Medtronic's PulseSelect PFA System Gains NMPA Approval: A New Milestone in China's Cardiac Ablation Market

Sep 11, 2024 12:04 CST Updated 12:04

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source of the article: HeartFuture；Editor: Evan

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Heart to the Future

Recently, the National Medical Products Administration approvedMedtronic (NYSE: MDT) PFA Product ——PulseSelect SystemListed, the system consists of "Cardiac Pulsed Field Ablation System" and "Single-Use Cardiac Pulsed Field Ablation Catheter”TwoInnovative Product Composition. This is approved by the NMPAFirst ProductSuitable for both paroxysmal atrial fibrillation and persistent atrial fibrillation.PFA products.

The above two products are used together, utilizingPrinciple of Non-Thermal Effects of Pulsed Electric Fields, Treatment of drug-refractory, recurrent, symptomaticParoxysmal Atrial FibrillationOr drug-refractory, recurrent, symptomaticPersistent Atrial Fibrillation(Duration of episodes less than 1 year).Compared with traditional radiofrequency ablation and cryoablation products,The ProductCan achieve selective destruction of myocardial tissue,Avoid the risk of surrounding tissue damage caused by temperature transfer。

As of now, the NMPA has approvedFour PFA Products, these four products are respectivelyJinjiang ElectronicsPulsedFA,Denovo EPCardiPulse,Boston ScientificFARAPULSE andMedtronicPulseSelect.PulsedFA and PulseSelect areCircular Ablation Catheter, CardiPulse and FARAPULSE arePetal-shaped Ablation Catheter. Although domestic and international products seem to correspond with each other, they still have their own unique characteristics in design, which is why they can both enter the innovation channel.

# PulseSelect Pulsed Field Ablation System

Medtronic'sPulseSelect Pulsed Field Ablation SystemThe mapping and navigation system is from the acquisition in late August 2023 for nearly 1 billion US dollars.Affera Prism-1 Platform by Affera。

PulseSelect Pulsed Electric Field Ablation SystemIn 2018, it received the "Breakthrough Device Designation" from the U.S. FDA, and in January 2020, it received FDA's Investigational Device Exemption (IDE) for clinical trials.The First IDE Study on PFA。

In November 2023, the PulseSelect Pulsed Field Ablation System received CE approval;
In December 2023, it received FDA approval in the United States forTreatment of Paroxysmal and Persistent Atrial Fibrillation, becomingThe First FDA-Approved PFA System。
In May 2024, the PulseSelec pulsed field ablation system received regulatory approval in Japan, expanding the global reach of a proven safe and effective treatment technology for patients with paroxysmal and persistent atrial fibrillation (AFib).

Compared with the other three products listed in China, Medtronic's PulseSelect system...The biggest advantage is the wide range of indications.，The other three indications are all paroxysmal atrial fibrillation., persistent atrial fibrillation is still in clinical research.。

Product Features:

Plug and Play:PulseSelec Pulsed Field Ablation System is a plug-and-play system,Can be used with any mapping system., and can even be used directly in conjunction with X-ray fluoroscopy imaging.
Built-in Safety Features：Equipped with phrenic nerve test pulses, the voltage of these test pulses is very low and can be used before the formal ablation begins.Evaluate whether the ablation catheter is close to the phrenic nerve。
Nine electrodes with fixed spacing:Since the spacing between the nine electrodes at the catheter head is fixed after they form a disk shape,The generated electric field is consistent, allowing for continuous ablation.Moreover, these nine electrodes can also be used for pacing and sensing.
Small catheter diameter:The diameter of the ablation catheter is small, only 9Fr.(Encased in a sheath with a diameter of 10Fr), it facilitates easy access of the catheter to various anatomical structures.

# The Hidden King Who Surpasses Later

In the PFA field, Medtronic has risen to prominence and secured FDA approval for the world's first PFA product, outpacing all competitors.Boston Scientific, the pioneer in the field of ablation, was the earliest to obtain CE certification for PFA.In the global market, Medtronic and Boston Scientific have very strong competition in the ablation field.Products have gathered the three major energy elements of "ice, fire, and electricity."。

July 2024,Boston Scientific's FARAPULSE™ Series Pulsed Field Ablation Products, including FARAWAVE Single-Use Cardiac Pulsed Field Ablation Catheter, FARASTAR Cardiac Pulsed Field Ablation System,Approved by the National Medical Products Administration (NMPA). Thus far, Boston Scientific's FARAPULSE™ PFA System isThe world's onlyAt the same timeApproved for marketing by the EU CE, US FDA, and China NMPAThe PFA system.

Medtronic, plc. certainly did not want to be outdone. Two months later, it entered the PFA market in China with its own PulseSelect system.Although Medtronic entered the market later than Boston Scientific, it has also accumulated profound expertise in the ablation field.If Johnson & Johnson is considered the pioneer of radiofrequency ablation, thenMedtronic is the pioneer of cryoablation.. After allThe world's first cryoballoon ablation product, Arctic Front, came from CryoCath Technologies, which was acquired by Medtronic in 2008. Meanwhile, Medtronic also owns its own radiofrequency ablation system, DiamondTemp.

However, both radiofrequency and cryoablation technologies lack tissue selectivity and may cause damage to blood vessels, smooth muscles, the esophagus, nerves, and other structures around the heart, leading to surgical complications. According to predictions by American electrophysiologists, within the next year,The market share of radiofrequency ablation is expected to decrease from 68% to below 54%, while the market share of cryoablation will also drop from 23% to below 16%.. Meanwhile,The market share of pulsed ablation technology is expected to surge from 9% to 30%.。

This is also reflected in Medtronic's financial report. Compared with the fiscal year 2022, the net sales of Cardiac Rhythm and Heart Failure (CRHF) in fiscal year 2023 were $5.835 billion, a decrease of 1%. Medtronic stated in the financial report,One of the reasons for the decline is the competitive pressure faced by cardiac ablation solutions in the Western European market.. It is speculated that the "pressure in the Western European market" is most likely due toBoston Scientific's PFA Product Hits the Market First, With the approval of Medtronic's PFA product by the FDA, its market pressure may be alleviated.

On August 20, 2024, Medtronic announced its first-quarter financial report for the fiscal year 2025.Cardiac Ablation Solutions Business Achieves Mid-Single-Digit Growth Driven by the PulseSelect Pulsed Field Ablation System。

Since several PFA products have been approved for marketing in China, the first question these listed companies need to answer when participating in the commercial battle is:Why Choose Our PFA Products?

For Medtronic,The PFA catheter shape of the PulseSelect system is circular.Generally speaking, circular catheters, especially those with adjustable diameters, are relatively easy for intraoral ablation as their size can be adjusted according to the pulmonary vein diameter to complete the ablation; whereas fixed-curve circular catheters are more selective about pulmonary vein anatomy and can only adapt to certain pulmonary vein structures. During the vestibule ablation process,Whether it is an adjustable or fixed-diameter circular catheter, the limited ablation range makes it impossible to achieve one-shot., "segmental isolation" must be implemented for ablation, similar to the method of point-by-point radiofrequency ablation, and a three-dimensional mapping system is required to ensure continuous ablation, achieving complete coverage of the vestibule.

The reason why the PulseSelect system has gained prominence is not only due to its wide range of indications but also because of its excellent IDE study data., exceeding expectations. According to the IDE study data released by Medtronic at the beginning of the year:The safety incident rate was 0.7%, and the clinical success rate was 80%.The main and sub titles on the front page of the Medtronic PulseSelect product manual also feature"Setting New Standards for Safety", "Designed for Efficiency"Product Selling Points.

# Electrophysiology in China is Changing

The rise of PFA has rewritten the electrophysiology ablation market. As China's aging population continues to deepen, it also provides fertile ground for the rise of the PFA market. Amidst the two international giants not yet fully entering the Chinese market,Jinjiang Electronics and Denovo EP's PFA products have been the first to receive NMPA approval for marketing, demonstrating the competitiveness of Chinese manufacturers.。

Jinjiang Electronics, focusing on cardiac electrophysiology diagnostic devices, has raised a total of 700 million yuan in its Series A and B financing rounds. By the end of 2020, the company successfully developed the PFA ablation system, offering an integrated solution of 3D mapping + PFA.This system was approved for marketing by the NMPA on December 26, 2023.。
Denovo EP, a company under Denovo Medical that focuses on cardiac electrophysiology and the prevention and treatment of cardioembolic stroke,CardiPulse Pulsed Field Ablation SystemApproved for marketing on March 11, 2024, is the first basket/petal-shaped catheter approved for marketing by the NMPA in China.

The one-year follow-up results of the CardioPulse clinical study showed that a total of 143 patients with symptomatic drug-refractory paroxysmal atrial fibrillation were enrolled.HandThe immediate success rate of the surgery was 100%, and the success rate at 12 months was 86.7%, which is not inferior to similar products abroad.。

It can be seen that in this transformation of the electrophysiology field, Chinese-produced enterprises are also keeping up closely.

According to Frost & Sullivan's forecast,The market size of PFA in China will reach 1.3 billion yuan by 2025 and maintain rapid growth.Expected to reach 16.3 billion yuan by 2032, with a CAGR of 43.73%. The share of China's PFA market in the overall electrophysiology device market is also expected to continue rising.From 8.18% in 2025 to 38.87% in 2032。

China is the world's second-largest medical device market. As Boston Scientific and Medtronic's PFA products have successively entered China, the globally watched PFA battle has extended from overseas to within the country. Domestically produced enterprises will also be drawn into this鲶鱼 effect.In addition to companies that already have products on the market, there are also several promising players in China that have disclosed their latest developments in the PFA field.。

As of now,PFA from multiple companies such as HT Medical, MicroPort EP, and Maiwei MedicalThe product has entered the clinical enrollment phase.。From a global perspective, PFAAs an emerging technology, the gap between domestic and international accumulation is relatively small, and local brands are expected to rank among the top in future market competition.

February 2023,Huitai MedicalMedtronic's Cardiac Pulse Ablation System Completes Pre-Market Clinical Trial Enrollment, Its R&D projects also include pulsed ablation catheters, pulsed ablation systems, high-density mapping catheters, and pressure radiofrequency generators, etc.

Beixins LifeThe PFA product entered the innovation channel in January 2024 and is expected to be approved for marketing in 2025.The PFA system developed by the company adopts advanced high-density electrode design and nanosecond biphasic pulse technology. This technological innovation is expected to significantly improve the efficiency of ablation procedures and enable surgeries to be performed under local anesthesia.

And in June this year, it has just received 50 million in financing.Aikema Medical，It has established nearly 10 product pipelines, including pulsed field ablation and innovative 3D mapping, covering arrhythmias such as atrial fibrillation and premature ventricular contractions.The complete process of routine ablation diagnosis and treatment, in April last year,The AccuPulse Pulsed Field Ablation System, independently developed by the company, has completed all clinical study enrollments.。

According to incomplete statistics, more than 10 companies in China have already started to lay out in the pulsed field ablation sector, including others.Xuanyu Medical, Zhouling Medical, Hanyu Medical, Yuanshan Medical, Maiwei Medical, Xinlvtong, Xinhanglu Medicineetc.

Relevant industry insiders mentioned: "PFA is a revolutionary atrial fibrillation ablation technology. Compared with other atrial fibrillation ablation technologies, it is like electric vehicles replacing fuel vehicles, which requires a process.Currently, PFA in the field of cardiac electrophysiology is still in an early stage of development., products from Chinese manufacturers have not yet been widely used in clinical applications, and clinical data is still in the accumulation phase. However, as this technology continues to improve,After finding the optimal balance between the safety and efficacy of the product, is expected to gradually replace radiofrequency ablation and cryoablation, becoming the mainstream method for atrial fibrillation ablation.。”

At the same time, regarding the opportunities for manufacturers in China, it was further added: "In the past, Johnson & Johnson's monopolistic position was largely due to the reliance of traditional atrial fibrillation ablation on three-dimensional mapping systems, whereas existing...The most widely used PFA products internationally do not rely on a three-dimensional mapping system.(Boston Scientific Farapulse PFA), so with the efforts of emerging companies, there is hope to break the current pattern."

As the industry's emphasis on innovation continues to deepen,PFA is expected to gain dual sustainability in capital and policy.. As the clinical application of mature PFA products deepens in China, the penetration rate of related surgeries will also increase rapidly, laying the foundation for subsequent domestically produced brands to enter the market.The market competition between the established giants and the new forces has begun.。

# AboutMedtronic

Medtronic (Medtronic, NYSE: MDT) was founded in 1949 and is headquartered in Minneapolis, Minnesota, USA.Is a global leading medical technology company, with over 95,000 employees.

Medtronic's innovative solutions have expanded to more than 70 key disease areas, committed to providing lifelong treatment options for patients with chronic conditions. Every second, two patients worldwide benefit from Medtronic's medical technology or therapies.

Medtronic's main businesses includeCardiovascular, Medical Surgical, Neuroscience, and Diabetes BusinessesFour major parts, includingThe highest proportion is cardiovascular.。

On August 20, 2024, Medtronic announcedFirst Quarter Financial Report of Fiscal Year 2025, The financial report shows:

Revenue was $7.9 billion (approximately 56.32 billion RMB), with adjusted revenue at$80 Billion，Reported growth of 2.8%, organic growth of 5.3%；
GAAP net income was $1.042 billion, GAAP diluted earnings per share (EPS) was $0.80; non-GAAP diluted earnings per share was $1.23;

Among them, the cardiovascular product portfolio:Revenue of $3.07 billion, a year-over-year increase of 5.5%, with organic growth of 6.9%。

# Global Leading Cardiovascular Device Company

Medtronic｜J&J MedTech|Boston ScientificBoston Scientific|

Edwards Lifesciences | Abbott Abbott｜

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