapping Capabilities Alongside 3D Mapping System in the U.S., Poised to Compete with Johnson & Johnson.

Facing fierce competition, Johnson & Johnson needs to continue its efforts to launch more innovative PFA ablation catheters to meet future challenges.

VARIPULSE

VARIPULSEConsisting of the VARIPULSE ablation catheter and TRUPULSE generator, and capable ofCompatible with Carto 3.VARIPULSEIs the first and only integratedCarto 3PFA technology enables an intuitive and reproducible workflow through real-time visualization and feedback mechanisms.Carto is Johnson & Johnson's greatest advantage in the PFA field to defeat other competitors in the future. Without3DStandardMeasurement System，The therapeutic effect of PFA is at least half as effective, while Johnson & Johnson possesses the most powerful and advanced technology globally.3DMarkMeasurement System。

VARIPULSEThe ablation catheter was developed after Johnson & Johnson's previous mapping catheter, the LASSO catheter.Continuation of LASSO Catheter Technology. This also demonstrates Johnson & Johnson's strength in the catheter fieldProfound Technical Reserve。

VARIPULSEThe ablation catheter has 10 electrodes on its adjustable circular tip (ranging from 25 to 35mm).VARIPULSEThe ablation catheter allows for bidirectional bending, with 180° on one side and 90° on the other, making it suitable for all four pulmonary veins, including the right inferior pulmonary vein. PFA is applied in a bipolar configuration between skipped electrodes (i.e., electrode 1 to electrode 3) as well as between each adjacent pair of electrodes (i.e., electrode 1-2 and 2-3), with an energy level of 1800 V. Each PFA application consists of a sequence of microsecond-long biphasic pulses across all three bipolar configurations, with a total application duration of approximately 250 milliseconds.

VARIPULSE Demonstration

Biosense Webster

Biosense Webster, a professional medical device company under Johnson & Johnson, is dedicated to the research and development of electrophysiology interventional diagnosis and treatment products, providing comprehensive solutions for arrhythmia diseases to physicians and patients. Biosense has established itself as a world leader in 3D mapping systems and software through its excellent and innovative technology.It is also the inventor of the world's first curved catheter.