Johnson & Johnson's Biosense Webster Advances Dual-Energy Ablation Catheter Amid Rapidly Expanding Global PFA Market

Dec 15, 2023 18:05 CST Updated 18:05

Johnson & Johnson

Medical Device R&D and Manufacturer

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

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Heart Future

On December 14, 2023, Biosense Webster, a Johnson & Johnson subsidiary focused on electrophysiology, announced that the research on its dual-energy (radiofrequency + pulsed electric field) ablation catheter has completed the first batch of patient cases.

# Johnson & Johnson: Look at me

Although the experiment had not been underway for long, Biosense Webster still chose to make a move the day after Medtronic announced that its PulseSelect pulsed field ablation (PFA) system had become the first PFA system to receive FDA approval, showcasing its presence.

Boston Scientific previously estimatedPFA Will Dominate the Atrial Fibrillation Treatment Market in the Next Five Years, the FARAPULSE pulsed field ablation system under its subsidiary is also expected to receive FDA approval in 2024 (if the review period is 8 months, it will be approved in early 2024). Although Johnson & Johnson's pace is slower compared to Medtronic and Boston Scientific, this area still holds significant attention.Worth $9 billion, with a penetration rate of only about 5%, the PFA fat that is still growing at a double-digit rate naturally remains highly appealing.

# PFA Market Musings

What the future holds for the PFA market remains unknown, but analysts have made assumptions. One analyst conducted a survey of 25 U.S. electrophysiologists and interventional cardiologists to understand how they would adopt PFA technology.

She asked these experts to assume that Medtronic's PulseSelect and Boston Scientific's FARAPULSE receive FDA approval on January 1, 2024, while Johnson & Johnson's Varipulse receives FDA approval in January 2025. In this scenario, she projected that FARAPULSE would capture 14% of the market share, and PulseSelect would secure 9% of the market share in the year following FDA approval of FARAPULSE and PulseSelect. Meanwhile, the overall market share for radiofrequency ablation is expected to drop by 18 percentage points, while cryoablation would decline by 2 percentage points.

PulseSelect PFA System (Left) and FARAPULSE PFA System (Right)

Interestingly, nearly half of the doctors hope to increase the overall number of surgeries while increasing the use of PFA in the first year of its availability. After the FDA approves Johnson & Johnson's Varipulse and Medtronic's Sphere-9 system, Varipulse is expected to gain 10 percentage points of market share, Sphere-9 will capture 4 percentage points, and FARAPULSE will secure 16 percentage points.

VARIPULSE® Catheter (Left)

Analysts also indicated that in the third year after the initial official launch of PFA, traditional ablation methods would account for approximately half of the market share (42% radiofrequency ablation, 10% cryoablation), while PFA would occupy the remaining half (FARAPULSE accounts for 16%, Varipulse accounts for 13%, PulseSelect accounts for 10%, and Sphere-9 accounts for 7%."). In short, there is more than one winner, and the PFA market will be divided among the strong."

Affera™ Mapping and Ablation System

# Experiment Review

Johnson & Johnson's experiment on this dual-energy catheter is calledSmartPulse, is a prospective, single-arm, multi-center, clinical evaluation trial that will enroll approximately 250 patients with paroxysmal atrial fibrillation in the United States, studying dual-energyTHERMOCOOL SMARTTOUCH™ SF CatheterThe safety and effectiveness. The first cases were handled by Dr. David Newton, a clinical cardiac electrophysiologist at Memorial Health University, and Dr. Andrea Natale, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center.

THERMOCOOL SMARTTOUCH™ SF Catheter

The equipment included in the studyDual-Energy THERMOCOOL SMARTTOUCH™ SF Catheter(A type of focal contact force sensing catheter) andTRUPULSE™ Generator(Providing RF energy and PFA energy for the catheter). The catheter and generator areCARTO™ 3 Mapping SystemIntegrated together to provide staff with precise 3D visualization, allowing doctors to minimize reliance on fluoroscopy. Additionally, the workstation can provide parameters such as contact force index and ablation index for RF and PFA.

Carto® 3 System

The THERMOCOOL SMARTTOUCH™ SF catheter is characterized by its dual-energy capability, allowing for switching between radiofrequency and pulsed field energy to customize treatment. This single-catheter, dual-energy design streamlines the workflow of ablation procedures.

In addition to this experiment, Biosense Webster has another experiment calledSmartfIRE, completed enrollment in July this year. This study evaluates the safety and effectiveness of the dual-energy THERMOCOOL SMARTTOUCH™ SF catheter in treating drug-refractory atrial fibrillation in Europe.

# 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 that time, Cordis Webster's core products, catheters and angioplasty balloons, helped further enrich Johnson & Johnson's cardiac stent product line. Biosense, on the other hand, was the company that launched the world's first 3D cardiac electrophysiological mapping system, established by Harvard University in 1993.

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

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

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

Early December, Johnson & JohnsonJohnson & Johnson announced the completion of the acquisition of Laminar, a company focused on developing innovative technologies for left atrial appendage closure in non-valvular atrial fibrillation, for an upfront payment of $400 million (approximately 2.84 billion RMB), and will integrate Laminar into its operations.Biosense Webster，This shows that Johnson & Johnson has begun to focus on the electrophysiology field.

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