Medtronic Launches China's First Dual-Indication Pulsed Field Ablation System, Targeting a Billion-Dollar Atrial Fibrillation Market

Recently, the National Medical Products Administration announced the approval ofMedtronic's PulseSelect Cardiac Pulse Field Ablation (PFA) System Innovative Product Registration Application.The system consists of two innovative products: "Cardiac Pulse Field Ablation Instrument" and "Single-Use Cardiac Pulse Field Ablation Catheter."

As NMPA-approvedThe First ProductCan be applicable to bothParoxysmal Atrial Fibrillation, and is also applicable toPersistent Atrial FibrillationPFA products,PulseSelectThis entry into China will provide new treatment options for Chinese patients through breakthrough technology.

As we all know, as early as 2019,Boston ScientificJust as the United States launched the world's first pulsed field ablation (PFA) product——FARAPULS, and officially launched in China this July. In the race for NMPA approval in China, Medtronic was two months behind Boston Scientific but eventually caught up and received approval.

Thus, with the strong pursuit of the PulseSelect Cardiac Pulsed Field Ablation System,Will Medtronic surpass Boston Scientific to lead the PFA market in China?

To answer this question, we must first return to the market and the product itself.

Currently, the situation of atrial fibrillation prevention and treatment in China is severe. According to data, the number of patients with atrial fibrillation in China reached 20.2547 million in 2021, but there were only 100,800 atrial fibrillation ablation surgeries, with a surgery penetration rate of only 0.5%.

The reasons behind this, apart from patients' insufficient awareness of the disease, include the current clinical use of moreTechnical Drawbacks of Radiofrequency Ablation and CryoablationIs also an important factor for unmet clinical treatment needs.

Based on the significant pain points in the treatment needs and clinical applications of tens of millions of atrial fibrillation patients, Medtronic's PulseSelect Cardiac Pulsed Field Ablation System has achieved substantial breakthroughs in innovative technology and product design.

In addition to its groundbreaking technology and design, the superior clinical performance of PulseSelect will also add momentum to its commercialization process.

Last year, Medtronic announced that the PulseSelect Pulsed Field Ablation (PFA) system achieved its safety and effectiveness goals in the PulsedAF clinical trial, with results surpassing the anticipated safety performance targets:

According to Medtronic, the PulseSelect system has been launched and put into use in multiple regions including the United States, Europe, and Japan. More than 250 doctors globally have used the PulseSelect.Successfully Treated More Than 3,000 Patients。The approval and launch in China this time can further unleash the localized demand in the Chinese market.

The approval of PulseSelect this time not only ushers China's atrial fibrillation ablation into a brand-new era but also adds more momentum to the already red-hot field of cardiac electrophysiology in recent years.

It is reported that among global electrophysiology procedures, atrial fibrillation surgeries account for approximately 55% of the total, making it the largest single-disease market in the global electrophysiology surgery field. It can be said that,Whoever takes down the atrial fibrillation ablation market, takes down the entire electrophysiology market.

In the competition within the global market, Medtronic's primary rival is Boston Scientific. The rivalry between the two in the ablation sector is exceptionally intense. In terms of products, both companies possess the "ice, fire, and electricity" triad of energy elements, while in commercialization, Medtronic's market performance has consistently been...The Impact of Boston Scientific Products.

According toMedtronic's 2023 financial report shows that the net sales of Cardiac Rhythm and Heart Failure (CRHF) reached $5.835 billion, a 1% decrease compared to the previous year. One of the reasons for the decline wasCardiac Ablation Solutions Face Competitive Pressure in Western European Markets, and this pressure is most likely due to the early market launch of Boston Scientific's PFA product.

As the world's second-largest medical device market, China's centralized procurement policy has led to relatively moderate price reductions in the catheter ablation sector, which is beneficial for electrophysiology companies to expand their market presence. Therefore, after Boston Scientific's PFA product took the lead in the Chinese market in July, Medtronic, plc. naturally followed suit by aggressively entering the domestic PFA market with its own PulseSelec system.

Despite having just launched the first localized PFA product in China, Medtronic has long set its sights on this "fertile ground" of China's electrophysiology market:

First, in terms of strategic cooperationIn 2020, Medtronic, leveraging China's "Pilot Program" policy in Lecheng, signed a Strategic Cooperation Memorandum with the Boao Lecheng International Medical Tourism Pilot Zone Administration. The two parties established a comprehensive and in-depth strategic partnership in the fields of medical innovation and medical technology.

Then, in terms of technology introduction,Medtronic has successively introduced several revolutionary treatment solutions in the Chinese market, opening new avenues for clinical treatment in China's electrophysiology field.

Secondly, in the industrial ecosystem chain,To accelerate the advancement of its localization strategy and achieve over 80% localization of components in China, Medtronic has established production bases in Shanghai, Changzhou, Chengdu, and other locations, and set up a research and development center in China, committing to the R&D of localized products.

Finally, in terms of market education,Medtronic Innovation Centers were established in Shanghai and Chengdu, equipped with comprehensive simulation training facilities, including operating rooms, catheter labs, and more. These centers aim to provide clinical physicians with a more realistic surgical training experience and can train approximately 15,000 medical professionals annually.

It can be seen that Medtronic has a deep layout and planning in the Chinese market. By introducing innovative products, establishing innovation centers and manufacturing bases, as well as cooperating with the government, it has demonstrated itsStrategic Plan for Long-term Development in China。And with the debut of the first localized PFA product, Medtronic's localized strategic layout will enter a brand-new stage.

Currently, the Medtronic PulseSelec system has seen significant adoption and market success in Europe and the United States.

According to the financial performance of Medtronic's 4th quarter of the 2024 fiscal year, the total revenue of Medtronic's cardiovascular business was $11.831 billion.Reported growth of 2.7%, organic growth of 5.0%.And electrophysiology, as one of the细分领域 in the cardiovascular business, shows a steady growth trend, especially for cardiac ablation solutions in the international market.Showing a low double-digit growth trend.

The rapid data growth is directly related to the quick increase in sales of the PulseSelec system after receiving CE and FDA approval. This recent approval in China will undoubtedly accelerate its expansion in the Chinese market, further enhancing its market penetration and sales revenue. The pressure on Medtronic, which has been overshadowed by Boston Scientific in the global market, may be alleviated.

Looking back at the track itself,According to statistics, the market size of China's tumor ablation industry is expected to reach 6.15 billion yuan in 2023, while the electrophysiology industry is projected to exceed 12.32 billion yuan by 2023. The combined market size of both industries will reachNearly 20 billion。

WithMedtronic and Boston ScientificPFA products have been successively approved in the Chinese market, also allowingPFA Battle Extends from Overseas to China, and Chinese domestic enterprises will also be drawn into this鲶鱼 effect.

So inAgainst the backdrop of increasingly fertile soil for innovative medical devices in China,What kind of landscape will the PFA market present?

Currently, in China's cardiac electrophysiology (catheter ablation) market, foreign brands represented by Medtronic, Boston Scientific, and Johnson & Johnson occupy over 85% of the market share.Although domestic companies do not have an advantage in market share, their cutting-edge technology and competitiveness in the electrophysiology field are not weak.

Especially in the corePulsed Electric Field Ablation TechnologyAnd3D Mapping TechnologyAbove, several leading Chinese companies have taken the lead in laying out their strategies. In this revolution within the electrophysiology field, China-based enterprises have been closely following behind.

Before the international giants have fully entered the Chinese market,Jinjiang Electronics and Denovo ElectrophysiologyThe PFA product has been the first to receive NMPA approval for marketing, demonstrating the competitiveness of domestically produced products in China.

Among them,Jinjiang ElectronicsThe LEAD-PFA cardiac pulse field ablation instrument has made the fastest progress. As early as the end of 2020, the PFA ablation system was successfully developed, providing an integrated solution of 3D + PFA, and was approved for marketing last December.

Besides, there are at least in China currently50 EnterprisesIs currently developing a PFA cardiac ablation system.

Currently, two-dimensional mapping is still predominant in clinical practice in China. In the three-dimensional field, due to high technical barriers, domestically produced products have been promoted for only a relatively short period of time. Although over 90% of products in China come from...Johnson & Johnson, Abbott, butHuitai Medical, Micro EPThe three-dimensional mapping product has ranked among the top of domestically produced products.

Among them, MicroPort EP, as a listed company under MicroPort Medical that focuses on cardiac electrophysiology (catheter ablation) business, conducted a cumulative total of over 50,000 three-dimensional cardiac electrophysiology surgeries in 2023, marking an achievement inRanked first among Chinese manufacturers。

When the commercialization competition begins, whether it's overseas veteran giants or new forces enterprises in China, they must first withstand the test of the market if they want to occupy the market.

For overseas veteran enterprises,，Although the technology war has been won, in the Chinese market, due to factors such as production costs, policy-driven bulk procurement, and clinical differences among local patients, there will still be a long commercialization cycle for converting technological success into financial returns, along with market uncertainties.

For Chinese manufacturers,, The monopoly position of overseas giants in the past was largely due to the reliance of traditional atrial fibrillation ablation on three-dimensional mapping systems. However, the most widely used PFA products internationally do not completely depend on three-dimensional mapping systems. At the same time, domestically-produced three-dimensional technology has also made breakthroughs. Therefore, with the efforts of emerging companies, there is hope to break the current pattern.

Besides,Product Application ExpansionIt is also the direction for major companies to break through. For example, Medtronic's recent listingThe PulseSelect system, with its expanded clinical indications, is ahead of other PFA products produced in China, including those from Boston Scientific.

In the future, pulsed electric field ablation technology will inevitably develop towards more indications, and this might also be the key for enterprises to break through.

Medtronic Scientific - Cardiac Pulsed Field Ablation System

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