Recently, the National Medical Products Administration approved the innovative product registration application for "Disposable Cardiac Pulsed Field Ablation Catheter" by Hangzhou Nuomao Medical Technology Co., Ltd. This becomes the second cardiac pulse ablation product approved in China.

This product, composed of a catheter and connecting cable, is used in conjunction with the company's cardiac pulsed field ablation system. By controlling and delivering appropriately intense pulsed field energy, it selectively induces irreversible electroporation damage only to the myocardial cells in the targeted lesion area, thereby achieving the purpose of treating atrial fibrillation. This product provides more options for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

This isThe first basket/flower-shaped catheter in China to be approved for marketing by the NMPA, and the second cardiac pulse ablation product in China to receive approval.

Image Source: Nuomao

According to publicly available data, Professor Tang Min and Professor Niu Guodong et al. completed the first PFA surgery in Asia using the CardiPulse catheter on December 23, 2020.

PFA uses electrical pulses to ablate cardiac tissue causing rhythm abnormalities, and has attracted significant interest from physicians due to its potential to avoid complications associated with traditional thermal ablation. Clinically, numerous published papers have demonstrated that PFA is a more efficient and safer method for treating atrial fibrillation. Additionally, catheter-based pulse ablation can selectively ablate tissue, reducing the risk of damage to surrounding structures such as the esophagus and pulmonary veins.

PFA has advantages over traditional radiofrequency ablation and cryoablation technologies, such as tissue selectivity and non-thermal ablation. During surgical treatment, PFA does not cause damage to adjacent nerves, blood vessels, smooth muscles, or other myocardial tissues. PFA also offers advantages like lower operational difficulty, ease of use, high ablation efficiency, and time-saving, making it not only easy for doctors to adopt but also improving treatment efficiency.

According to Medtronic and Boston Scientific, the PFA system has been used in Europe and received positive feedback.Medtronic and Boston Scientific have also recently received approval from the U.S. Food and Drug Administration (FDA) to launch their PFA devices in the United States.

Image Source: MedTrend

• In January 2021, Boston Scientific's FARAPULSE Pulsed Field Ablation System became the first PFA system to receive CE certification.

• In November 2023, Medtronic's PulseSelect pulsed field ablation system received CE certification as the second PFA system.

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  On February 29, 2024, Johnson & Johnson's Varipulse pulsed field ablation system received its third CE certification.

• In December 2023, Medtronic's PulseSelect received the FDA's first approval for PFA treatment of paroxysmal and persistent atrial fibrillation.

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  On January 31, 2024, Boston Scientific announced that it has received FDA approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System.

• Johnson & Johnson is expected toReceived FDA approval in 2024.

• Jinjiang Electronics:In December 2023, the National Medical Products Administration approved the registration applications for two innovative products from Sichuan Jinjiang Electronic Medical Technology Co., Ltd.—the "Single-Use Cardiac Pulsed Field Ablation Catheter" and the "Pulsed Field Ablation Generator."
  

• Nuomao Electrophysiology: On March 11, 2024, the National Medical Products Administration received an innovative product registration application from Hangzhou Nuomao Electrophysiology Medical Technology Co., Ltd. for its disposable cardiac pulsed field ablation catheter.

In addition,Northcore Life, Ruidi Biotech, Aikema, Xuanyu Medical, Maiwei Medical, Hongtong Industry, Epflex (a subsidiary of Huitai Medical), Shangyang Medical (a subsidiary of MicroPort Electrophysiology)PFA products from innovative companies in China, such as Nuomao, have entered the NMPA special review process.

According to incomplete statistics,More than 40 companies globally and in China have laid out plans in the pulsed ablation field, with a wide variety of catheter forms. In the early stages, circular and petal shapes were particularly common.The approval and market launch of Nuomao's petal-shaped pulse catheter will play a significant role in China's domestically produced pulse ablation field. Its unique advantage of completing pulmonary vein isolation without relying on 3D technology is particularly beneficial for grassroots promotion. It is hoped that more new products and technologies will be approved and launched to benefit the vast number of patients with atrial fibrillation.