Boston Scientific's FARAPULSE Pulsed Field Ablation System Marks First Clinical Use in Mainland China, Ushering in a New Era for Atrial Fibrillation Treatment

Source: Device Home

Under the promotion of the Boao "Pilot First" policy, another world's first medical device has landed in China.

On February 22, Boston Scientific's FARAPULSE Pulsed Field Ablation System completed its "clinical debut" in mainland China at Boao Super Hospital in Hainan.

In recent years, pulsed field ablation has been rapidly emerging as the third frontier in atrial fibrillation ablation treatment. Leading this technological innovation is Boston Scientific's FARAPULSE. AsThe world's first PFA (Pulsed Field Ablation) system that has been launched and clinically appliedUpon the release of FARAPULSE's clinical data, its superior performance sparked a wave of PFA technology investment in the industry.

Currently, the situation of atrial fibrillation prevention and treatment in China is severe.Nearly 20 Million Patients with Atrial Fibrillation，With the development of an aging population, the number of patients is bound to increase further. Can the implementation of the most advanced global treatment technology turn a new chapter in atrial fibrillation treatment in China?

Director Yao Yan (right) leads the team to complete the first case in mainland China

FARAPULSE Pulsed Field Ablation System "Pilot Trial" Surgery

After the successful completion of the first FARAPULSE "Pilot Trial" surgery,Instrument Family had an in-depth conversation with the chief surgeon, Director Yao Yan from the Arrhythmia Center of Fuwai Hospital, Chinese Academy of Medical Sciences, at the first opportunity.

01

"Three-Board Axe" Advantages

Lead the Technological Revolution

It can be said that the birth of FARAPULSE has sparked a technological revolution.

Currently, there are two main ablation treatment modalities in clinical practice: radiofrequency ablation, which ablates myocardial cells through thermal effects; and cryoablation, which induces apoptosis of myocardial cells through freezing.Both adopt thermal conduction effect to achieve treatment., also known as the "Game of Ice and Fire" in the field of atrial fibrillation ablation.

Yao Yan, Director of the Arrhythmia Center at Fuwai Hospital, Chinese Academy of Medical Sciences, delivers a speech on site.

"Cryoablation and radiofrequency ablation were almost both developed around the same time, two to three decades ago."Director Yao Yan introduced: "These two methods each have their own advantages and disadvantages, with radiofrequency ablation occupying an absolute dominant position. However, after two or three decades, it can be said that the development of radiofrequency ablation has reached its limit, so everyone has been exploring a new treatment method."

Unique Insight, Reducing Fatal Complications

Traditional "ice and fire" ablation modes both have drawbacks: radiofrequency ablation may damage surrounding tissues and easily cause complications; cryoablation, on the other hand, may result in incomplete ablation, leading to the recurrence of atrial fibrillation.

Pulsed field ablation is the most significant innovation in the field of atrial fibrillation ablation after two to three decades of development. It breaks away from the mindset of "ice and fire," using pulsed electric fields to cause irreversible electroporation in cells, leading to cell death.Due to the unique non-thermal and tissue-selective damage of pulsed electric fields, they are safer and act faster compared to radiofrequency and cryoablation.

Particularly noteworthy is that PFA can prevent the occurrence of atrial-esophageal fistula, a fatal complication of atrial fibrillation radiofrequency ablation.

Director Yao Yan stated: "The biggest advantage of pulsed field ablation is that it addresses the most feared complication of radiofrequency ablation. While radiofrequency ablation is safe in the vast majority of cases, when complications do occur, they can be fatal."And PFA technology will minimize the risk of fatal complications.”

Cardiomyocytes are the most sensitive cells. Both radiofrequency ablation and cryoablation utilize temperature changes to ablate, causing coagulative necrosis of tissue, which may potentially damage surrounding tissues such as the esophagus and phrenic nerve.

PFA technology utilizes the characteristic that different cells have different ablation thresholds for electric field strength.PFA can selectively disrupt the myocardial cell membrane without compromising the integrity of adjacent tissues., addressing the biggest pain point that radiofrequency and cryoablation struggle to solve, adding an extra layer of safety for patients' lives.

Efficient and Convenient, "Embroidery" Turns into "Stamp"

Traditional radiofrequency and cryoablation still have the drawbacks of long operation time and a steep learning curve for doctors. However, the technical characteristics of PFA, combined with FARAPULSE's ingenious configuration design, significantly enhance the operational convenience of ablation procedures and reduce operation time.

In the early 1990s, cardiac ablation was introduced in China. Recalling his initial experience with this technology, Director Yao Yan said, "Handling an ablation catheter to make direct contact with a beating heart requires precision. Too little pressure results in poor contact and ineffective treatment; too much pressure can perforate the heart, leading to severe consequences and potentially requiring open-chest emergency surgery."

Under such high pressure, the difficulty of popularizing atrial fibrillation ablation is imaginable.

"Although an increasing number of advanced mapping devices have emerged in recent years, solving problems related to precision and speed, and with the addition of radiofrequency ablation also enhancing tissue pressure contact sensing, we now have hundreds of independent operators. However, I believe that given the size of our country, there should be thousands of professionals to meet the demand."

Director Yao Yan introduced: "After using FARAPULSE, we have found that its configuration and design principles significantly enhance safety and maneuverability, reducing the requirements for a doctor's operational skills, which helps further popularize its use."

FARAPULSE Pulsed Field Ablation System

*This product has not yet been launched in mainland China.

FARAPULSE has a unique ablation catheter design,Can be flexibly adjusted into two structures: petal and basket., adapting to different pulmonary vein morphologies and achieving stable contact. After the catheter is in place, energy can be delivered within five seconds, greatly enhancing clinical operational flexibility and surgical efficiency while reducing patient discomfort.Director Yao Yan revealed that the two FARAPULSE surgeries completed that day required only a little over twenty minutes of actual operation time.

For the convenience of FARAPULSE, Director Yao Yan gave a vivid metaphor: "The mainstream radiofrequency catheters now are somewhat like embroidery, but after using FARAPULSE, it becomes like stamping., will indeed greatly improve efficiency, safety, and effectiveness."

Effectiveness Proven, Sparking a Wave of Technological Reform

Meanwhile, FARAPULSE also shows excellent performance in terms of effectiveness. The immediate success of PFA surgery does not necessarily guarantee a favorable long-term prognosis, and the FARAPULSE system is the first PFA system with long-term follow-up data available at 1 year post-operation.

In 2022, two centers in Hamburg and Bad Oeynhausen, Germany, collected real-world data after the product launch.Data shows that the success rate of paroxysmal atrial fibrillation patients after 1 year of follow-up reaches 90%.

It is the comprehensive clinical data of FARAPULSE that has confirmed the strong development potential of pulsed field ablation in the field of atrial fibrillation ablation, making it a highly sought-after goal.

"Now, there is already an international wave of enthusiasm." Director Yao Yan remarked, "In the era of radiofrequency, there were only three or four international companies worldwide, plus a similar number of companies in China developing ablation devices for radiofrequency. However, after Boston Scientific’s product was clinically used and preliminary results were released, to my knowledge, currently, over thirty companies both inside and outside of China have already invested in the research and development of this product."

It is foreseeable that the safer, more convenient, and effective FARAPULSE is expected to greatly advance atrial fibrillation treatment in China.

02

Tens of Millions of People Benefited

A New Era of Atrial Fibrillation Treatment is on the Horizon

Atrial fibrillation, one of the most common types of tachyarrhythmia, is known as the "cardiovascular epidemic of the 21st century" and an invisible killer that cannot be ignored by the elderly. If left untreated for a long time, it can easily lead to stroke and heart failure, causing serious consequences. The annual hospitalization rate for patients is twice that of non-atrial fibrillation patients, and the all-cause mortality rate is 2 times higher than that of ordinary people.

As China accelerates into an aging society, the burden of atrial fibrillation on individuals, families, and even society continues to increase.

A stark reality is that there exists a vast unmet need for atrial fibrillation (AF) treatment in China. Catheter ablation, as the first-line recommended treatment for patients with AF who are unresponsive or intolerant to drug therapy, has a much lower penetration rate in China compared to the United States (0.7% vs 5.5% in 2020). In 2020, only 82,000 AF surgeries were performed in China, primarily concentrated in tertiary hospitals, leaving a large patient population facing significant difficulties in accessing care.

On the one hand, the high threshold for surgery has led to a significant shortage of skilled operators.

Director Yao Yan stated: "For instance, Japan and Northeast China have similar populations. However, in Japan, there are hundreds of doctors who can independently perform atrial fibrillation catheter ablation, whereas in the equally populous Northeast China, only dozens can do it independently. This gap is mainly due to the high difficulty of catheter ablation procedures, aside from economic constraints."

"The emergence of FARAPULSE will significantly lower the threshold for surgery, making the goal proposed by our country of 'major illnesses not leaving the county' more feasible. FARAPULSE has the potential to be普及到县一级的医院里面，造福很多患者."

On the other hand, as technology matures, the population suitable for surgery is gradually expanding, but there is still room for improvement.

Director Yao Yan introduced: "Twenty years ago, people generally had concerns about patients over 70. Later, some bold and skilled doctors gradually explored performing procedures on older patients under the cautious framework of medical institution regulations. Gradually, we expanded the indications to 75, 80, or even older because life expectancy has also been increasing."

FARAPULSE's enhancement in the safety and convenience of the procedure will better transition atrial fibrillation ablation to patients of more age groups and physical conditions. Director Yao Yan also stated:"Technologies like FARAPULSE have lower physical demands on patients, which is also an advantage in this aspect."

At the same time, the boost from policies will comprehensively accelerate the implementation of new technologies. Thanks to the special policy support in the Boao Lecheng Pilot Zone, patients with atrial fibrillation in China can now access the most advanced diagnostic and treatment technologies available globally.

As early as 2019, Boston Scientific established a strategic partnership with Lecheng Pilot Zone, and since then, the cooperation between the two parties has continued to deepen and expand.In November 2022, the two parties held a signing ceremony for the "Strategic Cooperation Agreement 2.0 under True Research Leadership" at the 5th CIIE, jointly discussing cooperation upgrades and completing the advancement from version 1.0 to version 2.0 of their collaboration.

The introduction of FARAPULSE at Boao Super Hospital this time is another achievement of the deepened cooperation between Boston Scientific and the Lecheng Pilot Zone. As Liu Tongting, the executive vice president of Boao Super Hospital, stated: “This collaboration with Fuwai Hospital of the Chinese Academy of Medical Sciences and Boston Scientific is expected to accelerate the entry of atrial fibrillation treatment in China into the pulsed field ablation era.”

It is expected that, with the joint efforts of all parties, FARAPULSE will accelerate its market entry in China, completely rewriting the current challenging situation in atrial fibrillation treatment and providing more health protection for patients with atrial fibrillation.