Boston Scientific's Groundbreaking PFA System Launches in China, Offering New Hope for 12 Million AFib Patients

Jul 08, 2024 18:10 CST Updated 18:10

Boston Scientific

Medical Device Manufacturer

As one of the few "逆势增长" highlights in the global electrophysiology medical device market, major cardiovascular device giants are focusing on atrial fibrillation pulse field ablation.（PFA）MarketThe competition has long entered a fever pitch.

On the one hand, the three energy revolutions in human development history—"fire and grass," "coal and steam engine," and "oil and internal combustion engine"—all demonstrate the power of "new energy." In the field of cardiac catheter ablation, pulsed field ablation, by utilizing high-voltage electrical pulses as a new type of ablation energy, exhibits superior tissue specificity and energy safety compared to traditional ablation methods, thus becomingThe Transformative Force in the Atrial Fibrillation Ablation Market. It can be said that whether or not a pulsed field ablation market exists directly impacts the establishment of an electrophysiology company's "cutting-edge" image.

On the other hand, from the product perspective, the pulsed field ablation products launched by major cardiovascular giants not only represent the battleground for each brand's top electrophysiology technologies but also serve as a crucial revenue growth driver for electrophysiology businesses.In the first quarter of 2024,Boston Scientific's electrophysiology division achieved 70% global sales growth, with an impressive 85% growth in the U.S. market, such an increase is attributed to the company'sFARAPULSE™ Pulsed Field Ablation (PFA) SystemThe first quarter is closely related to FDA approval.

Behind the dual value of "technological innovation" and "performance growth," the phrase "whoever masters PFA will dominate the market" has become an undisputed fact in the electrophysiology field.

Today (July 8), Boston Scientific announced FARAPULSE™PFA System Approved for Marketing in China, Becoming the World's Only Product to Simultaneously Obtain EU CE, U.S. Food and Drug Administration (FDA), and China National Medical Products Administration (NMPA) Approvals）PFA system approved for marketing.

▲FARAPULSE™PFA System

Looking back, Boston Scientific was not the first company to enter the field of catheter ablation for atrial fibrillation. However, with a long-term perspective and great determination, this cardiovascular giant has not only successfully launchedThe world's first commercially available PFA system (For AF ablation), alsoIs the first inForeign Giant Boston Scientific Corporation Launches PFA System in China.

"Overtaking on a Curve": Taking a Harder Path

Atrial fibrillation is a common type of arrhythmia disease,The harm is great, which can lead to stroke, aggravate myocardial ischemia, induce heart failure, and in severe cases, cause death or disability.. With the aggravation of population aging, the prevalence of atrial fibrillation increases year by year.

Catheter ablation is gradually becoming a first-line treatment for rhythm control in atrial fibrillation.。

Due to traditional catheter ablation (includingRadiofrequency Ablation, Cryoablation) There is a risk of serious surgical complications such as pulmonary vein stenosis, left atrial-esophageal fistula, and phrenic nerve injury. How to perform atrial fibrillation catheter ablation more safely and effectively remains one of the challenging issues in clinical practice.

But even today, the clinical application of atrial fibrillation ablation procedures still predominantly features radiofrequency ablation, with cryoablation playing a secondary role.

As a latecomer in the atrial fibrillation field, an easier or more clever choice might be to follow the path of least resistance or adopt a "copy-and-paste" approach, sticking with traditional radiofrequency ablation and cryoablation to secure short-term gains.

But Boston Scientific chose a more challenging path, mapping out an ambitious blueprint for itself — while actively pushing forward with radiofrequency ablation and cryoablation, it is also seeking breakthrough innovations to bring more benefits to patients.

In 2014, Boston ScientificInvest in Medical Innovation EnterprisesFARAPULSE, acquiring approximately 27% of its equity. This investment has drawn the attention of the electrophysiology industry toFARAPULSEThe focused pulsed electric field ablation technology.

After 2018, a large amount of clinical data proved that,Compared with traditional ablation, pulsed electric field ablation has many advantages such as higher surgical ablation efficiency and fewer energy-related complications.But looking back at 2014, this investment was clearly very forward-looking at the time.

In 2021, FARAPULSE™ Pulsed Field Ablation (PFA)System Receives CE Approval`, becoming the world's first PFA system approved for atrial fibrillation.`In the same year, Boston Scientific acquiredFARAPULSEAll remaining shares.

Born to address the pain points of traditional ablation, FARAPULSE™ presents three major advantages:Safe, Effective, Efficient.

In terms of safety, FARAPULSE™The PFA system performs selective ablation of cardiac tissue through pulsed electric fields.Reduce the risk of damage to adjacent tissues such as the esophagus. And FARAPULSE™The unique ablation catheter design of the PFA system also allows operators to flexibly adjust it into flower-like and basket shapes during the procedure, enabling the device to better adapt to the patient's pulmonary vein morphology, requiring onlyA Few SecondsCan achieve pulmonary vein isolation, with its optimized energy delivery mode.Help reduce possible complications from thermal ablation。
In terms of effectiveness, multiple clinical studies have shown that performing remapping 2-3 months after the first ablation for patients resulted in a 96% pulmonary vein isolation maintenance rate with the optimized pulse waveform and ablation dosage, demonstrating FARAPULSE's...™PFA System in Clinical ApplicationReliable and StableThe therapeutic effect.
From the perspective of efficiency, the ADVENT study demonstrated that FARAPULSE reduces ablation time.™Ablation time of the PFA system (29.2±14.3 minutes)Significantly lower thanThermal ablation group (50.0±24.6 minutes), helps the surgeon significantly reduce operation time.

WithFARAPULSE™ The listing and the completion of the acquisition,Boston Scientific has achieved a remarkable "overtaking on the curve" with its excellent strategic vision and ultimate pursuit of patient benefits.

"Two-way Rush":Significantly shortenUS-China "Time Difference"

As "the leading technology in cardiac ablation for the next decade," the pulsed field ablation market has tremendous growth potential.

FMI data shows that from 2021 to 2022, the global pulsed field ablation market had an annual compound growth rate as high as 48.6%, and by 2023 the market size reached 1.3 million US dollars.From 2023 to 2033, the global pulsed field ablation industry is expected to grow at a compound annual growth rate of 24.2%.

To maintain an edge in the rapidly growing PFA market, Boston Scientific needs to capitalize on key points of industrial upgrading, continuously expand into overseas markets, and enhance the brand's competitiveness. In this effort, competing for the world's top two medical markets—the U.S. and China—is particularly crucial.

January 2024,FARAPULSE™ PFA System Launched in the U.S.

July 2024,FARAPULSE™ PFA System Launched in China.

The listing times in the U.S. and China are less than half a year apart, which was unimaginable in the past.

"Significantly shorten the 'time difference' for cutting-edge innovative products to serve Chinese patients, allowing rapid access to innovation."Chinese Market,What Did Boston Scientific Do Right?

RetrospectFARAPULSE™The history of PFA system's market entry in China shows that,In recent years, Boston Scientific has continuously leveraged"Pilot first""Cross-border Healthcare Access in Hong Kong and Macao"Innovative access pathways, such as exploring FARAPULSE™PFA System Begins Clinical Application in China Ahead of Schedule.

These explorations have been highly fruitful. As early as December 2021, FARAPULSE™The PFA system has already been approved by the Center for Medical Device Evaluation of the National Medical Products Administration, and has entered the special review process for innovative medical devices (also known as the "Innovation Channel"); in February 2023 and September 2023,FARAPULSE™The PFA system has successively launched the "Pilot Program" in Boao Lecheng and the Greater Bay Area. In addition, Boston Scientific also initiatedFARAPULSE™Real-world study of the PFA system in Chinese patients with paroxysmal atrial fibrillation.

Of course, ultimately, the successful application of various expedited market entry policies is still due to FARAPULSE.™The disruptive innovation of the PFA system itself.

For example, a medical device product wants to enter"Innovation Channel" not only requires core patents and innovation, but also that the product’s main working principle/mechanism is a first in China, with fundamentally improved performance or safety compared to similar products, and that it is at an internationally leading level in technology. It also needs to meetWith significant clinical application value,The requirements for the completion of the product's preliminary research, the authenticity and control of the research process, and the integrity and traceability of the research data have been met.

As for FARAPULSE™The PFA system demonstrates excellent effectiveness, safety, and efficiency in atrial fibrillation ablation due to its innovative energy delivery method and catheter design. Additionally, it already has robust clinical data support based on its approval and use in the EU market.

It can be said that,FARAPULSE™The Rapid Launch of the PFA System in China is a Disruptive InnovationA Two-Way Journey: Products and Innovation Support PoliciesThis also marks that this innovative technology will cover China, a high-potential emerging market, leading the field of atrial fibrillation treatment in China to accelerate into the PFA era.

Absolute Advantage: Quality Inspection by 70,000 Patients”

From the end of last year to now, multiple PFA products have been approved for marketing globally, and the competition in pulsed field ablation is becoming increasingly fierce. Medtronic, Johnson & Johnson, Abbott, Boston Scientific, Jinjiang Electronics, and Denovo Electrophysiology are all strong competitors in this field.

Under intense competition, the advantages of Boston Scientific's FARAPULSE™ PFA System are very obvious.

As the world's first approved PFA system for the treatment of arrhythmias, FARAPULSE™ PFA SystemThe system stands out in terms of usage, having been used to treat more than 70,000 patients so far, making it the most widely used PFA system globally.

The FARAPULSE™ PFA System is also the most studied PFA system globally.From the three CE Mark trials launched in 2018—IMPULSE, PEFCAT, and PEFCAT II—to the two large real-world studies in 2021—MANIFEST-PF, MANIFEST-17k, and EU-PORIA—and the ADVENT IDE trial announced in 2023,More than 20,000 patientsClinical data are recorded and published in clinical studies, and PFA products have the most comprehensive clinical research data among all products.

In the clinical setting,FARAPULSE™ PFA SystemHas accumulated a good reputation.OneA survey of U.S. electrophysiologists shows that: within the next 12 months, the usage of PFA is expected to increase from the current 9% to over 30%. The 70% high growth in Boston Scientific's electrophysiology business in the first quarter of 2024 also indirectly confirms the strong recognition by doctors of the pulsed field ablation technology. As of April, when Boston Scientific released its Q1 financial report, several U.S. hospitals had already purchased a second surgical device.

According to the "Chinese Guidelines for the Diagnosis and Treatment of Atrial Fibrillation 2023," China has approximately 12 million patients with atrial fibrillation. With the development of an aging population, the number of patients is bound to increase further.The launch of FARAPULSE™, a PFA system that has been thoroughly tested by doctors, patients, and the market, is expected toAllow more Chinese doctors and patients to enjoy the health benefits of cutting-edge innovations.

On the plateau of technology, humanity has explored for millennia, and some of the "low-hanging fruits" are being picked clean; future innovation will be a more complex and arduous journey. The medical field is no exception.

On this basis, whoever can seize the trend first and innovate new products will be able to expand their leading advantage.

Beyond its identity as a pioneer, Boston Scientific is also "a rare thinker in the wave of technology," having early on captured the industry's innovative trend towards "precision, ease of popularization, and improved efficiency," and applied it to guide technological innovation.

As for FARAPULSE™PFA SystemPrecise ablation of cardiac tissue, reduction in surgical difficulty, and significant shortening of operation time are the internalizations of these trend insights.

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