Recently, the National Medical Products Administration (NMPA) approved Medtronic's PFA product — the PulseSelect System for marketing. The system consists of two innovative products: the "Cardiac Pulsed Field Ablation Generator" and the "Single-Use Cardiac Pulsed Field Ablation Catheter." This is the first PFA product approved by the NMPA that can be used for both paroxysmal atrial fibrillation and persistent atrial fibrillation.
The above two products are used in conjunction, utilizing the non-thermal effects principle of pulsed electric fields to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with episodes lasting less than one year). Compared with traditional radiofrequency ablation and cryoablation products, this product can achieve selective destruction of myocardial tissue, avoiding the risk of surrounding tissue injury caused by temperature conduction.
It is reported that the PulseSelec pulsed electric field ablation system is a plug-and-play system that can be used with any mapping system and even directly paired with X-ray fluoroscopy imaging. The product is equipped with a phrenic nerve test pulse, which has a very low voltage. This test pulse can be used to assess whether the ablation catheter is close to the phrenic nerve before the formal ablation begins.In the global PFA market, Boston Scientific and Medtronic are leading the way, with these two companies expected to capture 60% of the atrial fibrillation market. Later entrant Johnson & Johnson aims to seize a share from emerging opportunities. Previously, Johnson & Johnson's pursuit of PFA opportunities has focused on the Varipulse catheter and the Thermocool Smarttouch SF dual-energy device. In addition to foreign markets, the vast space and development potential of the Chinese market also attract the attention of giants.China is the world's second-largest medical device market. As Boston Scientific and Medtronic’s PFA products have successively entered China, the globally watched PFA battle has extended from overseas to within the country. Domestic companies will also be drawn into this鲶鱼 effect. The successful launch of Boston Scientific and Medtronic’s PFA products in China marks their first-mover advantage in the competition among industry giants. However, this does not mean they can rest easy, as these electrophysiology giants also face pressure from China's local innovative forces.It is reported that, as of now, the NMPA has approved four PFA products. The Chinese-produced products are PulsedFA by Jinjiang Electronics and CardiPulse by Denovo Electrophysiology, while the overseas products are FARAPULSE by Boston Scientific and PulseSelect by Medtronic. Among them, PulsedFA and PulseSelect are circular ablation catheters, whereas CardiPulse and FARAPULSE are petal-shaped ablation catheters. These four products have their own unique design features. In addition, other companies such as XuanYu Medical, Aikangmai Medical, Xin Lytton, ZhouLing Medical, and YuanShan Medical have also entered the market. PFA products from HuiTai Medical, MicroElectrophysiology, and Maiwei Medical have entered various stages of clinical trials.The ICCD Organizing Committee provides a broader platform for exchange and cooperation. Everyone is welcome to join actively, seize every possible opportunity, and jointly promote the prosperous development of the medical industry.
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Among them, the CardiPulse Pulsed Field Ablation Catheter from Dennov EP is the first petal/basket-shaped catheter to be marketed in China. It can easily complete pulmonary vein isolation without relying on 3D mapping, potentially ushering in a new era of atrial fibrillation treatment. In June 2024, at Guangdong Provincial People's Hospital, the Dennov EP CardiPulse® Pulsed Field Ablation System was successfully used to perform a pulsed field ablation procedure for atrial fibrillation on a patient. This surgery set a new record in ablation time, with only 26 minutes of left atrial catheter operation and a total ablation time of 138 seconds, effortlessly achieving immediate pulmonary vein isolation.Sichuan Jinjiang Electronics' "PulsedFA" and "LEAD PFA Cardiac Pulsed Field Ablation System"YesChina's first approved cardiac pulsed field ablation (PFA) system, alsoIt is the world's first PFA product based on a full-magnetic positioning 3D system.This product not only possesses all the advantages of PFA pulsed electric field ablation technology, but also has multiple magnetic sensors embedded in the catheter, allowing for seamless integration with Jinjiang Electronics' proprietary LEAD-Mapping fully magnetic 3D positioning system.It is reported that the biggest advantage of Medtronic's PulseSelect system, which has been recently approved by the FDA in China, is its wide range of indications compared to the other three products available in China. These include persistent atrial fibrillation. The other three products are indicated only for paroxysmal atrial fibrillation, with persistent atrial fibrillation still under clinical investigation.As China's aging population continues to grow, domestic companies are closely following the PFA market. For instance, on August 12 this year, Shanghai XuanYu Medical Device Co., Ltd. ("XuanYu Medical" for short) announced the completion of a nearly 100-million-yuan A+ round of financing, reflecting the booming demand in China's electrophysiology market. HuiTai Medical also demonstrates significant advantages in its layout within the pulsed field ablation domain. Its ongoing projects include pulse ablation catheters, pulse ablation systems, high-density mapping catheters, and pressure radiofrequency generators, all currently in clinical trial stages, with expected approval for market launch by 2025. According to incomplete statistics, over 40 companies globally and in China are positioning themselves in the pulse ablation field, with various catheter designs including early models predominantly ring-shaped or petal-shaped. It is anticipated that an increasing number of domestically produced PFA products will be approved for market release, benefiting a large population of patients with atrial fibrillation.
According to Frost & Sullivan, 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 continuously increase, rising from 8.18% in 2025 to 38.87% in 2032.
Relevant industry insiders mentioned: "PFA is a revolutionary atrial fibrillation ablation technology. Compared with other atrial fibrillation ablation technologies, it is like electric vehicles replacing fuel vehicles, which requires a process. Currently, PFA is still in an early stage of development in the field of cardiac electrophysiology. Products made in China have not yet been widely used in clinical applications, and clinical data is still in the accumulation phase. However, as the technology continues to improve and achieves the optimal balance between safety and efficacy, it is expected to gradually replace radiofrequency ablation and cryoablation, becoming the mainstream atrial fibrillation ablation method."
It can be foreseen that China's PFA market will witness intense competition in the future. Not only is the market share of domestically produced products in the electrophysiology sector expected to increase, but patients in urgent need of treatment will also become the biggest beneficiaries under the balance of power among various competitors.
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