Domestic PFA Innovators Challenge Global Giants in the World's Most Competitive Electrophysiology Market

Recently, several PFA products (Pulsed Field Ablation Systems), which are highly anticipated by the industry, have received approvals from regulatory bodies such as the U.S. FDA, EU CE, or China's NMPA, and will be accelerated for clinical use.

In 2024,How will PFA products, which are beginning to be commercialized on a large scale, change the complex and unpredictable electrophysiology market?Will it rapidly expand and disrupt the market, grow steadily and make progress step by step, or remain obscure and be abandoned by the market?

At the same time,How will the approval of multiple重磅 PFA products in major medical device markets such as the United States, the European Union, and China change the existing electrophysiology market landscape?In the case that PFA products stand out, will the future market pattern be divided among Medtronic, Boston Scientific, Johnson & Johnson, and Abbott? Or will domestic manufacturers such as Jinjiang Electronics, Ruidi Biotech, Aikema Pulse, and Beixins Life emerge as黑马s to dominate the market? Or will multinational giants coexist with Chinese manufacturers in the market?

In additionIn the case where giants like Medtronic, Abbott, Boston Scientific, and Johnson & Johnson have advantages in funding, branding, and channels, how should Chinese PFA manufacturers win this market battle?

In response to the aforementioned issues, VCBeat conducted in-depth interviews with multiple PFA manufacturers in China, hoping to gain a glimpse into the future.

In recent months, the PFA products of multinational device giants such as Medtronic, Boston Scientific, and Johnson & Johnson have been successively approved in major markets like the United States and the European Union.

In the U.S. market, Medtronic announced on December 13, 2023: its key PFA product, the PulseSelect Pulsed Field Ablation (PFA) System, received FDA approval for the treatment of paroxysmal and persistent atrial fibrillation, becomingThe World's First PFA System to Receive FDA Approval。

Following closely, Boston Scientific also announced in January 2024 that its Farapulse Pulse Field Ablation (PFA) System received FDA approval for pulmonary vein isolation in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF).The Second FDA-Approved PFA Product Globally。

In the European market, Boston Scientific's Farapulse pulsed field ablation system received EU CE approval as early as January 2021, becomingThe world's first PFA product to receive CE approval.In November 2023, Medtronic's PulseSelect Pulsed Field Ablation System received CE approval, becomingThe World's Second PFA System to Receive CE Certification。

Medtronic and Boston Scientific are fiercely competing in the U.S. and European markets, each striving to outpace the other. However, neither dares nor can afford to overlook Johnson & Johnson, which truly dominates the global electrophysiology market. Sure enough, on the last day of February 2024, Johnson & Johnson brought a surprise to the global PFA industry: its Varipulse pulsed field ablation system received CE approval, becoming...The Third CE-Certified PFA Product。

It is reported that the Varipulse Pulse Field Ablation System is used to treat symptomatic drug-refractory recurrent paroxysmal atrial fibrillation. Previously, the product received approval from Japan's MHLW in January 2024, becoming the first PFA product to be launched in Japan. Based on the progress of the Varipulse Pulse Field Ablation System, industry insiders expect that Johnson & Johnson's Varipulse is likely to become the third PFA product to receive FDA approval.

Moreover, another global device giant, Abbott, has also shown a strong interest in PFA technology. In January 2024,Abbott Announces Initiation of Clinical Trial for Its New Volt Pulsed Field Ablation System to Obtain EU CE Mark CertificationAbbott also expects the IDE clinical trial application for the Volt pulsed field ablation system to be approved by the FDA in the first half of this year.

As Medtronic, Johnson & Johnson, Boston Scientific, Abbott and other multinational giants' PFA products have been approved or are accelerating registration in major device markets such as the United States and Europe,It is expected that the four major device giants will engage in fierce competition in the global electrophysiology market to capture market share.。

It should be noted that,PFA is considered a disruptive innovation technology in the market., whose large-scale application may cause traditional products such as radiofrequency ablation, cryoablation, and 3D mapping systems to shrink in market size and reduce revenue. Currently, major electrophysiology companies like Medtronic and Johnson & Johnson generate most of their revenue in the electrophysiology field from traditional products such as radiofrequency ablation and 3D mapping systems. Therefore,How to balance corporate revenue, market competition, and the promotion of PFA will become a critical issue for industry giants.。

Unlike giants such as Abbott, Boston Scientific, and Medtronic, in the view of domestic companies,After the PFA product is approved, it will surely open up the market quickly and win market favor.。

For example,NorthX Bio believes that after the PFA product is approved, it will quickly enter the market, and given time, it can largely replace radiofrequency and cryoablation to become the mainstream electrophysiological ablation method."It is a revolutionary atrial fibrillation ablation technology. Just like electric vehicles replacing fuel vehicles, it will take a process for PFA to replace other atrial fibrillation ablation technologies. At present, PFA is still in an early stage of development in the field of cardiac electrophysiology, and domestically produced products have not yet been widely used in large-scale clinical applications. However, with the continuous improvement of this technology,After achieving the optimal balance between the safety and efficacy of the product, it is expected to gradually replace radiofrequency ablation and cryoablation, becoming the mainstream atrial fibrillation ablation method.”

From a clinical perspective, numerous published papers have demonstrated that PFA is a more efficient and safer method for treating atrial fibrillation.。Ruide BioIntroduced: A randomized controlled trial published in October 2023, titled "Comparison of the Efficacy and Safety of Pulsed Field Ablation (PFA) Technology with Radiofrequency Catheter and Cryoballoon Ablation for the Treatment of Paroxysmal Atrial Fibrillation," showed the following results:Despite the vast majority of physicians having only thermal ablation experience, PFA system outcomes were non-inferior to standard ablation, achieving both primary effectiveness and primary safety endpoints.。

During the 12-month follow-up, the treatment success rate without oral antiarrhythmic medication after a single procedure was 73.3% in the PFA group and 71.3% in the thermal ablation group. The degree of pulmonary vein stenosis at 3 months post-ablation was 0.9% in the PFA group, significantly lower than 12% in the thermal ablation group. The ablation time in the PFA group was 29.2 ± 14.3 minutes, significantly shorter than 50.0 ± 24.6 minutes in the thermal ablation group, with lower variability. Additionally, the adverse event rate was lower in the PFA group, at only 2.1%.

At the same time,PFA has advantages over traditional radiofrequency ablation and cryoablation technologies, such as tissue selectivity and non-thermal ablation.In surgical treatment, PFA does not cause damage to adjacent myocardial nerves, blood vessels, smooth muscles, etc.PFA also has the advantages of lower operational difficulty, ease of use, high ablation efficiency, and time savings., which is not only easy for doctors to use, but also improves treatment efficiency.

AikemaAlso believes:As multiple PFA products have been successively approved, PFA technology will be rapidly applied on a large scale worldwide and capture a significant share of the market for catheter ablation in atrial fibrillation. It is estimated that within the next five years, PFA will account for 30-50% of the global electrophysiology market share.。

In addition to the clinically agreed advantages, therapeutic benefits, and operational superiority, Aicomei also highlighted the health economics advantages of PFA. It stated, "The Farapulse PFA system, as a standalone PFA product without the support of a compatible 3D mapping system, achieved 12,000 procedures in Europe in its second year of approval." To date, the Farapulse PFA system has treated over 40,000 patients worldwide.PFA's independence from 3D mapping systems will reduce medical insurance and patient expenses, lowering the overall cost of atrial fibrillation treatment.。

In addition, the relentless development of PFA products by Johnson & Johnson, Abbott, and others will intensify competition in the PFA market, leading Medtronic, Boston Scientific, and other multinational giants to reduce their focus on traditional electrophysiology devices and increase efforts to promote PFA. After all,PFA is considered the next-generation ablation technology. Whoever captures the high ground of this market will have a significant advantage in the electrophysiology market over the next decade.Driven by giants such as Medtronic, Boston Scientific, Johnson & Johnson, and Abbott, the PFA market is expected to grow rapidly.

Outside the U.S. and European markets, China, as the world's second-largest medical device market, is also a key focus for major PFA companies. As of now, the PFA products from Medtronic, Johnson & Johnson, and Boston Scientific have all entered the NMPA Innovative Medical Device Special Review Process. However, Chinese companiesJinjiang Electronics' cardiac pulse electric field ablation system is the world's first PFA product approved by the National Medical Products Administration.。

In December 2023, the pulsed field ablation system independently developed by Jinjiang Electronics received approval from the National Medical Products Administration for marketing, intended for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. It is reported that its pulsed field ablation system consists of two parts: the LEAD-PFA Cardiac Pulsed Field Ablation Generator and a single-use cardiac pulsed field ablation catheter.

At the same time, the petal-shaped cardiac pulse field ablation catheter CardiPulse independently developed by Denuo Electrophysiology was approved for marketing by the NMPA on March 8, 2024, becoming the second cardiac pulse field ablation system to be approved by the NMPA.

In addition to Jinjiang Electronics and Deno EP, the progress of other PFA products made in China has also been extremely rapid. For instance, the PFSA system developed by ZHOU Ling Medical completed the world's first two surgical pulse field ablation procedures for atrial fibrillation in February 2023; the pulsed field ablation system from Xin Lvtong completed two clinical trial surgeries in January 2023.

In addition, the PFA products of domestic innovative companies such as NorthX Life, RuiDi Bio, AicoPulse, XuanYu Medical, MaiWei Medical, HongTong Industry, EpMed (a subsidiary of HuiTai Medical), and ShangYang Medical (a subsidiary of MicroPort EP) have entered the NMPA special review process. Approximately 50 other companies are also intensifying their research and development efforts on PFA cardiac ablation systems.

It is expected that the nine domestically produced PFA products that have entered the green channel, along with the three PFA products from multinational giants, will soon be approved. At that time, there will be more than 12 PFA products competing in the Chinese market.

It can be seen that,The market in China is almost the most competitive market globally.。Facing multinational giants with advantages in funding, branding, and channels, do domestic companies have the confidence to wage a market battle? Beyond the domestic market, how should Chinese enterprises compete globally against Johnson & Johnson, Boston Scientific, and Medtronic?

Regarding this issue, AccuPulse, Ruidi Biotech, and Northcore Life all expressed their readiness to take up the challenge with full confidence.

First, PFA products from Chinese manufacturers will obtain NMPA approval earlier, securing a first-mover market advantage.PFA products from companies such as AccuPulse, Ruidi Biotech, and NorthX Life generally started clinical trials in China earlier than multinational giants. AccuPulse expects its PFA product to be approved in China 1-2 years ahead of similar products from Johnson & Johnson, Abbott, and Medtronic, securing a first-mover advantage.

Secondly, domestic manufacturers have cost and policy advantages.In terms of cost, the product development and production costs of domestic companies have obvious advantages over international counterparts. In terms of policy, the "Outline of the National Medical and Health Service System Plan" and the "Implementation Opinions on Fully Promoting the Comprehensive Reform of County-Level Public Hospitals" issued by the State Council clearly require...Gradually improve the configuration level of medical devices produced in ChinaIt is clear that the National Medical Products Administration (NMPA), the National Health Commission (NHC), and the National Healthcare Security Administration (NHSA) are responsible for promoting the localization of medical devices. Additionally, local governments in Fujian, Sichuan, Hubei, and other regions have also stipulated that domestically produced medical devices can be given priority in procurement during tendering processes.

Finally, PFA products independently developed by Chinese manufacturers have special advantages., and it can respond more quickly to domestic market demands in subsequent commercialization, making timely adjustments and optimizing products. For example, AccuPulse's PFA product has specially designed a more reasonable catheter loop diameter for the domestic patient population. Clinical trial results show that its safety is excellent, with long-term effectiveness exceeding 85%, surpassing the clinical outcomes published by multinational giants.

Ruide Bio as one of the earliest companies in China to develop high-voltage pulse ablation for tumors,With multiple global first-ever patented technologiesIts ablation host energy release is equipped with a feedback system, and the ablation depth can reach transmural levels while precisely controlling the range. The integrated design of its ablation electrode mapping and ablation functions features a flexible, variable-diameter ablation catheter, which not only achieves standard atrial fibrillation pulmonary vein electrical isolation but also completes atrial ganglion plexus ablation. Additionally, its PFA product offers advantages such as an open and versatile mapping system.

NorthX Life has conducted extensive modeling and analysis in the physical and fundamental aspects, pursuing the ultimate balance in electrode configuration and parameter design to create an exceptional PFA product. NorthX stated: "To develop the most user-friendly PFA product that best leverages tissue-specific ablation advantages in performance, it is necessary to highly customize electrode design and parameter settings, pushing the user experience to the extreme—just as iPhone has taken user interface and experience to the pinnacle."

It is reported that the PFA system from Beixing adopts a high-density electrode design and nanosecond biphasic pulse technology, which can significantly improve the efficiency of ablation procedures and enable surgery to be performed under local anesthesia. Its PFA ablation catheter, based on a highly stable coupled basket design, can smoothly reach and closely adhere to all target pulmonary veins, greatly shortening the learning curve. The catheter also features 16 electrodes, allowing for single pulmonary vein isolation with very few discharges, simplifying the surgical process and improving operational efficiency.

After numerous consensuses, the enterprises have divergent attitudes towards the 3D mapping system.

NorthX Life and Ruidi Bio believe that their PFA systems do not rely on 3D mapping systems. For instance, NorthX stated: from the perspective of international clinical application practices, Johnson & Johnson's previous monopoly was largely due to traditional atrial fibrillation ablation’s reliance on 3D mapping systems, whereasThe most widely used PFA product internationallyAndWithout relying on a three-dimensional mapping system。Therefore, with the efforts of emerging enterprises, it is expected to break the current market pattern.

Ruide Bio is a great example. Unlike Johnson & Johnson's closed-loop approach, Ruide Bio’s products are designed with an open-source research mindset and can perform pulmonary vein electrical isolation without relying on mapping systems, even under ICE or DSA. In response to the actual conditions of grassroots hospitals, the integrated mapping and ablation catheter can be used in conjunction with Ruide Bio's magnetic and electric positioning navigation system or connected to other open-source mapping systems.

Ruide Bio stated: "In addition to strengthening cooperation with top-tier hospitals and their surrounding areas, we will further optimize the layout of下沉 markets. Meanwhile, based on universal catheters and open-type equipment, we will collaborate with other companies' products to create a full-process solution based on disease."

AccuPulse, on the other hand, stands on the opposite side. It believes that the success of PFA requires better positioning and contact, both of which cannot be achieved without the guidance of a 3D mapping system. Moreover, pulsed ablation under 3D guidance will significantly reduce X-ray radiation exposure for electrophysiologists, lower the learning curve, and serve as a better alternative to radiofrequency ablation and cryoablation. Therefore, AccuPulse has proactively embarked on the synchronized development of a 3D mapping system and a pulsed ablation system.

It is reported that Jinjiang Electronics has simultaneously developed a three-dimensional mapping system and a pulsed ablation system, and it has become the first company in China to launch a three-dimensional PFA treatment solution. Additionally, Jianhu Medical has introduced a three-dimensional dielectric pulsed electric field integrated ablation system.

Two viewpoints, two paths— which one better meets market demands needs to be tested by the market itself. We will continue to pay attention.