Denovo EP's CardiPulse: China's First Domestically Developed Petal-Shaped PFA System Receives NMPA Approval

Recently, Hangzhou Nuomao Medical Technology Co., Ltd. (hereinafter referred to as "Nuomao") announced that itsCardiPulse^®Single-use Cardiac Pulsed Field Ablation Catheter (NMPA Approval No. 20243010461) and Cardiac Pulsed Field Ablation Generator (NMPA Approval No. 20243010504)(The following is collectively referred to as: "CardiPulse")^®"Pulsed Electric Field Ablation System" Officially Approved for Marketing by the National Medical Products AdministrationHas become the first petal-shaped pulsed electric field ablation system in China to be approved and possess full independent intellectual property rights.

86.7% success rate of atrial fibrillation ablation at 12 months post-operation and only 0.7% major adverse event rate fully demonstrate CardiPulse.^®Efficacy and Safety of Pulsed Field Ablation System in Patients with Paroxysmal Atrial FibrillationThe successful launch of this product will provide a new generation of safer, more efficient, and more convenient atrial fibrillation treatment solutions for clinical use. Its official commercial development will also lead to the rapid growth of the atrial fibrillation ablation market, opening a new era of atrial fibrillation ablation.

CardiPulse^®The pulsed electric field ablation system consists of a single-use cardiac pulsed electric field ablation catheter, a steerable sheath, and a cardiac pulsed electric field ablation generator.

CardiPulse^®Pulsed Field Ablation System ablates myocardial tissue in a non-thermal manner, with tissue specificity, allowing for the ablation of myocardial tissue while preserving surrounding tissue structures, avoiding conductive thermal injury and barotrauma. Through extensive animal experiments and exploratory clinical studies in the early stages, ablation parameters were continuously refined, demonstrating excellent performance in both procedural safety and long-term effectiveness.

(1) The head end features a 6-petal flower design, with each petal containing 3 electrodes, and one of the petals is equipped with an additional positioning electrode.

(2) The catheter has a flexible and variable shape (basket/petal), with three diameter specifications to perfectly fit different pulmonary vein structures.

(3) During the procedure, the catheter can quickly reach the pulmonary vein guided by a guidewire, and pulmonary vein isolation can be completed without relying on three-dimensional mapping. This simplifies the operator's workflow and effectively shortens the learning curve.

With an inner diameter of 12Fr, the distal end can be unidirectionally adjusted. It has a smaller bending radius and a larger bending angle, facilitating smooth navigation to different positions of the pulmonary veins.

Outputs bipolar biphasic pulse energy and provides Pulse Index (PI) to assist in intraoperative ablation. Equipped with a capacitive touch screen, the simple UI operation interface facilitates intraoperative use.

As an exploratory application, the product was successfully used by Professor Tang Min and Professor Niu Guodong, along with their team members from the Arrhythmia Center of Fuwai Hospital, Chinese Academy of Medical Sciences, to complete the first-ever pulsed atrial fibrillation ablation surgery in Asia on December 23, 2020, at Yunnan Fuwai Cardiovascular Hospital.

As a preclinical study,Professor Zulu Wang's team from the Department of Cardiology, General Hospital of Northern Theater Command, People's Liberation Army of China, as the principal investigatorOn October 27, 2021, the system was successfully applied to treat two patients with paroxysmal atrial fibrillation, marking CardiPulse.^®Multicenter Registration Clinical Trial PLEASE-AF Study Officially Launched.

This study involved a total of 28 researchers participating in the surgery, strictly adhering to the clinical trial protocol, enrolling 143 patients with drug-refractory, symptomatic, paroxysmal atrial fibrillation.The primary effectiveness endpoint was the success rate of atrial fibrillation ablation at 12 months. Safety endpoints included the incidence of major adverse events (MAE) related to the device or procedure within 3 months post-operation, the incidence of severe adverse events within 12 months, and the incidence of device-related adverse events.

CardiPulse^®Follow-up results of the multicenter registration clinical trial PLEASE-AF Study show:

1) The immediate success rate of pulmonary vein isolation during the operation was 100%, and the success rate of atrial fibrillation ablation at 12 months post-operation was 86.7% (124/143), fully demonstrating the effectiveness of CardiPulse.^®Effectiveness of Treatment in Patients with Paroxysmal Atrial Fibrillation.

2) The incidence of major adverse events (MAE) related to the device or surgery within 3 months post-operation was 0.7% (1/143), fully demonstrating the safety of CardiPulse.^®The safety of treating patients with paroxysmal atrial fibrillation has met the current clinical safety requirements for atrial fibrillation catheter ablation products. A small amount of pericardial effusion was found in one case (0.7%) of the subjects after the operation, which disappeared without sequelae after conservative treatment with medication.

3) The incidence rates of death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve paralysis, systemic embolism, pericarditis, cardiac tamponade, atrioesophageal fistula, and severe vascular access complications within three months post-operation were all 0%.

Experts in this field in China have provided strong support for the development of this project's technology and the clinical application of new technologies, and have expressed full recognition of the product. Nuomao CardiPulse^®The successful listing marks a solid step forward in the research, development, and production of electrophysiology devices in China, showcasing the outstanding capabilities of China's self-developed technologies to the world. This achievement not only demonstrates that our technology is aligned with international standards, opening the pathway for China’s advanced technology and products for arrhythmia to reach the global stage, but also means that a large number of patients and operators in China will benefit. We look forward to the future with CardiPulse.^®Representing China-produced, independently developed devices and instruments that can play a greater role globally, contributing more to the global cardiovascular health cause.

Atrial fibrillation is a type of heart disease that poses a serious threat to human health. The mortality rate, readmission rate, stroke incidence, and decline in quality of life are significantly higher in patients with atrial fibrillation compared to those without the condition. According to epidemiological survey statistics from the Atrial Fibrillation Center, the prevalence of atrial fibrillation among adults in China is 1.6%. Based on this estimate, the total number of people currently suffering from atrial fibrillation in China is approximately 20 million.

Continuous advancements in medical technology are providing atrial fibrillation (AF) patients with an increasing number of treatment options. Among these, catheter ablation has become the mainstream approach for maintaining sinus rhythm in AF patients and represents the largest and fastest-growing segment within electrophysiology catheter ablation procedures. In 2015, approximately 118,000 electrophysiology catheter ablation procedures were performed in China, with only 25,000 being AF catheter ablations. By 2022, the total number of electrophysiology catheter ablation procedures in China had increased to about 250,000, with AF catheter ablations rising to 130,000. The market urgently needs a new type of catheter ablation technology that is safer, easier to operate, and more efficient.

Pulsed Field Ablation Emerges. In recent years, the safety and effectiveness of pulsed field ablation technology in the field of atrial fibrillation treatment have been supported by numerous strong pieces of evidence-based medical evidence. The operation time has been significantly shortened, and it is expected to become a new method that can safely replace other ablation technologies. The in-depth research and development and successful commercialization of pulsed field ablation technology will lead the atrial fibrillation ablation market into a new phase of rapid growth, ushering in a new era of atrial fibrillation ablation technology.

Nuomao was founded in 2016 as a subsidiary of Nuomao Medical, focusing on the field of cardiac electrophysiology and prevention and treatment of cardioembolic stroke. Several core product invention patents have been authorized in China, the United States, and Europe. Nuomao is the first to enter the PFA atrial fibrillation ablation market, with a comprehensive layout for overall arrhythmia treatment solutions. Its core products include CardiPulse.^®Pulsed Field Ablation System, SeaLA™ Left Atrial Appendage Occluder System, and E-SeaLA™ Integrated Ablation and Occlusion Left Atrial Appendage Occluder, etc.

Nuomao CardiPulse^®Approved by the NMPA in March 2024, becoming the first domestically produced and fully independently intellectual property-owned petal-shaped pulsed field ablation system to be launched in China. SeaLA™ was officially launched in China in November 2022. Additionally, E-SeaLA™ has completed the world's first clinical trial application for left atrial appendage occlusion combined with left atrial appendage electrical isolation.

Nuomao, adhering to the vision of "making medical innovation faster and more accessible" from its parent company DeNuo Medical Group, continues to innovate and iterate in the field of arrhythmia, allowing more patients to receive treatment earlier and benefiting the world.