Electrophysiology Heats Up: Abbott Enters the PFA Fray with Volt™ System and Files IPO Prospectus

Image | Shutterstock

Recently,Abbott Announces Latest Advances in Electrophysiology Pulsed Field Ablation (PFA).

Specifically include:Global IDE Registration for Volt™PFA System Completed Ahead of Schedule; Tactical Flex™Duo Ablation Catheter Sensor Enabled™ Undergoing Global FOCALFLEX Trial; Advisor™HD Grid X Mapping Catheter Sensor Enabled™ Receives FDA Approval and Begins Commercial Launch。

According to AbbottThe official website introduction states that the two types of catheters mentioned above are being developed as important tools for doctors to treat patients with abnormal heart rhythms such as atrial fibrillation (AFib). Among them, the mapping catheterWill further support the mapping of PFA and radiofrequency ablation cases, while cardiac anatomyThe visualization of the incision is crucial for patients undergoing ablation surgery to achieve the best outcomes.

It is reported that,MedtronicChina VOLT-AF IDE Study Enrollment Completed 4 Months Ahead of Schedule, enrolling nearly 400 patients in just three months.In addition, the FOCALFLEX pulsed field ablation study is currently underway and is expected to launch soon in the United States, with approximately 200 patients across 25 sites.

The rapid development of PFA has opened up a new battleground in electrophysiology. Research firm BTIG predicts,Within the next three years, half of the atrial fibrillation ablation procedures may switch to PFA.。Centering on this emerging market,The battle between the giants has reached a fever pitch.

July this year, Boston ScientificUnder its umbrellaFARAPULSE™ PFA SystemReceived NMPA innovative product approval, becoming the first PFA product to simultaneously obtain FDA, CE, and NMPA approvals. Boston Scientific's Q2 2024 earnings report shows,Thanks to the Farapulse system, the sales revenue of its electrophysiology business increased by 125% year-over-year.。

MedtronicPulesSelec has now received CE, FDA, Japanese regulatory, and NMPA approvals.NewClinical study results show that,The system has a high rate of persistent lesion formation.。Invasive reconstruction performed approximately two months post-operation showed,PulseSelect PFA System Achieved Durable Isolation in 98% of Pulmonary Veins (PV) and 96% of Patients。

Johnson & JohnsonPFA Product Omnypulse recently completed clinical study enrollment. Previously, its Varipulse pulsed field ablation (PFA) received CE approval for marketing, making it the third company, after Medtronic and Boston Scientific, to have a PFA product approved with the CE mark.

The consecutive entry of giants has brought uncertainty to the existing PFA market landscape. The highly competitive track, filled with strong players, demands higher levels of product innovation and effectiveness, significantly increasing pressure on domestically produced brands that started later.

According to Frost & Sullivan's forecast, the market size of PFA 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 is also expected to continue to rise.From 8.18% in 2025 to 38.87% in 2032.

Among the aforementioned giants, Boston Scientific and Medtronic have officially entered the domestic market in China, exerting strong competitive pressure on local players with their technological advantages and brand value. As of now, two China-based companies have received approval for their PFA products to be marketed, respectively.Jinjiang Electronics and Denovo Electrophysiology. In addition,Huitai Medical, Micro EP, Maiwei MedicalAnd many others alsoEntered the clinical enrollment phase.

Although the competitors are powerful, local brands also have objective advantages in the domestic market, including faster approval speeds. For example2023Year12Month, Jinjiang ElectronicsLEAD-PFACardiac Pulsed Field Ablation System andPulsedFA OnceSexObtained using a cardiac pulsed field ablation catheterNMPAMarketing Approval,It took less than1Year Time。

Guolian Securities Research Report mentioned,As more manufacturers complete their clinical trials one after another,Multiple Chinese brands enter special review process, expected toPFAOvertaking on the curve in the field, breaking the monopoly of imported products in 3DThe long-standing monopoly in the electrophysiology ablation field.

In addition,WithThe gradual implementation of the electrophysiology centralized procurement policy has increased the usage rate of domestically produced mapping and ablation catheters in China.PFADomestic companies with faster layouts are expected to gain a leading advantage in the next round of centralized procurement, prioritizing the expansion of more...Hospital Channel.

According to the Frost & Sullivan report,2021In China, the volume of cardiac electrophysiology procedures reached21Ten thousand cases,2017-2021YearCAGR For11.60%。With the aggravation of population aging, the number of patients is increasing, and medical treatment conditions...As the situation gradually becomes more convenient, the number of surgeries continues to grow.Expected2025Will reach by the year5710,000 cases, duringCAGRFor28.00%。

From the perspective of existing medical resources in China, the application of PFA in China will still require a relatively long period of time. The interim transition period can provide some growth time for domestically produced PFA, allowing for identifying gaps and making improvements while products from Boston Scientific, Medtronic, and others are in use. This can help find new clinical pain points to enhance competitiveness.

According to the 2022 research data from The Lancet's subsidiary journal,It is estimated that there are currently 20 million people with atrial fibrillation in China, and by 2050, approximately 9 million elderly people over the age of 60 in China are expected to suffer from atrial fibrillation.。

Given such a vast potential market, it is unlikely that a winner-takes-all scenario will emerge in China's PFA sector. Domestic brands that currently focus on refining their technology and cost-performance ratio still have room to break through, and the ultimate market winner remains uncertain.

- END -

Author: Yuezhi Qing

WeChat ID: zcxujingmin

Editor: Qin Jiu

WeChat ID: nrzx0321