Full year 2024 (as of December 31),The National Medical Products Administration (NMPA) has approved a total of 35Innovative Medical Devices Related to CardiovascularThis article will review these 35 devices and their respective companies, along with related reports (sorted by approval time).
1. Hangzhou Nuomao Medical Technology Co., Ltd. (1 model)Product Name: Single-Use Cardiac Pulsed Field Ablation CatheterNational Medical Device Registration: 20243010461This product is a single-use catheter for cardiac electrophysiology procedures, which performs ablation of cardiac tissue through pulsed electric fields to treat arrhythmias. It provides a non-thermal ablation method aimed at reducing the risk of damage to surrounding tissues and is suitable for patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.Hangzhou Nuomao Medical Technology Co., Ltd. (formerly "Noya Medical") was established in 2016 as a company incubated by DNM. It is an innovative medical enterprise dedicated to the research, development, manufacturing, sales, and technical support of interventional medical devices for atrial fibrillation electrophysiology and stroke prevention. The company's main products include electrophysiological devices such as pulsed field ablation for atrial fibrillation and stroke prevention devices like left atrial appendage closure devices.Nuomao's CardiPulse® Single-Use Cardiac Pulse Field Ablation Catheter and Cardiac Pulse Field Ablation SystemChina's First Approved Petal-Shaped Pulsed Field Ablation System with Full Independent Intellectual Property RightsThe system ablates myocardial tissue in a non-thermal manner, with tissue specificity, ablating myocardial tissue while preserving surrounding tissue structures, avoiding conductive thermal injury and barotrauma.2. magAssist (Suzhou) Co., Ltd. (2 products)Product Name: Extracorporeal Ventricular Assist DeviceExtracorporeal Ventricular Assist Pump Head and TubingNMPA Registration: 20243100773These two products are key components of the extracorporeal ventricular assist system, providing temporary cardiac support during heart surgery. Extracorporeal ventricular assist devices can aid or replace heart function during cardiac surgery, while the pump head and tubing are essential parts of the system, ensuring blood flow and proper operation of the equipment.Since its establishment in 2017, magAssist has invested hundreds of millions of RMB in research and development. Dr. Xu Boting, the founder, has collaborated with numerous top R&D talents from China and abroad to build a complete life support equipment R&D and manufacturing team. magAssist is also committed to creating a multi-organ life support platform. Based on the product’s full magnetic levitation centrifugal pump technology platform, it has developed the latest generation of Extracorporeal Membrane Oxygenation System (ECMO). Based on the same control platform,StrikeDeveloped the world's smallest minimally invasive artificial heart, and became the only artificial heart product to achieve "dual innovation" in both China and the US.。Currently, magAssist has developed three product lines, which have achieved full coverage of non-endpoint treatment for heart failure, the widest range of indications, and multi-scenario, multi-age group applications. The company has submitted over 300 patent applications, initially establishing a strong competitive edge in the independent research and development of high-end life support equipment.3. Medtronic, Inc. (4 models)Product Name: Disposable Multi-Polar Renal Artery Radiofrequency Ablation CatheterRenal Artery Radiofrequency Ablation Device Cardiac Pulsed Field Ablation SystemSingle-Use Cardiac Pulsed Field Ablation CatheterRegistration No.: 20243010242MedtronicDisposable Multi-Polar Renal Artery Radiofrequency Ablation Catheter and Renal Artery Radiofrequency Ablation InstrumentUsed forTreatment of Hypertension, especially for patients who do not respond to drug therapy. The disposable multi-pole renal artery radiofrequency ablation catheter ablates the tissue surrounding the renal artery through the transmission of radiofrequency energy, while the renal artery radiofrequency ablation generator is the device that provides this energy; both are used together to achieve the therapeutic effect.。The other two products are used together, based on the non-thermal effects principle of pulsed electric fields.Treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation(Seizure duration less than 1 year). Compared with traditional radiofrequency ablation and cryoablation products, this product can achieve selective destruction of myocardial tissue, avoiding the risk of surrounding tissue damage caused by temperature conduction.Medtronic, Inc. is a global leader in medical technology, offering a wide range of medical solutions, including cardiology and vascular, minimally invasive therapies, restorative therapies, and diabetes management. The company is committed to improving the health and quality of life for patients worldwide. Its main product lines are divided into four major businesses: cardiovascular, surgical and critical care, neuroscience, and diabetes, covering products and service systems in the treatment areas of arrhythmia, heart failure, cardiac intervention, heart valve replacement, diabetes, gastrointestinal diseases, urological diseases, spinal diseases, neurological disorders, and ENT.4. Shanghai Tendfo Medical Technologies Co., Ltd. (1 model)Product Name: Pulmonary Artery Thrombectomy Stent SystemNMPA Registration: 20243031010Pulmonary Artery Thrombectomy Stent System is a device used forTreatment of Acute Pulmonary EmbolismMedical device. The system, through stent and thrombectomy technology, can effectively remove blood clots blocking the pulmonary artery, restore blood flow, and is an emergency medical intervention that saves patients' lives.Shanghai Tendfo Medical Technologies Co., Ltd. focuses on the field of cardiovascular and peripheral vascular interventional therapy, committed to developing and producing high-quality medical devices. With innovation and quality at its core, the company provides effective treatment solutions for doctors and patients.5. Hangzhou Noya Medtech Co., Ltd. (1 model)Product Name: Single-Use Radiofrequency Atrial Septal Puncture NeedleNMPA Registration No.: 20243011095This product is a puncture tool used in cardiac electrophysiology procedures.Puncture the atrial septum through radiofrequency energy., in order to perform further diagnostic or therapeutic procedures. It provides a precise and safe puncture method, helping to reduce surgical risks and complications.Hangzhou Noya Medtech Co., Ltd. was founded in 2017, incubated by Nuomao, and is committed to providing new treatment solutions for heart failure patients worldwide. The company's main product, the NoYA(TM) Radiofrequency Interatrial Shunt System, is the world’s first non-implantable device for interatrial shunting, ushering in a new era of non-implant catheter-based treatments for heart disease and filling the gap in heart failure treatment, especially for Heart Failure with Preserved Ejection Fraction (HFpEF).6. Artechmed (2 products)Product Name: Cryoablation System
Balloon Cryoablation CatheterNational Medical Device Registration: 20243011210The cryoablation system developed by Artechmed (Shanghai Artechmed Medical Technology Co., Ltd.) is a device used to treat adult patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The product features"Adjustable Cooling Capacity" and "Rewarming Reminder"Technology that can monitor cryogenic temperatures in real time, reducing damage to adjacent tissues and lowering clinical and operational risks while ensuring therapeutic efficacy.Artechmed is committed to developing and producing advanced cryotherapy devices for the treatment of heart and other related fields. With the goal of improving treatment outcomes and patient comfort, the company continuously drives technological advancements. The innovative medical device independently developed by Artechmed has been approved for marketing, showcasing the company’s professional capabilities in the field of cryotherapy.7.FARAPULSE, Inc. (3 models)Product Name:Single-Use Cardiac Pulsed Field Ablation CatheterCardiac Pulsed Field Ablation System Disposable Adjustable Catheter SheathNational Medical Device Registration (Import):20243010355The single-use cardiac pulsed field ablation catheter and cardiac pulsed field ablation system of FARAPULSE, Inc. is an innovative product used for treating drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The productTreatment of Atrial Fibrillation Using the Non-Thermal Effects of Pulsed Electric Fields, enabling selective destruction of myocardial tissue while avoiding the risk of damage to surrounding tissues caused by heat transfer.A disposable adjustable bending catheter sheath is a type of catheter used in cardiac electrophysiology procedures. Its adjustable bending feature allows the catheter to better adapt to the anatomical structure of the heart, enhancing the flexibility and safety of the procedure.。FARAPULSE, Inc. is an innovative company focused on the field of cardiac electrophysiology, dedicated to developing pulsed field ablation technology. It was acquired by Boston Scientific in 2021. The company's products and services aim to provide safer and more effective treatment options for patients with heart disease. The FARAPULSE PFA System, the world's first approved pulsed field ablation product in the field of arrhythmia, has previously received approval in Europe and the United States, and to date, has treated over 70,000 patients globally.8. Hangzhou Wei Qiang Medical Technology Co., Ltd. (1 model)Product Name: Iliac Vein Stent SystemChina Medical Device Registration: 20243131244Grency®The iliac vein stent system isSpecifically Designed for Iliac VeinsWith an oblique opening design to avoid affecting the blood flow on the opposite side, a flared proximal end for enhanced wall apposition, and a tapered body to accommodate the natural tapering of the vessel. The hybrid structure features closed loops at both ends and an open loop in the middle, balancing support and flexibility. The stent can be retracted and redeployed within 2 cm after initial release.。Hangzhou Wei Qiang Medical Technology Co., Ltd. was established in May 2016 and is located in the Hangzhou National High-tech Industrial Development Zone. It focuses on the research, development, manufacturing, sales, and technical support of peripheral vascular interventional medical devices. Its main products include aortic series, venous series, lower limb products, catheters, and balloons.9. Sonosemi Medical Co., Ltd. (1 model)Product Name: Single-Use Intracardiac Ultrasound Imaging CatheterNational Medical Device Registration: 20243061274This product is mainly used for ultrasound imaging of cardiac structure and function, providing real-time internal images of the heart to assist doctors in making accurate diagnoses and treatments.Sonosemi Medical Co., Ltd. was founded in April 2020 and is a high-tech enterprise focused on active vascular implant and interventional medical devices. Its main products include active interventional high-value medical consumables such as shockwave balloon catheters and ultrasonic catheters, covering clinical application scenarios such as coronary artery disease and peripheral vascular disease.10. Shanghai MicroPort Medical (Group) Co., Ltd. (1 model)Product Name: Bioabsorbable Rapamycin-Eluting Coronary Stent SystemNMPA Registration: 20243131356The Bioabsorbable Rapamycin-Eluting Coronary Stent System is a new type of coronary stent that can be gradually absorbed by the body after treatment, reducing the long-term presence of foreign objects while providing effective drug therapy.Shanghai MicroPort Medical (Group) Co., Ltd. was established in May 1998 and is a leading developer, manufacturer, and marketer of medical devices in China, primarily focusing on minimally invasive interventional products for treating vascular diseases and conditions.Product Name: Renal Artery Radiofrequency Ablation InstrumentDisposable Renal Artery Radiofrequency Ablation CatheterNational Medical Device Registration: 20243011383Renal Artery Radiofrequency Ablation Device for Hypertension TreatmentSyMap is an innovative medical device research company established in Suzhou Biobay, focusing on developing ablation catheters with precise renal nerve function mapping and accompanying radiofrequency ablation systems for the treatment of hypertension and related cardiovascular diseases.Product Name: Renal Artery Radiofrequency Ablation SystemDisposable Mesh Renal Artery Radiofrequency Ablation CatheterNMPA Registration: 20243011387Renal Artery Radiofrequency Ablation Device for Hypertension Treatment: Utilizes radiofrequency energy delivery to ablate tissue surrounding the renal arteries, aiming to achieve a blood pressure-lowering effect.BRATTEA is a high-tech enterprise specializing in interventional treatment for hypertension and cancer pain. It has a professional technical team dedicated to the research and development of cardiovascular interventional medical devices and maintains close cooperative relationships with globally renowned medical experts, universities, and hospitals.13. Shanghai NewMed Medical Co., Ltd. (1 product)Product Name: Transcatheter Aortic Valve SystemNMPA Registration No.: 20243131459Transcatheter Aortic Valve System is a medical device used to treat aortic valve disease. It restores valve function by implanting an artificial valve into the diseased aortic valve position through a catheter. The product isChina's First Balloon-Expandable Transcatheter Aortic Valve, applicable to patients diagnosed with symptomatic, calcified, severe degenerative native aortic valve stenosis after assessment by the cardiac team in conjunction with a scoring system.Shanghai NewMed Medical Co., Ltd. was founded in 2015. It is a high-end medical device enterprise with independent intellectual property rights, focusing on the research and development and industrialization of internationally advanced interventional artificial heart valve devices.14. Shanghai Bluevascular MedTech Co., Ltd. (1 product)Product Name: Venous Stent SystemNational Medical Device Registration: 20243131528Vflower® Venous Stent System isThe first product of Bluevascular MedTech™ in the venous vascular fieldThe design and manufacture of the product fully utilize the long-established technical platform of HeartCare in vascular stent and delivery system manufacturing, with an in-depth study of the morphological characteristics and hemodynamics of venous vessels. This venous stent system is used to treat venous stenosis or occlusive diseases by implanting stents to restore vascular patency, alleviate symptoms, and improve patients' quality of life.Shanghai Bluevascular MedTech Co., Ltd. is a subsidiary of Shanghai MicroPort Cardiomed Medical Technology (Group) Co., Ltd., mainly engaged in peripheral venous business.15. Beijing Balance Medical Technology Co., Ltd. (1 model)Product Name: Transcatheter Aortic Valve SystemNational Medical Device Registration: 20243131529The transcatheter aortic valve system is a medical device used to treat aortic valve disease. It restores valve function by implanting an artificial valve into the diseased aortic valve position via a catheter. The productPioneering the achievement of a leaflet opening and closing mode consistent with surgical bioprosthetic valves., in order to overcome clinical concerns about the durability of traditional transcatheter valve products.Beijing Balance Medical Technology Co., Ltd. was established in 2005 as a high-tech enterprise dedicated to the research, development, and production of high-value animal-derived implantable medical devices. The company independently develops animal tissue engineering and original chemical modification technologies. It has currently received approval for 17 Class III medical device products, covering three major fields: heart valve replacement and repair, congenital heart disease implantation and intervention treatment, and surgical soft tissue repair.16.Boston Scientific Corporation (2 products)Product Name: Vascular Plaque Rotablation Control DevicePeripheral Plaque Excision Catheter for Single UseNMPA Registration: 20243010448These two products are comprehensive solutions for peripheral vascular diseases.Innovative design combining rotational cutting with active suction, achieving plaque removal and active suction-perfusion function. Blood vesselPlaque Atherectomy Control Device is used for the atherectomy treatment of atherosclerotic plaque, helping to remove diseased plaque within blood vessels and restore vascular patency. The single-use peripheral vascular plaque atherectomy catheter is used in conjunction with the control device, being lightweight, flexible, precisely targeting the diseased plaque, and safely removing it, making it suitable for clinical procedures.Boston Scientific, founded in 1979 and headquartered in Massachusetts, USA, is one of the world's leading minimally invasive medical technology companies. The company’s products are widely used in multiple fields such as cardiovascular, peripheral vascular, endoscopic therapy, neuromodulation, and urology, aiming to improve patient outcomes and quality of life through technological innovation.In the field of vascular interventional therapy, Boston Scientific offers a variety of innovative devices, including solutions for atherectomy, stent placement, and balloon dilation. Its superior technology, product quality, and clinical performance have earned the trust of medical institutions worldwide.17. Shanghai HeartCare Medical Technology Co., Ltd. (1 model)Product Name:Intracranial Aneurysm Embolization Assist StentApproval Date: 2024/10/31China Medical Device Registration Certificate No. 20243132152This product consists of three parts: a stent, a delivery guidewire, and an introducer sheath. The stent is made from a nickel-titanium alloy tube through laser engraving, with platinum-iridium markers at both ends and in the middle section of some models to facilitate precise clinical assessment of stent deployment and wall apposition. Under standard interventional surgical conditions, the location of intracranial aneurysms is determined using angiography.UseFor Intracranial Aneurysm Patients: Endovascular Adjunctive Embolization and Blood Flow Reconstruction。
Shanghai HeartCare Medical Technology Co., Ltd. (Stock Code: 06609.HK) was founded in 2016.Operations include multiple emerging business segments such as neurointervention, full-heart treatment, and peripheral intervention. The company has 30 products on the market and has applied for more than 300 patents. Its products are used in over 1,500 hospitals in China. Several neurointerventional products, including thrombectomy stents, distal access catheters, and left atrial appendage closure devices, ranked first in their respective categories in the VBP (Volume-based Procurement) program.18. Microport Sorin Crm(Shanghai)Co.,Ltd. (1 model)Product Name: Implantable Cardiac Pacemaker LeadApproval Date: 2024/11/21NMPA Registration No.: 20243122320This product is one of the core components of a pacemaker, used to connect the pacemaker and the heart, transmit pacing signals, and help control heart rhythm. The electrode lead is designed to be soft and durable, capable of adapting to the complex anatomical structure of the heart, and is suitable for treating arrhythmias such as conduction block.Microport Sorin Crm(Shanghai)Co.,Ltd. is a Chinese domestic medical device company that focuses on the research, development, and production of cardiac rhythm management devices. The company’s product portfolio includes implantable pacemakers, leads, and more, with a commitment to providing patients with high-quality, safe, and efficient cardiac rhythm management solutions through technological innovation.19. Hangzhou Ruidi Biotechnology Co., Ltd. (2 products)Product Name: Single-Use Steep Pulse Ablation NeedleSteep Pulse Treatment DeviceApproval Date: 2024/11/27NMPA Registration No.: 20243092384These two products are arrhythmia treatment systems based on high-frequency pulsed ablation technology.The Disposable Steep Pulse Ablation Needle is a single-use ablation needle for cardiac interventional procedures, capable of precisely destroying abnormal tissues while protecting the surrounding healthy tissues, thereby enhancing treatment outcomes.The陡脉冲治疗设备 is a high-frequency pulse ablation instrument配套 with ablation needles, capable of precisely controlling pulse energy and frequency.Hangzhou Ruidi Biotechnology Co., Ltd. is an innovative enterprise focused on the research and development of cardiovascular interventional treatment equipment. With "precision medicine" at its core, the company is committed to developing high-end medical devices, particularly in the field of pulsed electric field ablation.Through continuous technological innovation and clinical practice, we provide patients with efficient and safe treatment solutions.20. Shanghai Hong Tong Industries Inc. Co., Ltd. (1 model)Product Name:Cardiac Pulsed Field Ablation SystemApproval Date: 2024/12/13CN Medical Device Registration Certificate 20243012477This product adopts pulsed electric field ablation technology, selectively treating tissue at the lesion site by controlling pulsed electric field energy, causing irreversible electroporation damage to myocardial cells, thereby achieving the therapeutic purpose. This technology can effectively reduce the risk of thermal injury to surrounding normal tissues, benefiting more patients with drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.Shanghai Hong Tong Industries Inc. Co., Ltd. was established in 1998, with its registered address located in Qingpu District. It is a high-tech enterprise specializing in the research, development, and manufacturing of equipment related to high-value consumables for cardiovascular and cerebrovascular interventions.Currently a wholly-owned subsidiary of Huitai Medical (688617), it undertakes the development tasks of the group's active medical electronic equipment, focusing on the domestic substitution of high-end cardiac electrophysiology diagnostic and treatment equipment. In the future, it will serve the group’s globalization strategy in the high-value cardiovascular consumables sector.21. Shanghai Changdy Medical Co., Ltd. (1 model)Product Name:Artificial Blood VesselApproval Date: 2024/12/16China Medical Device Registration Certificate No. 20243132518CIRCULINE®It is made by the organic combination of medical-grade high-elasticity silicone and expanded polytetrafluoroethylene.Textile-based Artificial Vessel, featuring a three-layer structure consisting of inner, middle, and outer layers. The inner layer is an ultra-thin expanded polytetrafluoroethylene (ePTFE) vascular graft with a high molecular support ring, offering excellent biocompatibility and providing a good anti-thrombotic channel for blood flow; the middle layer is made of medical-grade highly elastic silicone, which has the property of quickly returning to its original shape after deformation, providing optimal needle hole closure performance after dialysis puncture; the outer layer is a polyester braided vascular graft with excellent suture ability, offering speed and the required suture strength for intraoperative anastomosis suturing.Jiangsu Baiyouda Life Technology Co., Ltd. was established in 2015 and currently has two production and R&D bases in Nantong and Shanghai.Focused on the R&D and production of high-end implantable and interventional medical devices, wholly-owned subsidiaries Changdi and Baheya were established successively. Under its umbrella is VASOLINE.®Artificial Vessel, VASOPATH®Products such as disposable strap retractors, MONOKNIT hernia repair patches, and VASO non-absorbable surgical sutures have been launched.22. Lifetech Scientific（Shenzhen）Co.,LTD. (1 model)Product Name:Aortic Membrane Stent Rupture SystemApproval Date: 2024/12/16CN Medical Device Registration No. 20243032519
This product is a puncture tool for in-situ fenestration technology within the body, used in conjunction with the company's verified aortic arch main stent system. It is suitable for treating Stanford Type B dissection patients who require reconstruction of blood flow in the left subclavian artery and is used for in-situ fenestration of the stent within the body.Lifetech Scientific (Stock Code: 1302.HK) was founded in Shenzhen, China in 1999, focusing onResearch, Production, and Global Development of Cardiovascular, Cerebrovascular, and Peripheral Vascular Interventional Medical Devices, continuously expanding business areas and achieving technological breakthroughs. As of December 31, 2023, the company has achieved a high-quality patent layout of more than 2,100 items, with a cumulative total of 15 products approved by the National Medical Products Administration (NMPA) to enter the "Special Review Procedure for Innovative Medical Devices."23. Shanghai MicroPort Melody Medical Technology Co., Ltd. (2 products)Product Name: Rotablation Interventional Therapy SystemDisposable Coronary Rotablator CatheterApproval Date: 2024/12/17NMPA Registration: 20243012607The rotational atherectomy system consists of a main unit and a power cord. The disposable coronary rotational atherectomy catheter is composed of a rotational atherectomy catheter and a rotational atherectomy advancer, both of which are used in conjunction.Mainly used for the pretreatment of severe calcified lesions in primary coronary arteries.This product is a domestic innovation in China, adopting variable-diameter bidirectional rotational grinding technology. It utilizes an eccentric grinding head structure to adjust the centrifugal force by changing the rotation speed, thereby controlling the grinding diameter. This reduces the need for instrument switching during procedures, aiming to minimize interventional trauma and enhance lumen modification effects, effectively improving the success rate of vascular interventional treatments for patients.
Shanghai MicroPort Melody Medical Technology Co., Ltd., a subsidiary of MicroPort Medical Group, is one of the leading enterprises in the field of cardiovascular interventional therapy in China. The company focuses on the research, development, and production of high-end interventional medical devices, including coronary intervention treatment equipment and peripheral vascular intervention devices.Its product performance and safety reach international advanced levels, not only widely used in the domestic market but also exported to multiple countries and regions overseas, serving as an important force in promoting China's medical technology onto the global stage.24. APT Medical Inc. (1 model)Product: Single-Use Magnetic and Electrical Positioning Pressure Monitoring Pulsed Electric Field Ablation CatheterApproval Date: 2024/12/17National Medical Device Registration: 20243012609This catheter is a high-end ablation device that combines magnetic and electrical positioning with pressure monitoring technology. It is used in conjunction with a pulsed electric field ablation instrument and is suitable for the precise treatment of complex arrhythmias. The catheter can provide real-time position and pressure feedback, helping doctors optimize surgical procedures and improve treatment outcomes.APT Medical Inc., affiliated with Huitai Medical, was established in 2006. It is a high-tech enterprise specializing in the research, development, production, and sales of cardiac electrophysiology and interventional medical devices. The company has formed a business layout dominated by a complete coronary pathway and cardiac electrophysiology medical devices, with peripheral vascular and neurointerventional medical devices as key development directions.
# Global Leading Cardiovascular Device CompanyMedtronic｜J&J MedTech|Boston ScientificBoston Scientific|
Edwards Lifesciences | AbbottAbbott｜
# Chinese Listed Cardiovascular Device Companies
# Innovative Devices Approved in China in 2023#2023 China Innovative Medical Devices Entering the Fast TrackmagAssist (NyokAssist Interventional Ventricular Assist System)
NorthX Life (Cardiac Pulse Field Ablation)
Hanling Medical (Transcatheter Aortic Valve)
# Other Unlisted/Startup Cardiovascular Companies
Artivion| HVR Cardio | CardiacSense | Lydus Medical | Volta Medical |Cardiac Dimensions
