Boston Scientific's FARAPULSE PFA System Deployed at Renji Hospital, Expanding Clinical Access in China

It is worth mentioning that on July 8, 2024, the FARAPULSE series of pulsed field ablation products officially received approval from the NMPA, becoming the third pulsed field ablation system for cardiac applications to be approved by the NMPA. This product series includes the FARAWAVE single-use cardiac pulsed field ablation catheter and the FARASTAR cardiac pulsed field ablation system.

With the support of policies such as the "Innovation Channel," "Pilot Initiatives," and the "Hong Kong-Macao Medicine and Device Connect," the FARAPULSE series has been introduced for clinical use in Hainan's Lecheng and the Greater Bay Area, bringing good news to local patients. The introduction of this system at Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, will further expand its clinical application scenarios, providing more patients with advanced and effective treatment options.

The core components of the FARAPULSE PFA System each have unique features, collectively enhancing the precision and efficiency of the procedure. Among them, the FARAWAVE Pulse Ablation Catheter stands out with its distinctive deformable tip design, capable of flexibly transforming into a basket shape and a petal shape, perfectly conforming to the patient's individualized pulmonary vein anatomy to achieve safe, simple, and efficient pulmonary vein isolation.

The innovative advantages of this system are mainly reflected in the following four aspects:

1. Multi-level Pulse Electric Field Ablation Technology: The FARAPULSE PFA system is equipped with an advanced energy source, utilizing bipolar and biphasic waveforms in conjunction with proprietary pulses, offering three voltage options—1800V, 1900V, and 2000V. This design not only enhances tissue selectivity but also enables rapid energy delivery while minimizing damage to surrounding tissues, creating continuous, transmural, and durable ablation lesions. After years of iterative optimization, the system has achieved dose verification in terms of catheter, waveform, and application sequence, ensuring superior clinical outcomes.

Second, the unique "petal" structure catheter: The FARAWAVE ablation catheter adopts an innovative 12Fr diameter design, with five deployable "petals" equipped at the distal end. Each "petal" has four electrodes. The shape can be easily controlled via a slider button on the handle, allowing it to expand from a "bud" state to a "fully bloomed flower." This spline structure not only enhances the contact between the catheter and the myocardial tissue of the pulmonary vein vestibule but also significantly improves the flexibility and efficiency of the surgery, reducing patient discomfort.

Third, the standardized ablation process: The FARAPULSE PFA system adopts a standardized ablation process, performing four basket-shaped and four petal-shaped ablations on each pulmonary vein respectively. Combined with catheter rotation, it ensures sufficient ablation dosage and electric field vectors, achieving complete ablation of myocardial cells. This process enhances the fluency and efficiency of the surgery.

4. Shorter Learning Curve: The system features a simple and intuitive interface, allowing the isolation of a pulmonary vein vestibule with just three buttons. The guidewire design stabilizes the catheter tip, while the variable tip shape meets the needs of various surgical procedures. Efficient energy delivery reduces stabilization time, lowers operational difficulty, and helps doctors quickly master the technique.

As the world's leading PFA system, the FARAPULSE PFA System has treated over 70,000 patients globally, emerging as a new option for treating drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

As a result, the product has received certifications from multiple countries. The system was granted Breakthrough Device Designation by the U.S. FDA in 2019, obtained CE certification in the European Union in 2021, and has been used in Europe for the treatment of paroxysmal atrial fibrillation. In December 2021, the system passed the review by the Center for Medical Device Evaluation under China's National Medical Products Administration and entered the special review process for innovative medical devices. In July 2023, Boston Scientific successfully completed the pilot project at Boao Super Hospital, involving 12 centers, 41 operators, and 32 patients with atrial fibrillation. On July 8, 2024, the FARAPULSE series of pulsed field ablation products were officially approved for marketing in China.

Over the past two decades, radiofrequency and cryoablation technologies have been the dominant techniques in the field of cardiac ablation. However, the rise of pulsed field ablation (PFA) technology, with its advantages such as short ablation time, significant treatment outcomes, and fewer side effects, has quickly made it a standout in the cardiac ablation field. It is regarded as "the leading cardiac ablation technology of the next decade." In recent years, PFA technology has made substantial progress in both clinical applications and commercialization.

So far, four PFA products have successfully received NMPA approval in China, coming respectively from Jinjiang Electronics, Denovo Electrophysiology, Boston Scientific, and Medtronic.

Specifically, in December 2023, Jinjiang Electronics' LEAD-PFA Cardiac Pulse Field Ablation Instrument became the first pulse ablation system in China to receive NMPA approval for marketing. This product is the world's first PFA product based on a full magnetic positioning 3D system, which not only possesses all the advantages of PFA technology but also seamlessly integrates with Jinjiang Electronics' proprietary LEAD-Mapping full magnetic positioning 3D system. It combines multiple functions such as 3D modeling, mapping, and ablation, enabling green electrophysiological procedures (i.e., radiation-free surgeries) and significantly reducing occupational risks for surgeons.

In March 2024, CardiPulse®, a disposable cardiac pulse field ablation catheter and cardiac pulse field ablation system developed by D&H EP, gained regulatory approval and was launched in China. This marked the first petal-shaped pulse field ablation system with fully independent intellectual property rights in China. The success rate of atrial fibrillation ablation using CardiPulse® reached 86.7% after 12 months post-operation, with a major adverse event rate of only 0.7%. These results demonstrate the high efficacy and safety of the CardiPulse® pulse field ablation system in treating patients with paroxysmal atrial fibrillation.

In September of the same year, Medtronic's PulseSelect pulsed field ablation system was also approved in China. The system achieves rapid and effective pulmonary vein isolation through consistent and predictable energy delivery and catheter manipulation, providing clinicians with the possibility of seamlessly transitioning to PFA technology within their preferred workflow. Additionally, the PulseSelect generator features automatic overcurrent detection, which can automatically detect and prevent excessive current delivery, further enhancing safety during the treatment process.

In addition to the products already on the market, according to incomplete statistics from VCBeat, more than 10 companies currently have PFA product pipelines and are focusing on the treatment of persistent atrial fibrillation. For example, HT Medical's magnetic pressure ablation system has completed patient enrollment for pre-market clinical trials for persistent atrial fibrillation; HeartPath Medical has built an integrated 3D PFA product portfolio of "magnetic-electric 3D + magnetic-electric PFA," which is expected to become the world’s only PFA product portfolio capable of mapping persistent atrial fibrillation and achieving personalized ablation; Jianhu Medical has completed the first clinical study using an innovative integrated dielectric 3D + nanosecond pulse treatment system for persistent atrial fibrillation.

In terms of innovative technologies, domestic companies have also demonstrated strong capabilities. The three-dimensional dielectric mapping technology developed by Jianhu Medical measures and tracks changes in the dielectric constant of different types of tissue cells in the human body under the influence of an electric field, enabling real-time, high-precision 3D positioning and imaging of human tissue structures. Meanwhile, Xinhanglu Medicine has pioneered the "Four-Dimensional Cardiac Mapping System" – the DePolar mapping system, which seamlessly integrates magnetic and electrical contact mapping technology with non-contact magnetic and electrical mapping technology. With continuous technological advancements and the expanding range of indications, more patients will benefit from this innovative technology. At the same time, the research, development, and innovation efforts of Chinese companies in the PFA field will continue to inject vitality into the development of this field.