Race to Lead the Atrial Fibrillation Market: Johnson & Johnson, Medtronic, and Boston Scientific in Pulse Field Ablation Showdown

Jan 11, 2024 19:10 CST Updated 19:10

Johnson & Johnson

Medical Device R&D and Manufacturer

Medtronic

Medical Device Manufacturer

In the field of cardiac treatment technology innovation, competition is becoming increasingly fierce. Recently, Biosense Webster, a subsidiary of Johnson & Johnson Medical, announced that its Varipulse platform has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of atrial fibrillation (AFib). This isJapan's First and Only Approved Pulsed Field Ablation (PFA) System.

Varipulse Pulsed Field Ablation System

Image Source: Biosense Webster

Among the Strong, Who Can Take the Lead?

Previously, numerous companies worldwide have actively engaged in the development of innovative solutions. From Medtronic's first FDA approval for PFA in treating paroxysmal and persistent atrial fibrillation to Boston Scientific's recent announcement that its Farapulse PFA system is expected to receive FDA approval in the first quarter of 2024, these developments fully demonstrate the vibrancy and growth potential of the PFA technology market.

Medtronic:

Medtronic PulseSelect Pulse Field Ablation (PFA) System

Image Source: Medtronic

November 2023,Medtronic Announces CE Approval for Its PFA Product – PulseSelectThis is Medtronic's second PFA product to receive CE approval, following the approval of the Affera Mapping and Ablation System in March.

In just under a month, on December 13, 2023, Medtronic once again announced that it had received FDA approval, allowing its PFA product, PulseSelect, to be marketed for the treatment of paroxysmal and persistent atrial fibrillation (AF). This isThe first PFA product to receive FDA approval, the launch of PulseSelect marks the entry of the atrial fibrillation ablation field into the PFA era., which is a milestone for the PFA market.

Medtronic stands out among many competitors to become the world's first PFA product approved by the FDA.A key factor lies in its outstanding IDE research data, far exceeding expectations.According to the IDE study data released by Medtronic at the beginning of the year, PulseSelect surpassed expected goals in both safety and efficacy (with a safety event rate of 0.7% for patients with paroxysmal and persistent AF, and a clinical success rate of 80%). With the FDA approval of PulseSelect, AF ablation therapy has officially entered the new era of PFA.

PulseSelect is an innovative atrial fibrillation (AF) treatment technology that utilizes pulsed electric fields for therapy and delivers bipolar, biphasic pulsed electric fields through a circular multi-electrode array catheter. The technology consists of five components, including a steerable multi-electrode circular ablation catheter, PFA generator, ECG-Gated, Tableside control, and a 10Fr bidirectional sheath.

PulseSelect's steerable multi-electrode circular ablation catheter features a proprietary biphasic waveform, a unique built-in guidewire, and a 20° forward tilt design, offering enhanced visibility, reliability, and safety during surgical procedures. According to Medtronic, using this technology for single-shot pulmonary vein isolation requires an average total energy delivery time of just 30 seconds to successfully isolate all veins. This isolation time and capability have been validated in the large-scale PULSED AF clinical study.

Boston Scientific:

Boston Scientific FARAPULSE Pulsed Field Ablation System
Image Source: Boston Scientific

On January 30, 2021, Farapulse, a Boston Scientific company, announced that its FARAPULSE Pulsed Field Ablation (PFA) product received CE approval for market release.Becoming the world's first PFA technology (used for atrial fibrillation ablation) to receive CE approval.

In December 2023, Boston Scientific initiated the AVANT GUARD clinical trial for the FARAPULSE Pulsed Field Ablation (PFA) system as a treatment for persistent atrial fibrillation. The first trial participant was enrolled at the Cleveland Clinic in the United States. Boston Scientific anticipates receiving FDA approval for the FARAPULSE PFA system in the first quarter of this year.

Boston Scientific's FARAPULSE PFA System received FDA Breakthrough Device Designation in 2019.

The FARAPULSE PFA System features a multi-level pulsed electric field ablation energy source with high tissue selectivity. It minimizes damage to adjacent tissues while enabling rapid energy delivery and the formation of continuous, transmural, and durable ablation lesions. Additionally, the design of the electric field parameters and electrodes is crucial for pulsed field ablation (PFA) products. The settings of pulse parameters, such as the number of pulse bursts, pulse duration, and interpulse intervals, significantly impact the safety and efficacy of PFA. The FARAPULSE PFA System uniquely adopts a spline-shaped catheter configuration, with each of its five splines equipped with four electrodes. When fully expanded, it forms a flat petal-like shape (with a distal diameter of 31 mm or 35 mm), and when partially expanded, it forms a three-dimensional basket-like structure. The basket diameter can be adjusted via catheter extension and retraction.

In China,Farapulse and PulseSelect have both entered the Innovative Green Channel., but Farapulse has already conducted real-world clinical research in Boao. In China, according to the current progress, Farapulse is expected to be faster than PulseSelect. However, recently, Sichuan Jinjiang Electronics or the National Medical Products Administration approved its "Single-Use Cardiac Pulsed Field Ablation Catheter" and "Pulsed Field Ablation System," which isThe First Approved Cardiac Pulsed Field Ablation Product in China。

PFA: Ablation Technology with Higher Safety

Pulsed Field Ablation (PFA) is a non-thermal method used for cardiac ablation therapy.。This method uses a microsecond-level high-voltage electric field,By using irreversible electroporation to destroy cardiac tissue. PFA is primarily used to treat atrial fibrillation (AFib), a common type of arrhythmia.

Atrial fibrillation is a type of heart disease in which the atria (the upper chambers of the heart) beat irregularly and usually at a faster rate. This can lead to reduced cardiac efficiency and may increase the risk of stroke. In PFA treatment, doctors use specialized catheters to ablate (destroy) the areas of heart tissue responsible for causing atrial fibrillation through an electric field generated by electrical currents. Compared with traditional thermal ablation techniques (such as radiofrequency ablation), the advantages of PFA lie in its minimal damage to surrounding tissues and its ability to take effect within a very short period of time.

A key advantage of PFA is its selectivity for cardiac tissue, avoiding damage to surrounding structures such as the esophagus and nerves. This makes PFA show great potential in terms of safety and effectiveness, although further research and clinical trials are still needed to determine its optimal application.

Biosense Webster's Varipulse platform not only stands out in a highly competitive market environment but also becomes a major highlight in the market with its unique performance and integrated solutions.

Early clinical research results from the inspIRE trial conducted in Europe show,The one-year clinical success rate using the VARIPULSE™ platform is as high as 78.9%.This success rate is defined as patients being free from documented symptomatic arrhythmia recurrence. In addition, the trial demonstrated excellent safety with no major adverse events reported (0%). The proprietary pulse sequence, catheter design, and CARTO™ 3 system integration of the VARIPULSE™ platform have streamlined workflow while achieving the shortest fluoroscopy time (7.8 minutes) and efficient procedure times (70 minutes).

Market Prospects: Expected Growth Rate of Over 20%

FMI data shows that 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. Based on historical data, the market has grown steadily with the adoption of modern technologies such as robotic-assisted surgeries and the reduction of invasive surgical techniques. As advancements in technology continue to enhance the efficacy, safety, and minimally invasive nature of this procedure, the market is expected to maintain its upward trend in the coming years.

Looking ahead,From 2023 to 2033, the global pulsed field ablation industry is expected to grow at a compound annual growth rate (CAGR) of 24.2%.As more electrophysiologists gain experience and adopt the technology, advanced evidence demonstrates the efficacy and safety of PFA, and with regulatory approvals from agencies such as the FDA for commercial use, the market is expected to grow at a rapid pace in the coming years.

In the field of pulsed field ablation, North America dominates, with the United States being the market leader. Thanks to the advanced healthcare infrastructure in the U.S. and the high awareness and adoption of cutting-edge medical technologies, there is a relatively higher incidence of cardiac arrhythmias, particularly atrial fibrillation, in this region, driving the widespread application of pulsed field ablation (PFA) in ablation procedures.

On the other hand,The Asia-Pacific region is considered a potential area for high growth in the pulsed field ablation market in the future.Particularly in China, with its rapidly developing healthcare industry, the rising incidence of cardiovascular diseases, and the trend of population aging, it has become a major highlight in this market.

According to data from Frost & Sullivan,China's pulsed electric field ablation consumables market is expected to grow to 10.99 billion yuan by 2030, based on 2023, with a compound annual growth rate of approximately 76.6%.However, the penetration rate of electrophysiology procedures in China is less than 1%, and the market share of domestically produced cardiac electrophysiology devices is also less than 10%. This indicates that the emerging field of pulsed field ablation for atrial fibrillation holds significant market potential.

Currently, in China's atrial fibrillation ablation market, radiofrequency ablation technology dominates, cryoablation has a relatively small share, and pulsed field ablation technology is still in its infancy. According to relevant data, in 2022, radiofrequency ablation accounted for 88% of atrial fibrillation ablation procedures in China, while cryoablation accounted for 12%. It is expected that within a short period, i.e., two years, pulsed field ablation will achieve commercialization in China. Looking ahead to 2028, the number of atrial fibrillation ablation procedures in China is expected to reach 590,000 cases, with pulsed field ablation potentially accounting for approximately 9%.

Source:

Frost & Sullivan

Review of Pulse Field Ablation Companies in China

Jinjiang Electronics

Recently, the National Medical Products Administration (NMPA) has prudently approved the registration applications for two innovative products from Sichuan Jinjiang Electronic Medical Technology Co., Ltd.: the "Single-Use Cardiac Pulsed Field Ablation Catheter" and the "Pulsed Field Ablation Generator." These newly approved products are China's first cardiac pulsed field ablation devices (Registration No. 20233012051). Notably, the solution submitted by Jinjiang Electronic integrates a 3D mapping system with PFA (Pulsed Field Ablation), starting with relatively advanced technology.

Maivis Medical

In August 2023, China's Maiwei Medical Company successfully completed all patient enrollments for the registration clinical trial of the world's first nanosecond pulsed electric field atrial fibrillation ablation (nsPFA) system. This system is currently the only nsPFA product globally to have entered the registration clinical trial phase.

Denovo EP

Denovo EP, established in 2016, is a subsidiary of Denovo Medical that focuses on comprehensive solutions for atrial fibrillation ablation and stroke prevention. It was the first to enter the PFA atrial fibrillation ablation market and has comprehensively laid out an overall treatment plan for arrhythmia. Its product, the CardioPulse™ Pulse Ablation System, is one of the first in China. It successfully completed clinical trial enrollment in January 2022 and was approved to enter the special review process for innovative medical devices in May 2022.

Xuanyu Medical

Xuanyu Medical was founded in 2020 as a high-tech medical device company specializing in electrophysiology and peripheral interventions. After years of research and technological breakthroughs, the company has developed innovative medical device solutions for diseases such as atrial fibrillation and varicose veins, aiming to become a leading provider of atrial fibrillation electrophysiology and peripheral vascular intervention solutions in China. The "multi-channel pulsed field ablation system," independently developed and produced by the company, completed its first clinical trial in March 2022, showing significant efficacy.

Xin Lü Tong

On January 7, 2023, the pulsed field ablation (PFA) system for atrial fibrillation treatment, independently developed by Shanghai Xinluitong Life Technology, successfully completed two registration clinical trials. This marks that Xinluitong Technology's PFA project has officially entered the registration clinical research enrollment phase.

Zhouling Medical

The LomaPulse® pulsed electric field ablation device, independently developed by Zhouling Medical, utilizes high-voltage electrical pulse energy capable of achieving selective myocardial ablation, effectively avoiding damage to normal tissues surrounding the lesion. At the same time, Zhouling Medical applies innovative catheter design technology, self-learning detection technology, and multi-modal polarization fusion ablation technology to the field of atrial fibrillation treatment, aiming to further improve the efficiency and success rate of ablation procedures.

Aikema

Founded in November 2020, the company has established nearly 10 product pipelines based on new technologies such as pulsed field ablation (PFA) and innovative three-dimensional mapping, covering the complete process of diagnosis and treatment for atrial fibrillation, premature ventricular contractions, and other arrhythmia ablations.

Huitai Medical

In February 2023, the innovative cardiac pulsed field ablation (PFA) system developed by China's Huitai Medical successfully completed the enrollment of all patients after undergoing pre-market clinical trials at multiple centers in China. This cardiac pulsed field ablation PFA system is the world’s first ablation system to integrate three unique functions: "contact force sensing/tissue proximity indication," "magnetic and electrical dual-positioning 3D mapping," and "pulsed field ablation."

Far Mountain Medical

Farpeak Medical's pulsed field ablation system can perform surgeries under local anesthesia, truly achieving non-thermal ablation, thereby significantly enhancing the safety and effectiveness of atrial fibrillation ablation procedures. In 2022, this system was granted special approval under China's Innovative Medical Device Program.

▲ Source: Medical Device Innovation Network

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