Electrophysiology Frontier Heats Up: PFA Market Sees Fierce Global and Domestic Competition

Oct 31, 2024 18:59 CST Updated 18:59

Medtronic

Medical Device Manufacturer

Image | Shutterstock

Source | CPhI China Medical Devices

Writing | Yueqing

The new battleground in electrophysiology sees continuous conflict, as major giants face head-on competition once again.

Medtronic's Another PFA Approved

Recently, Medtronic announced,Its Affera Radiofrequency Ablation System and Sphere-9 Catheter have received FDA approval.

Affera RFThe ablation system is an integrated solution with high-resolution mapping and therapeutic functions. The Sphere-9 catheter delivers simultaneously.Radiofrequency and Electropulse EnergyCatheter used for ablation, which gives doctors the ability to customize treatment plans according to patient needs during the ablation process, improving the flexibility and safety of the procedure.

Medtronic's PulseSelect PFA System Received FDA Approval in December 2023Medtronic is now the first and only company with two PFA technologies for the treatment of atrial fibrillation patients.。

The rapid development of PFA has opened up a new battleground in electrophysiology, and the successive entry of giants has further elevated the competition to an entirely new dimension.

Almost at the same time, Boston Scientific officially announced,Its FARAWAVENAV cardiac pulsed field ablation (PFA) catheter with magnetic positioning mapping functionality has received FDA approval, and the new FARAVIEW software module has also obtained FDA 510(k) clearance.。

At present, Medtronic and Boston Scientific are temporarily in the leading position in the PFA track. This time, both parties have obtained approval for their key products, and the future market competition between the two will be more intense.

Needham analysts pointed out in a report released last week that the intensifying competition in PFA could pose a potential threat to Boston Scientific, and they believe it is inevitable for Boston Scientific to lose significant market share.

High efficiency is also one of the key features of this PFA melee.

BTIG AnalystIndicates,Medtronic in May or even earlierTime to submitThe application has been approved, which meansApproved for less than 6 months。Considering this point, inJohnson & Johnson expects the approval of Varipulse to come soon after submitting it to the FDA in March.。

AbbottAlso disclosed recently,Completion of Global IDE Enrollment for Its Volt™ PFA System Ahead of Schedule; The tacticalflex™Duo ablation catheter SensorEnabled™ is undergoing the global FOCALFLEX trial; The Advisor™HDGridX mapping catheter SensorEnabled™ has received approval from the U.S. Food and Drug Administration and has begun commercial release.

High-Growth Track "Clash of the Titans"

A New Battlefield Has Been Opened in China

The enormous commercial value is driving the giantsOne of the primary drivers of the aggressive expansion. According to BTIG forecasts,Within the next three years, half of atrial fibrillation ablation procedures may switch to PFA.。

Boston Scientific's 2024 Q2 financial report shows,Thanks to the Farapulse system, the sales of its electrophysiology business increased by 125% year-on-year.Medtronic CEO Geoffrey Martha also said at the Wells Fargo event in September,The impact of Affera system revenue growth will begin to be felt in fiscal year 2026.。

Practitioners in China also followed suit,Huitai Medical, Micro EP, Yuanshan Medical, Zhouling Medical, Hanyu Medical, Maiwei Medical, Beixing Medical, Xuanyu Medical, Shangyang Medical, Ruidi Biotech, etc.Companies have all entered the PFA track.

Among them, the third-generation nanosecond pulsed electric field ablation (nsPFA) atrial fibrillation treatment product of Maiwei Medical has completed the registration clinical trial. The PFA product from Beixin Medical had also entered the special review process of the innovation channel earlier.

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

Although Chinese companies entered the PFA market later than foreign ones, the overall gap in this emerging field is relatively small, and they have a certain advantage in the speed of product approvals.2December 2023Jinjiang Electronics LEAD-PFA Cardiac Pulse Field Ablation System and PulsedFA Single-Use Cardiac Pulse Field Ablation Catheter Obtain NMPA ApprovalApproval,It took less than one year from the completion of clinical trials to approval.。

According to the Frost & Sullivan report,In 2021, the number of cardiac electrophysiology procedures in China reached 210,000 cases., the CAGR from 2017 to 2021 was 11.60%. With the increasing degree of population aging, the continuous increase in the number of patients, and the gradual convenience of medical conditions, the volume of surgeries has achieved sustained growth.It is expected to reach 570,000 cases by 2025, with a CAGR of 28.00% during the period.。

The giants have obviously smelled the huge potential market behind,Boston Scientific and Medtronic have recently announced their entry into the Chinese market one after another, leaving less and less time for the growth of local brands. It is expected thatNext, multiple PFA products made in China will enter the final stage before market launch, and the battle for market share is about to erupt.

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