Domestic Cardiovascular Devices Surge with 77% Share of NMPA-Approved Innovations in 2023

Feb 14, 2024 21:57 CST Updated 21:57

Core Medical

Artificial Heart Series Product Developer

MicroPort EP

R&D Producer of Cardiac Electrophysiology Interventional Medical Devices

Hanyu Medical

Structural Heart Disease Interventional Devices and Electrophysiology Product R&D, Manufacturer

TINGSN

Developer of Cardiac Interventional Treatment Devices

Valgen Medtech

Minimally Invasive Interventional Device Developer

Cryofocus

Minimally Invasive Interventional Cryotherapy Device Developer

Jinjiang Electronic

Developer of electrophysiology products

Conavi Medical

Minimally Invasive Cardiovascular Surgical Image Guidance Technology Developer

Corindus

Research on Robot-Assisted Vascular Intervention Treatment

Source of the article:Heart NotCome;Editor: Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

In 2023,National Medical Products Administration (NMPA)Approved17 Innovative Medical Devices Related to Cardiovascular, Among Which13 are domestically innovative products, accounting for 77%.。

This article willA Review of These 13 China-Produced Cardiovascular Innovative Devices and Their Corresponding Companies (Sorted by Approval Time), showcasing China's innovation and advancements in the field of cardiovascular devices, and providing insights into the technological level, R&D capabilities, and market competitiveness within this sector in China. At the same time, it serves as a reference for relevant enterprises, research institutions, and regulatory bodies, allowing a wide range of patients and doctors to understand the latest cardiovascular device products, offering more information and basis for their treatment options.

# Coronary CTFractional Flow Reserve Calculation Software

▲Coronary CT Blood Flow Reserve Fraction Calculation Software Interface (OriginOfficial CompanyNet)

Product Name：Coronary CT Blood Flow Reserve Fraction Calculation Software

Manufacturer: Pulse Medical Imaging Technology (Shanghai) Co., Ltd.

Approval Date：2023/4/4

National Medical Device Registration Approval：20233210450

The ProductCT Blood Flow Reserve Fraction Calculated Based on Coronary CT Angiography Images, used to assist in evaluating the functional myocardial ischemia status of patients with stable coronary artery disease. It can help clinicians determine whether coronary stenosis causes myocardial ischemia and decide if the patient needs further interventional examination and treatment.As a supplement to traditional imaging examinations, the marketing of corresponding software will help further.ReduceReduced Diagnosis Time and Financial Burden for Patients。

Company Overview:

Pulse Medical Imaging Technology (Shanghai) Co., Ltd.Founded in 2015, it isPrecision Diagnosis in Pan-Vascular InterventionsThe pioneer and leader, closely collaborating with renowned institutions and hospitals such as Shanghai Jiao Tong University, the National Center for Cardiovascular Diseases, and the National Clinical Research Center for Cardiovascular Diseases, leveraging the innovative advantages of integrating industry, academia, research, and medicine with market-oriented approaches, has pioneered internationally inPrecision Diagnosis Solution for Coronary PhysiologyNew Directions.

Pulse Medical Imaging Technology (Shanghai) Co., Ltd.'s coronary precision diagnosis product line covers multimodal IVUS/OCT/QFR imaging fusion catheters and systems for outpatient screening and physical examinations of coronary heart disease, precise diagnosis during interventional procedures, PCI navigation, and guidance for complex coronary interventions.

Latest! Three Innovative Medical Devices Approved for Marketing

# Coronary Artery Function Measurement System

▲Coronary Artery Function Measurement System（OriginOfficial CompanyWebsite)

Product Name: Coronary Functional Measurement System

Manufacturer: Suzhou Rainmed Medical Technology Co., Ltd.

Approval Date: 2023/4/20

National Medical Device Registration Certificate: 20233070520

This product consists of a workstation, sensor bracket, IBP lead wire, and IBP signal input cable (optional), and is exclusively intended for use with the disposable invasive pressure sensors manufactured by Suzhou Rainmed Medical Technology Co., Ltd. The product performs hemodynamic analysis by segmenting blood vessels and reconstructing three-dimensional images from coronary angiography, obtaining blood flow velocity, and combining it with aortic pressure measurements taken by the invasive pressure sensor.Evaluation of Coronary Angiography Microcirculatory Resistance Index (caIMR),Assist CliniciansEvaluation of Coronary Microcirculation Function in Patients。

Company Profile:

Suzhou Rainmed Medical Technology Co., Ltd.Founded in 2014 and listed on the Hong Kong Stock Exchange in July 2022, committed to becoming a global leaderVascular Interventional Surgical RobotThe company is currently focused on the design, development, and commercialization of the coronary angiography-based fractional flow reserve system (caFFR system) and the coronary angiography-based microvascular resistance index system (caIMR system).

CompanyCore Products: caFFR System and caIMR SystemUsed to assess the severity of myocardial ischemia caused by coronary artery stenosis and microcirculatory dysfunction, aiming to replace the use of pressure wires, significantly reduce the risk of technical errors and operation time, thereby improving physiological assessment.Is expected to become the companyThe Core and Key Modules of Future Vascular Interventional Surgical Robots。

Latest! Three Innovative Medical Devices Approved for Marketing

# Implantable Left Ventricular Assist System

▲Implantable Left Ventricular Assist System（OriginOfficial CompanyWebsite)

Product Name: Implantable Left Ventricular Assist System

Manufacturer: Shenzhen Core Medical Technology Co., Ltd.

Approval Date: 2023/6/5

National Medical Device Registration Certificate: 20233120716

This product is composed of implantable components, external components, and surgical accessories, and is used in conjunction with a specific artificial blood vessel.Mechanical Support for Circulation in Patients with Advanced Refractory Left Heart Failure, used as a transitional treatment before heart transplantation or to restore heart function.

This product is the third generation.Non-contact Magnetic Levitation Centrifugal PumpThe core technology is mainly disk motor technology, which uses position sensors to detect and control the rotor's speed and suspension height. The motor of this product only uses one set of stator coils to simultaneously control the rotor's rotation and suspension, featuring a simpler structure.Lighter weight and smaller size、Lower power consumption, smaller surgical incisions in clinical applications, faster patient recovery, a wider range of suitable patients, and reduced risk of thrombosis caused by blood pump heat.

Company Overview:

Shenzhen Core Medical Technology Co., Ltd. was established in 2016, focusing on the research and development and production of high-end innovative medical device products such as mechanical circulatory assist devices ("artificial hearts"), achieving a comprehensive layout in the field of implantable and interventional artificial hearts.Since 2019, Core Medical has completed four rounds of financing in four consecutive years, showing steady development momentum.

In the miniaturization of artificial hearts,This approval for marketingCorheart®6It is an implantable full magnetic levitation artificial heart independently developed by Core Medical, with a blood pump diameter of only 34 millimeters, thickness of 26 millimeters, and weight of approximately 90 grams.grams, with a 40% reduction in diameter and a 50% reduction in weight compared to similar products on the market. According to the company, this is currentlyThe World's Smallest and Lightest Artificial Heart。At the same time, in product lines such as the interventional artificial heart CorVad, Core Medical has achieved the generation of larger flow within a smaller interventional size. Its self-designed micro motor and control technology have further reduced the risk of hemolysis, enhancing product stability and long-term operational reliability.

Latest! Another Artificial Heart Approved by NMPA!

# MicroPort EP: Cryoablation Equipment and Balloon Catheters

▲Cryogenic Ablation Equipment and Balloon Catheters（OriginOfficial CompanyNet)

Product Name:Cryotherapy Ablation Devices,Balloon Cryoablation Catheter

Manufacturer: Shanghai MicroPort EP MedTech Co., Ltd.

Approval Date: 2023/8/23

National Medical Device Registration Certificate:20233011226 、20233011225

Used together, forTreatment of Drug-Resistant, Recurrent, Symptomatic Paroxysmal Atrial Fibrillation, belonging toFirst of its kind in ChinaIt adopts target temperature control technology and multi-channel temperature measurement technology, which can control the internal temperature of the balloon and monitor the surface temperature of the balloon during the treatment process to ensure a safer surgery. The product's market launch can further meet China's clinical needs in the field of paroxysmal atrial fibrillation treatment.

Company Overview:

Shanghai MicroPort EP MedTech Co., Ltd.Founded in 2010, it is a company focused onField of Electrophysiological Interventional Diagnosis and Ablation TherapyA high-tech enterprise engaged in the research, development, production, and sales of innovative medical devices, dedicated to providing "an integrated solution for diagnosis and ablation treatment centered on precise interventional navigation." On August 31, 2022, the company was listed on the STAR Market of the Shanghai Stock Exchange (688351.SH).

The company's core businesses include cardiac electrophysiology diagnostic and ablation catheters, cardiac electrophysiology mapping systems, and radiofrequency ablation systems, achieving a complete layout in the cardiac electrophysiology field.The FirstChinese manufacturers capable of providing a complete solution for 3D cardiac electrophysiology devices and consumables。

MicroPort EP! Two Cryoablation Products Approved for Marketing

# Mitral Valve Clip System

▲Mitral Valve Clip System（OriginOfficial CompanyNet)

Product Name: Mitral Valve Clip System

Manufacturer: Shanghai Hanyu Medical Technology Co., Ltd.

Approval Date: 2023/9/7

National Medical Device Registration Certificate: 20233131292

The product consists of a mitral clip, a delivery system, and a transvalvular device. The delivery system comprises a delivery tool, a pusher, a loader, a catheter sheath, and a dilator. Using this product during surgery eliminates the need for cardiac arrest and extracorporeal circulation, resulting in a smaller incision, shorter surgical access, and direct positioning. Additionally, the procedure is guided solely by ultrasound intervention, ensuring that neither the doctor nor the patient is exposed to X-ray radiation. The mitral clip has a larger capture range, which facilitates operation, and its closed-loop design ensures stability by preventing the clip arms from separating easily.

The product adoptsTransapical Approach, applicable to patients assessed by a professional cardiac team as having a high surgical risk and suitable mitral valve anatomy.Degenerative Mitral Regurgitation (MR≥3+)Patients. The launch of this product will provide more options for clinical treatment.

Company Overview:

Shanghai Hanyu Medical Technology Co., Ltd.Founded in 2016, mainly engaged inStructural Heart Disease Interventional Devices and Electrophysiology ProductsThe research, production, and commercialization. The company has independently developed and perfected its unique core technology platform, covering the complete lifecycle of products from early design to process development and industrialization, laying a solid foundation for the steady progress of existing R&D projects and the continuous expansion of the product pipeline.

ValveClamp® Mitral Valve Clip SystemIt is the first commercially launched mitral regurgitation interventional repair device produced in China by Hanyu Medical.The original patent design comes from the team of Academician Ge Junbo from Zhongshan Hospital, and Hanyu Medical has obtained the patent authorization and carried out clinical scientific and technological achievement transformation.

First Domestic Product! Mitral Regurgitation Intervention Device Launched

# Single-Use Intracardiac Ultrasound Diagnostic Catheter

▲Single-Use Intracardiac Ultrasound Diagnostic Catheter（OriginOfficial CompanyNetwork)

Product Name: Single-Use Intracardiac Ultrasound Diagnostic Catheter

Manufacturer: Jiangsu TINGSN Technology Co., Ltd.

Approval Date: 2023/11/28

National Medical Device Registration Certificate: 20233061761

This product is composed of a catheter body, an operating handle, and a connector. It is used in conjunction with the company's portable color ultrasound diagnostic instrument and is suitable for use in medical institutions.Ultrasound Imaging of the Heart, Great Vessels, and Intracardiac Anatomy。

This product performs two-dimensional imaging and three-dimensional modeling of the cardiac region using high-frequency ultrasound, enabling accurate, rapid, and efficient ultrasound-guided surgery. It provides real-time, precise anatomical images while monitoring hemodynamic changes, offering excellent visualization of cardiac tissue characteristics and fine structures. With real-time monitoring capabilities, it can promptly detect surgery-related complications, ensuring maximum surgical safety. The launch of this product is expected to reduce clinical treatment costs, benefiting more patients.

Company Profile:

Jiangsu TINGSN Technology Co.,Ltd.Founded in 2019, headquartered in Nanjing, Jiangsu, with research and development centers in both China and the United States. The company focuses on developing globally leadingCardiac Electrophysiology Interventional Surgical Instruments, alreadyEstablish a complete R&D and production team covering transducer development, chip design and processing, bonding process development, ultrasound imaging algorithm development, and ultrasound modeling and navigation algorithm development, forming a closed-loop ecosystem with high technical barriers from the probe, steerable catheter to the mainframe system.

The TINGSN Sonic Eyes 10, which has been approved this time, is the first domestically developed and approved high-end intracardiac echocardiography diagnostic catheter in China.

China's First Intracardiac Ultrasound Catheter Approved for Marketing!

# Transcatheter Mitral Valve Clip System

▲Transcatheter Mitral Valve Clip System（OriginOfficial CompanyNet)

Product Name: Transcatheter Mitral Valve Clip System

Manufacturer: Valgen Medtech Co., Ltd.

Approval Date: 2023/11/29

National Medical Device Registration Certificate: 20233131775

This product consists of two components: a guiding sheath and a mitral clip system. The mitral clip system includes a mitral clip and a delivery system. The elastic central occlusion mesh structure of the mitral clip enhances sealing, reduces central residual regurgitation, and decreases leaflet clamping force. Additionally, the mitral clip features functions such as individual leaflet capture and repositionable grasping, improving operational precision and reducing the risk of clip dislodgement and leaflet perforation.

This product is suitable for patients assessed by the cardiac team as having a high risk of surgery and having mitral valve anatomy that is appropriate.Degenerative Mitral Regurgitation (MR≥3+)Patients. The launch of this product will provide more options for clinical treatment.

Company Overview:

Valgen Medtech Co., Ltd. was founded in 2015 and focuses onInterventional Treatment of Structural Heart DiseaseField. By the end of 2023, the company has cumulatively applied for over 500 patents globally, of which more than 150 have been granted. Three innovative products developed in-house have passed through the special review process for innovative medical devices by the pharmaceutical regulatory authority.

The DragonFly™ Transcatheter Mitral Valve Clip System approved this time, asThe First in ChinaSelf-developed transcatheter venous approach edge-to-edge repair product, receiving support from the "14th Five-Year Plan" National Key Research and Development Program of the Ministry of Science and Technology. The company's currently marketed products also include the Pu Sister™ Medical Radiation Protection Screen, Magpie™ Balloon Dilation Catheter, DragonPath™ Atrial Septal Puncture System, and the Firework™ Rigid Guidewire Series, among other products.

First China-Made Product Approved by NMPA! Transcatheter Mitral Valve Clip System!

# Cryotherapy Ablation Devices and Balloon Catheters

▲Cryogenic Ablation System and Balloon Cryoablation Catheter（OriginOfficial CompanyWebsite)

Product Name:Cryotherapy Ablation Equipment, Balloon Cryoablation Catheter

Manufacturer: Cryofocus Medtech (Shanghai) Co., Ltd.

Approval Date: 2023/12/4

NMPA Registration Certificate:20233011815、20233011816

"Cryotherapy Ablation Equipment" consists of a cryogenic device, vacuum system, low-temperature working fluid delivery circuit, and control system. The "Balloon Cryoablation Catheter" is composed of equipment connection components, operation control components, and blood-contacting components. The two products are used together in medical institutions forTreatment of Drug-Resistant, Recurrent, Symptomatic, Paroxysmal Atrial Fibrillation。

During the treatment process, the "cryoablation device" cools nitrogen through a heat exchanger and delivers it to the balloon's inner cavity, causing the balloon in contact with the tissue to generate low temperatures. The temperature feedback from the catheter dynamically adjusts the pressure and flow of the cryogenic medium to maintain the balloon surface temperature within the specified range. Meanwhile, the vacuum pump of the device continuously extracts air from the outer catheter tube, achieving a highly vacuumed thermal insulation state for the outer tubing, ensuring the safety of non-ablation areas and enhancing the overall surgical safety.

Company Overview:

Cryofocus Medtech (Shanghai) Co., Ltd.(6922.HK) was founded in 2013 and is a leadingCryoablation Minimally Invasive Interventional TreatmentThe company was listed on the Hong Kong Stock Exchange on December 30, 2022.

With its unique liquid nitrogen cryoablation technology, the company is committed to building a comprehensive product portfolio, primarily focusing on two major therapeutic areas: vascular intervention for treating severe cardiovascular diseases such as atrial fibrillation and hypertension; and natural orifice interventions for treating respiratory, urological, and digestive system diseases, such as asthma, chronic obstructive pulmonary disease (COPD) with airway stenosis, bladder cancer, stomach cancer, and esophageal cancer.The company has been deeply engaged in cryoablation technology.Successfully developed multiple innovative cryoablation products.

Just Now! Two Innovative Medical Devices Approved for Marketing!

# Biodegradable Magnesium Metal Clip

▲Biodegradable Magnesium Metal Clip（OriginOfficial CompanyNet)

ProductionProduct Name: Biodegradable Magnesium Metal Clip

Manufacturer:Origin Medtech

Approval Date: 2023/12/13

National Medical Device Registration Certificate: 20233021931

This product consists of a degradable magnesium metal clip and a base. The magnesium metal clip includes three parts: the upper arm, lower arm, and the O-shaped structure at the tail, which is placed inside the base. Among these, the degradable magnesium metal clip is made of...Made of high-purity magnesium material, which can avoid the potential health risks of commonly used elements such as aluminum and rare earths in existing magnesium alloy products to the human body, and does not affect postoperative imaging diagnosis such as X-ray, CT, and MRI after implantation; through plastic deformation and heat treatment technology regulation, the mechanical properties of high-purity magnesium metal are enhanced, improving the stability and reliability of the closure clip.

This product is suitable forLigation and closure of tubular tissues such as blood vessels or bile ducts that do not require permanent occlusion in surgical procedures, not applicable to large arteries and large veins. The product's market launch will provide more options for clinical treatment.

Company Profile:

Origin Medtech was founded in 2010 and is committed toBiodegradable Magnesium Metal Biomaterials and Related Implantable Medical DevicesInnovation and industrialization. The company's technical team comes from Shanghai Jiao Tong University, with over 10 years of research and development experience in medical metal materials.The main products include: disposable ligation clips; laparoscopic trocars and sheaths; rib fixation plates; medical external fixation splints, and tubing products, etc.

The approved biodegradable magnesium metal closure clip in this approval isThe First in ChinaRelying on its self-developed biodegradable magnesium metal material technology platform, Origin Medtech is also researching the clinical applications of this material in various fields such as minimally invasive surgery, orthopedic sports medicine, medical aesthetics, and interventional medicine.

Latest! Another Innovative Medical Device Approved by NMPA

# Single-use Cardiac Pulse Electric Field Ablation Catheter and Cardiac Pulse Electric Field Ablation Instrument

▲Single-Use Cardiac Pulse Electric Field Ablation Catheter and Cardiac Pulse Electric Field Ablation System（OriginOfficial CompanyNet)

Product Name: Single-Use Cardiac Pulse Electric Field Ablation Catheter, Cardiac Pulse Electric Field Ablation Instrument

Manufacturer: Sichuan Jinjiang Electronic Science and Technology Co., Ltd.

Approval Date: 2023/12/26

NMPA Registration No.: 20233012053, 20233012051

The disposable cardiac pulse field ablation catheter consists of a catheter and a connecting cable. The cardiac pulse field ablation instrument is composed of a main unit, an output box, and accessories.China's First Cardiac Pulse Field Ablation Product。

The above two products are used in conjunction to selectively cause irreversible electroporation damage to myocardial cells in the lesion area that requires treatment by controlling and releasing pulsed electric field energy of appropriate intensity, thereby achievingTreatment of Atrial FibrillationThe purpose is toTreatment of Drug-Resistant, Recurrent, Symptomatic, Paroxysmal Atrial FibrillationProvided more options.

Company Overview:

Sichuan Jinjiang Electronic Science and Technology Co.,Ltd. was established in 1991, focusing onDiagnosis and Ablation in Cardiac ElectrophysiologyR&D, Production, and Sales of High-End Innovative Medical Devices, covering products related to electrophysiological surgeries such as magnetic and electric 3D systems, electrophysiological multi-channel recorders, radiofrequency ablation generators, PFA ablation systems, radiofrequency ablation catheters, electrophysiological mapping catheters, needle sheaths, etc., and has established "Mapping System + Treatment Device + Consumables"Complete Solution.

As a pioneer in China's cardiac electrophysiology industry, the company continuously drives technological matrix innovation and product line expansion, establishing simulation verification technology platforms, medical electronics technology platforms, mapping and navigation technology platforms, radiofrequency ablation energy technology platforms, pulsed electric field ablation energy technology platforms, catheter process technology platforms, and system integration technology platforms.Seven Core Technology Platforms, with the capability to independently develop a full range of products for cardiac electrophysiology devices and consumables, and expanding into the pain management field.

Review of 10 Pulsed Field Ablation Companies

Overseas Cardiovascular Devices:

Products of Chinese Cardiovascular Companies: