CIIE Spotlight: Johnson & Johnson, Medtronic, and Boston Scientific Showcase Next-Gen Atrial Fibrillation Ablation Technologies

Nov 07, 2023 00:01 CST Updated 00:01

Johnson & Johnson

Medical Device R&D and Manufacturer

Source: Siyu MedTech; Editor: Yang Liurong

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With the rapid growth of the patient population with atrial fibrillation (AF), the market demand for AF ablation technology has correspondingly expanded, and technological advancements have driven the diversification of treatment strategies. As a common and potentially harmful arrhythmia condition, AF increases the risk of thrombosis and cardiovascular diseases, particularly stroke and heart failure. Against this backdrop, ablation technologies—using radiofrequency ("fire"), cryoablation ("ice"), or pulsed electric fields ("electricity") to treat AF—have become an important treatment option due to their minimally invasive nature and efficacy.

According to "The Prevalence and Risk of Atrial Fibrillation in China: A National Cross-Sectional Epidemiological Study," the age-standardized prevalence rate of atrial fibrillation in China is 1.6%, with an estimated 20 million people affected. Based on the large patient population and the severity of the condition, cardiac electrophysiology procedures for treating arrhythmias such as atrial fibrillation in China have increased from 118,000 cases in 2015 to 212,000 cases in 2020.The market for cardiac electrophysiology devices in China is experiencing rapid expansion.According to data released by Frost & Sullivan, the market size of China's cardiac electrophysiology devices reached 5.15 billion yuan in 2020 and is expected to reach 21.11 billion yuan by 2024, with a compound annual growth rate of 28.3% from 2015 to 2020.Nevertheless,The penetration rate of electrophysiology procedures in China is still less than 1%, and the market share of domestically produced devices is less than 10%.

The high barriers to AF ablation technology are reflected not only in the professional requirements for doctors and technical complexity, but also in the R&D capabilities, clinical validation, and market recognition of related enterprises.Currently, China's atrial fibrillation ablation market is still dominated by foreign brands.SIYU MedTech takes you into the 2023 CIIE, let's take a lookJohnson & Johnson, Medtronic, and Boston ScientificThe latest developments of these few companies!

Johnson & Johnson

At this CIIE, Johnson & Johnson Medical Technologies unveiled nearly 30 products for the first time, among which the STSF DE Pulse/RF Dual-Energy Ablation Catheter made its global debut.

▲Figure: STSF DE Pulse/RF Dual-Energy Ablation Catheter

Mainstream catheter ablation typically uses heat (radiofrequency ablation) or cold (cryoablation) to interrupt irregular electrical pathways in the heart, thereby treating arrhythmias and atrial fibrillation. Pulsed field ablation is a new method for treating atrial fibrillation. It utilizes controlled electric fields to selectively ablate cardiac tissues that cause irregular heartbeats through a process known as irreversible electroporation. Since the energy does not rely on thermal effects to ablate the target cardiac tissue,Pulsed Electric Field Ablation TechnologyIt may reduce damage to surrounding tissues, including the esophagus, pulmonary veins, and phrenic nerve.According to Siyu MedTech,STSF DE Pulse/RF Dual Energy Ablation CatheterCapable of switching between radiofrequency and pulsed fields.

Johnson & JohnsonSTSF DE Pulse/RF Dual Energy Ablation CatheterWith contact force sensing capability, it is a steerable multi-electrode irrigated catheter. The TRUPULSE generator provides radiofrequency energy and a novel monopolar biphasic pulse sequence to this catheter by switching between two energy sources on the generator display.STSF DE Pulse/RF Dual Energy Ablation CatheterWill be used with the TRUPULSE generator for atrial fibrillation ablation, allowing pulse or radiofrequency energy to be delivered to the catheter tip electrode.

On March 7, 2023, Biosense Webster, a subsidiary of Johnson & Johnson, announced the use of its investigationalSTSF DE Pulse/RF Dual Energy Ablation CatheterThe first batch of cases has been conducted. This study will evaluate the system in standard electrophysiological mapping and ablation procedures for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation.

Medtronic

According to Siyu MedTech, MedtronicPulseSelectTMThe pulsed field ablation system is a representative work of cutting-edge ablation technology in the electrophysiology field. According to Siyu MedTech's understanding,Medtronic has proposed the first electrophysiology intelligent solution in China with three types of ablation energy —— "Cryo-Thermal-Electric" electrophysiology intelligent solution, featuring "Cryo-first, Diamond-constant-temperature, Stable-pulse-worry-free".

▲Figure: PulseSelectTM Pulsed Field Ablation System

Medtronic'sPulseSelectTMPulse Field Ablation SystemBipolar, biphasic pulse electric fields are delivered through a circular multi-electrode array catheter. In January 2020, the system received FDA approval for an Investigational Device Exemption (IDE) trial and was included in the list of special review results for innovative medical devices by the National Medical Products Administration (NMPA) in November 2020.

Boston Scientific

As the first medical device company in the world to offer a comprehensive solution integrating "ice," "fire," and "electricity" in the field of atrial fibrillation ablation, Boston Scientific showcased three products at the CIIE: cryoablation, radiofrequency ablation, and pulsed field ablation. Among them,FARAPULSE, the world's first pulsed field ablation system approved by the FDA, represents the latest cutting-edge product in Boston Scientific's comprehensive "ice," "fire," and "electricity" solutions. It will provide a "full-energy" solution for atrial fibrillation ablation in China, better meeting the diverse treatment needs of Chinese doctors and patients.。

▲Figure: FARAPULSE Pulsed Field Ablation System

Boston Scientific's product, the FARAPULSE Pulsed Field Ablation System, received the "Breakthrough Device Designation" from the U.S. FDA in 2019 and obtained EU CE certification in 2021. It is currently used for paroxysmal atrial fibrillation in Europe.

On March 12, 2023, the real-world study of the FARAPULSE system for the treatment of paroxysmal atrial fibrillation in the Chinese population was officially launched. Led by Professor Chen Minglong from Jiangsu Provincial People's Hospital, three "pilot" surgeries were successfully performed on patients with paroxysmal atrial fibrillation at Boao Super Hospital in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan. The successful enrollment into the real-world study signifies that the FARAPULSE PFA system has begun clinical data observation in the Chinese population, which is expected to accelerate its market approval process in China.

The development of atrial fibrillation ablation technology is of great significance for patients with atrial fibrillation.This technology can effectively restore normal heart rhythm by using catheters for positioning and ablation inside the heart.Different ablation technologies have their own advantages in surgical procedures, energy delivery, and catheter design, providing doctors with more options and personalized treatment plans.

While competition in technology drives innovation and progress, attention must also be paid to the safety and effectiveness of such technologies. As the industry advances technological development, it needs to strengthen regulation and collaboration to ensure that patients' interests remain the top priority.

The Competition and Cooperation in the AF Ablation Technology Market Coexist, Offering Patients More Treatment Options and Hope. With the Continuous Evolution of Technology, Siyu MedTech Has Reason to Believe That This Field Will Continue to Attract More Innovators and Investors, Bringing Better Treatment Outcomes and Quality of Life to AF Patients!

Editor-in-Chief | Zhao Qing Reviewed by | Yi He Typeset by | Yang Liurong