Johnson & Johnson, Medtronic, and Boston Scientific Compete in the Same Arena

In the electrophysiology market, competition among medical device giants has become extremely intense. As multiple new products have been successively approved, the battle for PFA, regarded as "the dominant cardiac ablation technology of the next decade," has intensified.

Recently, Biosense Webster, a subsidiary of Johnson & Johnson, announced its first PFA product——Varipulse Pulse Field Ablation (PFA) Receives CE Approval for Market LaunchThis means Johnson & Johnson is expected to become the third company, after Medtronic and Boston Scientific, to receive FDA approval for PFA technology to treat atrial fibrillation.

Pulsed Field Ablation (PFA) is a non-thermal method used for cardiac ablation therapy, whichUsing microsecond-level high-voltage electric fields to destroy cardiac tissue through irreversible electroporation. PFA is primarily used to treat atrial fibrillation, a common type of arrhythmia.

January 30, 2021Boston Scientific's Farapulse Announces CE Approval for FARAPULSE Pulsed Field Ablation (PFA) Product, Becoming the World’s First PFA Technology to Receive CE Approval

However, Medtronic caught up and took the lead,Just one month after announcing in November 2023 that its PFA product, PulseSelect, had received CE approval for market release, it successfully obtained the first FDA approval for PFA to treat paroxysmal and persistent atrial fibrillation, becoming the first pulse field ablation technology to gain FDA approval.

Immediately following, in January 2024, Boston Scientific officially announced,Farapulse's Pulse Field Ablation (PFA) System Receives FDA Approval

Kenneth Stein, Chief Medical Officer of Boston Scientific, said that this "rapid" approval was based on the strong performance and data of its clinical data. The Farapulse PFA System received CE certification in 2021 and has been used globally to treat more than 40,000 patients to date.

The弥漫战火 among giants shows the enormous market potential of PFA technology. Johnson & Johnson's official entry undoubtedly adds another flame to the future competition in the pulsed field ablation market.

The Market Potential of PFA is Emerging

Chinese Companies Actively Enter the Market

FMI data shows,From 2021 to 2022, the global pulsed field ablation market experienced a compound annual growth rate of 48.6%, reaching a market size of US$1.3 million by 2023.

Compared with radiofrequency ablation, PFA ablation has the characteristics of tissue selectivity and non-thermal ablation, which makes it safer for normal tissues. It also has many advantages such as low recurrence rate, fast speed, and short operation time. As the technology gradually matures, the proportion of PFA in the overall electrophysiology market size is expected to continue to rise.

For high-end medical devices, technological advantages are closely related to the commercialization process, but the patient population serves as a crucial cornerstone for market potential.

According to Frost & Sullivan's forecast, affected by the aging population,By 2025, the number of patients with tachyarrhythmia in China will reach 28.97 million, including 22.67 million atrial fibrillation patients, with 380,000 atrial fibrillation electrophysiology procedures expected to be performed, representing a procedure penetration rate of 1.7%.

With the increase in the number of patients and the improvement in technology penetration, the volume of surgeries is expected to maintain rapid growth, thereby driving the rapid expansion of the electrophysiology device market.It is expected to grow from 6.6 billion yuan in 2021 to 15.7 billion yuan in 2025, with a CAGR of 24%.

Compared with foreign giants, China-produced PFA started relatively late. However, under the considerable market potential, various related layouts have also begun to advance intensively, and some domestic companies have achieved preliminary results.

In December 2023, the National Medical Products Administration (NMPA) approved the innovative product registration application for LEAD-PFA Cardiac Pulse Field Ablation System and PulsedFA Single-Use Cardiac Pulse Field Ablation Catheter from Sichuan Jinjiang Electronics.The company's disposable cardiac pulsed field ablation catheter is the first pulsed field ablation product in China.

In August 2023, the world's first nanosecond pulsed electric field atrial fibrillation ablation (nsPFA) system developed by Maiwei Medical successfully completed all enrollments for the registration clinical trial.This system is currently the world's only nsPFA product to enter registered clinical trials.

In February 2023, APT Medical's innovative product, the cardiac pulse ablation PFA system, successfully completed the enrollment of all patients in the pre-market clinical trial conducted at multiple centers in China.This cardiac pulse ablation PFA system is the world's first ablation system that integrates three key features: "pressure sensing/contact indication," "magnetic and electrical dual-position 3D mapping," and "pulse ablation."

PFA is an emerging technology in the field of cardiac electrophysiology.，And relatedThe product is still in its infancy stage globally, and Chinese manufacturers are expected to achieve a leapfrogging advancement.