CardiPulse: A Homegrown Breakthrough in Cardiac Electrophysiology Blossoms from China's New Silicon Valley

Around the Spring Festival of the Yi-Si Year, Hangzhou emerged as a globally recognized hub of innovation. Whether it was national-level innovative products or profound explorations (DeepSeek), or the humanoid robot that performed the Yangge dance at the Spring Festival Gala (Unitree Robotics)，Hangzhou is emerging with a momentum like breaking bamboo.The numerous high-tech companies represented by the "Six Little Dragons" have amazed people and even sparked a "defensive breakdown"-style heated discussion among Jiangsu's official media.

InBefore the Rise of the "Six Little Dragons," Hangzhou was Best Known for its Labels: West Lake, Alibaba, and Internet Celebrity Culture.Mentioning technology-driven cities,PeopleOften the first thing that comes to mindTheIt's Shenzhen, where there are admirable companies such as Huawei, BYD, DJI, and more.

More than a decade ago, the top technology companies in China's medical device field were mainly concentrated in Shanghai, Beijing, and Shenzhen, while Hangzhou was not as prominent at that time.TheIs a group located in TongluA small business producing rigid endoscopes and minimally invasive surgical instruments. After more than a decade of development, Hangzhou has now given rise to numerous well-known medical technology companies, such as BrainCo, Venus Medtech, Zylox-Tonbridge, MicroPort Medical, Nuomao, and Kangji Medical, among others. These enterprises have seized the transformative opportunities in the medical device sector, rapidly establishing themselves as leaders in specific fields within China. This has also propelled Hangzhou to become a significant player in the medical device industry."Barren Land" Transformed into a Medical Device Innovation Hub.

Take Nuomao as an example, this company has single-handedly enabled"Hangzhou Electrophysiology Solutions" Expand Across China. As electrophysiology in ChinaThe Enterprise Remains FocusedInRadiofrequencyAnd Cryoablation CatheterR&DAt that time, Nuomao had already taken the lead in starting.PFA (Pulsed Field Ablation) Ablation Technology R&D, and in 2020Completed the first in AsiaExamplePFAAtrial FibrillationAblation Surgery, andAfter years of technical accumulation andClinical validation,In2024At the beginning of the year,ItsPFA Technology——CardiPulse Receives NMPA Approval for Market Launch.

InCardiPulseOver the years of research and development,Nuomao performsFinishedCareful polishing.Initial DesignGoTheThe most common in the industryTheSolution: Annular design (This design is the most mature, requiring only fine-tuning of the pulmonary circulation.)MakeUse).HoweverIn subsequent preclinical studies, it was found that"The 'circular design' is not perfect, and thus Nuomao begins its exploration of CardiPulse."“Modded”Through extensive trials,FinallyConfirmed"Six-Petal" Flower Design.This innovative design addresses the clinical pain points that were not fully met by previous flower-shaped and loop catheters, making atrial fibrillation ablation procedures easier, signals clearer, and the ablation range wider.，Achieve TrueOne-shot Complete Ablation。

The subsequent multi-center registration clinical research conducted nationwide also confirmedItsAdvantages: The success rate of immediate pulmonary vein isolation during surgery is100%，PostoperativeThe success rate of AF ablation at 12 months was 86.7%.，PostoperativeThe incidence rate of major adverse events (MAE) related to devices or surgeries within 3 months was 0.7%. After its market launch, CardiPulse quickly gained clinical recognition due to its unique product design and excellent performance. Within a year of its launch, CardiPulse has been introduced into the catheterization labs of over a hundred hospitals across China, and will serve patients nationwide.2000Atrial Fibrillation Patients Bring a Brand-New Treatment Experience.

However, in this"In the 'ultra-competitive' new era of electrophysiology, no single company can dominate the market with just one product." Companies like Boston Scientific and Johnson & Johnson not only have multiple innovative PFA products but also possess 3D mapping technology and left atrial appendage closure technology, forming a comprehensive solution for arrhythmia. Nuomao Electrophysiology has also made early strategic moves by signing an exclusive licensing agreement in 2021 with APN Health, a U.S.-based 3D cardiac imaging system company, to acquire its core product.：Navik 3D Imaging and Navigation System: Solving the "Eye" Problem in Electrophysiological Ablation, Making Electrophysiological Ablation More Reliable.

In addition, Nuomao has integrated its left atrial appendage occlusion product line, forming a unique atrial fibrillation solution."One-stop solution". CurrentlyItsThe left atrial appendage occlusion product line consists of two core products.SeaLA and E-SeaLA, where the SeaLA Left Atrial Appendage Occluder System was approved for marketing by the NMPA in 2022, and E-SeaLA is currently in the exploratory clinical research stage. Notably, E-SeaLA is a left atrial appendage occluder with ablation functionality, utilizing PFA energy-based non-thermal ablation technology to integrate efficient left atrial appendage electrical isolation with occlusion.World's First"Structural Electrophysiology"Concept, when used withWhen used in conjunction, CardiPulse will redefine the "one-stop solution" for atrial fibrillation.。

Of course, arrhythmia includes other atrial tachycardias (non-atrial fibrillation) in addition to atrial fibrillation.AndVentricular Tachycardia. Due to non-atrial fibrillationDiseaseTheThe ablation site is different from the atrial fibrillation ablation site in physiological structure, so it cannot be achieved throughCardiPulse catheter for treatment requires a completely new ablation catheter. In this regard, NuomaoTheNew TypeFocalPFACatheterAlsoAlreadyIn development, the future will be withCardiPulse、Navik 3DAndE-SeaLAForm a completeSolution.

For NuomaoEnterpriseGenerally speaking, this isBreak the Import Monopoly and Drive Industry TransformationThe best era. In an era dominated by thermal ablation technology, companies in China are looking to break through.Imported brands for many yearsAccumulationTheTechnical barriers and brand effectEasier said than done。PFAThe advent of the era has given many Chinese companies the opportunity to overtake on a curve.Jinjiang Electronics, Nuomao, HuitaiMedical, Xuan YuHealthcare and othersObtainApproved for marketing by the NMPA, with progress surpassing some imported enterprises.In terms of product performance, someBrandIn the clinical settingEven moreObtainBetter than imported productsPositive reviews。In centralized procurementIn today's normalized environment, with continuous tightening of medical insurance cost controls,If domestic enterprises can furtherExpand the Advantages of Cost Control, continuously cultivate the market and orderly penetrate the grassroots,UpholdThe original intention of letting innovative technology better serve doctors and patients,Then it can be foreseen that the electrophysiology industry in ChinaThe pattern will soon be reshaped.