Cardiovascular Device Sector Monthly Highlights: 3 Financing & M&A Deals, 9 Product Approvals, and Key Clinical Advances | Heart Future Report July 2025

Aug 04, 2025 17:07 CST Updated 17:07

Field Medical

Developer of Pulsed Electric Field Catheter Ablation Technology

Acutus Medical

Intracardiac Imaging System Device Developer

Johnson & Johnson

Medical Device R&D and Manufacturer

Heart Future

In July 2025, the cardiovascular device industry continues to evolve at a high frequency: from cross-border mergers and acquisitions to hundreds of millions of dollars in financing, from the accelerated implementation of innovative devices to breakthroughs in clinical data, every piece of news reflects the next direction of the industry.

The intertwining forces of capital, regulation, and clinical practice are driving a rapid reshaping of the technological landscape:Non-contact MappingAndPFA Ablation AccelerationFrom "Concept" to "Standard",Structural Heart Disease Interventional DevicesWitness密集获批,Peripheral Intervention、Pulmonary Artery TreatmentNew signals have also emerged in more specific fields.

This issue of "Heart Future" monthly report will take you through the key industry events of July:

M&A Financing: EnChannel Medical Acquires Core Assets of Acutus Medical, Advancing Non-Contact Mapping Towards Clinical Application; Field Medical Completes $250 Million Series B Financing, Accelerating PFA Ablation Clinical Progress; Versa Vascular Oversubscribed with $200 Million, Heating Up the Tricuspid Valve Intervention Sector.
Product Approval: From China-produced V-shaped left atrial appendage closure system to the world's first robot-navigated high-density mapping catheter, 9 products have been approved, providing more options for clinical use.
Innovative Progress: Multiple breakthroughs in transcatheter ventricular septal radiofrequency ablation, PFA technology, and artificial blood vessels are reshaping treatment pathways.
Earnings Signal: Johnson & Johnson, Edwards, and MicroPort EP's strong performance exceeded expectations, reflecting the high prosperity and future growth momentum of the global cardiovascular market.

For medical device companies, these changes mean a reshuffling of market opportunities and competitive landscape; for clinicians, it is not only an update in products and technology but also a continuous expansion in diagnostic and treatment options as well as evidence-based pathways. Every event in July serves as a key footnote to understanding future industry trends.

Time: 2025.7.1—2025.7.31

# M&A Financing (3 cases)

｜Cross-border Acquisition: Boosting Non-contact Mapping Technology

EnChannel Medical Announces Completion of Acquisition of Core Assets of AcQMap™ High-Resolution Imaging and Mapping Platform from Acutus MedicalThis acquisition covers intellectual property, technical documentation, clinical data, and equipment, marking a new phase of integration for non-contact mapping technology and is expected to reshape the competitive landscape of complex arrhythmia mapping technology. As an emerging electrophysiological mapping technology, non-contact mapping offers higher efficiency and precision compared to traditional contact mapping, enabling faster construction of 3D cardiac models and more accurate localization of lesions, providing stronger support for the treatment of complex arrhythmias.

EnChannel Medical Accelerates Its Technological Layout in the Electrophysiology Field Through This Acquisition, Promoting the Clinical Application and Market of Non-Contact Mapping TechnologyPromotion,Further enhance its competitiveness in the global cardiovascular device market.

｜$250 Million Series B: Pulsed Field Ablation System

Field Medical Announces Completion of $35 Million (Approx. RMB 250 Million) Series B FinancingThe company focuses on pulsed field ablation (PFA) technology, and its core productFieldForce™ Ablation SystemFor the ablation treatment of ventricular tachycardia (VT). This round of financing will advance the VERITAS pivotal clinical trial, supporting the company’s development in the PFA field. Pulsed Field Ablation (PFA) technology, as an emerging ablation technology, offers advantages such as high tissue selectivity, high ablation efficiency, and fewer complications, and is considered one of the key future directions in cardiac ablation therapy.

Field Medical Completes This Round of Financing, will accelerate the research and development and clinical trial process of its FieldForce™ ablation system, promoting the technology on a global scale.The application and promotion within China are expected to provide more effective solutions for the treatment of complex arrhythmias such as ventricular tachycardia.

｜200 Million Oversubscription: Transcatheter Tricuspid Valve Repair System

Versa Vascular, a startup focused on structural heart disease treatment, announced the completion of an oversubscribed financing round, raising a total of $27.3 million (approximately RMB 200 million).This round of financing was led by Santa Cruz Ventures, marking Versa VascularOfficially Step Out of the "Stealth" Phase, committed to transforming the treatment landscape for tricuspid regurgitation with an innovative transcatheter tricuspid valve repair system. Tricuspid regurgitation is a common type of structural heart disease, and traditional treatment methods have certain limitations. Versa Vascular's transcatheter tricuspid valve repair system, as an innovative minimally invasive treatment technology, offers advantages such as minimal trauma, rapid recovery, and excellent outcomes, and is expected to provide a safer and more effective treatment option for patients with tricuspid regurgitation.

This oversubscriptionFinancingWill provide sufficient financial support for Versa Vascular's R&D and clinical trials, accelerating the market launch of its products.

# Product Approvals (9 Products)

｜Made in ChinaV-shaped Left Atrial Appendage Closure System Approved for Marketing

V-Clip Left Atrial Appendage Closure System by Beijing Leadline Medical Technology Co., Ltd. (referred to as "Leadline Medical")^®Approved for marketing by the NMPA.The system isThe World's 3rd Approved Left Atrial Appendage Closure Device with One End Open, with good tissue compliance and operational convenience, can significantly reduce the risk of stroke.

Left Atrial Appendage Closure as an Important Method for Preventing Stroke in Patients with Atrial Fibrillation has Received Increasing Attention in Recent Years.

V-Clip^®The approval of the system brings a new option to the left atrial appendage closure market in China. Its unique V-shaped design and excellent tissue compliance can better adapt to the left atrial appendage anatomy of different patients, improving the success rate and safety of the surgery. It is expected to provide a higher quality treatment solution for a wide range of patients with atrial fibrillation.

｜China-Made Recyclable TAVR Delivery System Receives CE Approval

Blue Sail Medical's IMPERIA™ Delivery System Receives EU CE Certification for Use with the ALLEGRA™ Series of Aortic Valves.The system features a stable and reliable retrievable design with excellent vascular passability, which is expected to drive new breakthroughs in the commercialization of the TAVR system.

Transcatheter Aortic Valve Replacement (TAVR), as a minimally invasive heart valve replacement technology, has been widely applied globally in recent years.

The approval of the IMPERIA™ Delivery System for CE certification marks that Blue Sail Medical's technical strength in the TAVR field has gained international recognition. Its retrievable design can effectively reduce surgical risks, enhancing the safety and success rate of the procedure, offering a new treatment option for patients with aortic valve disease in Europe and globally. This further advances the commercialization process of TAVR technology.

｜Boston Scientific PFA System Approved for New Indications

Boston Scientific's FARAPULSE Pulsed Field Ablation System Receives FDA Approval for Treating Patients with Drug-Refractory, Symptomatic Persistent Atrial Fibrillation.Previously approved in many regions globally, the new indication further expands its application scope.

Pulsed Field Ablation Technology, as an emerging ablation technology, has received widespread attention in the field of cardiac electrophysiology in recent years.

The approval of this new indication for the FARAPULSE system not only provides more treatment options for patients with persistent atrial fibrillation but also further solidifies Boston Scientific's leading position in the pulsed field ablation domain, promoting the application and adoption of this technology on a global scale, with the potential to bring benefits to more patients with atrial fibrillation.

｜China-Made Peripheral Vascular Intravascular Ultrasound Catheter Approved for Marketing

Shenzhen Northcore Life Technology Co., Ltd. ("Northcore Life") TrueVision 18™ Peripheral IVUS Catheter Receives NMPA Approval for Market Launch.The product operates at 30MHz.World's Highest Resolution、10mm/s Fastest Withdrawal SpeedAdvantages such as breaking the monopoly of imported products and assisting in precise peripheral vascular intervention.

Intravascular Ultrasound (IVUS) in Peripheral Vessels: An Important Intravascular Imaging Technique for the Diagnosis and Treatment of Peripheral Vascular Diseases

The approval and market launch of the TrueVision 18™ Peripheral IVUS Catheter marks a significant breakthrough in the field of peripheral intravascular ultrasound in China. Its high resolution and fast pullback speed can provide doctors with clearer and more accurate intravascular images, improving the success rate and safety of peripheral vascular interventional procedures. It breaks the monopoly of imported products in the domestic market and offers Chinese patients a higher quality and more economical treatment option.

｜Johnson & Johnson PFA Platform Perfusion Flow Rate Update Receives FDA Approval

Johnson & Johnson Medical Technologies announced that the latest optimization of its VARIPULSE™ platform for perfusion flow rate has received FDA approval in the United States.This move marks another milestone for Johnson & Johnson in the pulsed field ablation (PFA) domain, while demonstrating its data-driven, clinically practical technological innovation strategy.

Pulsed Field Ablation Technology, as an emerging ablation technology, has received widespread attention in the field of cardiac electrophysiology in recent years.

The approval of this update to Johnson & Johnson's VARIPULSE™ platform not only further enhances the technical performance and clinical application value of the platform but also reflects Johnson & Johnson's continuous investment in technological innovation and its R&D philosophy guided by clinical needs. This is expected to provide stronger support for the clinical application and promotion of pulsed field ablation technology.

｜World's First Drug-Coated Balloon for Vertebral Artery Approved for Marketing

Beijing Cercare Medical Technology Co., Ltd. (referred to as "Cercare") AcoArt Verbena, the world's first paclitaxel-coated balloon dilation catheter for vertebral artery.^®Approved for marketing by NMPA.This product inhibits intimal hyperplasia by locally releasing paclitaxel, achieving "intervention without implantation."

Vertebral artery stenosis is a common peripheral vascular disease, and traditional treatment methods have certain limitations.

AcoArt Verbena^®The approval and market launch provide a brand-new option for the treatment of vertebral artery stenosis. Its drug-coated balloon can effectively inhibit intimal hyperplasia, reduce the occurrence of restenosis, and at the same time avoid the long-term risks and complications that may be caused by stent implantation, achieving “Intervention without implantation" The treatment concept is expected to bring safer and more effective treatment options to a wide range of patients with vertebral artery stenosis.

｜China's First Controllable Bend Microcatheter Approved for Marketing

Huanxin Medical Technology (Suzhou) Co., Ltd. (referred to as "Huanxin Medical") SteerFar Curve Tour^®Controllable Bend Microcatheter Receives NMPA Approval for Marketing.This product features a bidirectional 180° dynamic bending function, allowing for precise adaptation to complex vascular morphologies, enhancing the accuracy and safety of surgical procedures.

Microcatheters play a crucial role in cardiovascular interventional procedures, with their maneuverability and flexibility being vital to the success and safety of the surgery.

SteerFar QiuYou^®The approval and market launch of the controllable bend microcatheter marks an important breakthrough in China in the field of microcatheters. Its bidirectional 180° dynamic bending function can better adapt to the anatomical structure of complex blood vessels, improving the precision and safety of surgeries, and providing higher quality and more reliable instrument support for cardiovascular interventional procedures in China.

｜World's First Robotic Navigation Mapping Catheter Receives FDA Approval

Stereotaxis, a leader in robotic navigation for interventional procedures, announced that its self-developed MAGiC Sweep catheter, the world’s first robotically navigated high-density cardiac electrophysiology mapping catheter, has received FDA 510(k) clearance.This catheter integrates 20 high-precision electrodes, enabling rapid and accurate cardiac electrophysiological mapping, significantly enhancing the efficiency and effectiveness of arrhythmia treatment.

The integration of robotic navigation technology with cardiac electrophysiological mapping has become an important development direction in the cardiovascular field in recent years.

The approval of the MAGiC Sweep catheter marks a new phase in robotic navigation cardiac electrophysiological mapping technology. Its high-precision electrodes and robotic navigation capabilities provide doctors with clearer and more accurate cardiac electrophysiological information, improving the efficiency and effectiveness of arrhythmia diagnosis and treatment, and offering stronger support for the treatment of complex arrhythmias.

｜China-Made Pulmonary Artery Thrombectomy Stent Approved for Marketing

Beijing Guanqiao Medical Technology Co., Ltd. (referred to as "Guanqiao Medical")'s Ruifan^®Pulmonary Artery Thrombectomy Stent System Officially Approved by NMPA for Registration.The approval of this innovative product not only greatly enriches the product pipeline of EnChannel Medical but also brings more treatment options for patients with acute pulmonary embolism, marking a new breakthrough in the field of pulmonary vascular interventional therapy in China.

Acute pulmonary embolism is a serious pulmonary vascular disease, and traditional treatment methods have certain limitations.

EnChannel Medical^®The approval and market launch of the pulmonary artery thrombectomy stent system provides a novel treatment option for acute pulmonary embolism. Its innovative stent design effectively removes thrombi from the pulmonary arteries, restores pulmonary blood flow, improves patient survival rates and quality of life, and further advances the development of China's pulmonary vascular interventional therapy field.

# Innovative Devices (3 models)

｜Transcatheter Intramyocardial Septal Radiofrequency Ablation Enters Innovation Pathway

Suzhou SinoScience Medical Technology Co., Ltd. (referred to as "SinoScience Medical") Transcatheter Intramyocardial Septal Radiofrequency Ablation System enters the innovation channel for the treatment of obstructive hypertrophic cardiomyopathy.This technology was pioneered by Professor Liu Liwen's team from Xijing Hospital, offering advantages such as minimal invasiveness and low risk of complications.

Obstructive hypertrophic cardiomyopathy is a common hereditary cardiovascular disease, and traditional treatment methods have certain limitations and risks.

Cainas Medical's Transcatheter Intramyocardial Radiofrequency Ablation System for Ventricular Septum, as an innovative minimally invasive treatment technology, delivers radiofrequency energy precisely to the ventricular septal myocardium through a transcatheter approach, achieving ablation of hypertrophic myocardium, thereby relieving left ventricular outflow tract obstruction and improving patient symptoms. The system’s entry into the innovation pathway marks a significant breakthrough in China’s treatment of obstructive hypertrophic cardiomyopathy, offering the potential for a safer and more effective treatment option for patients.

｜Pulsed Field Ablation System Enters Innovation Pathway

EnChannel Medical's Pulsed Electric Field Ablation System Enters Innovation Pathway.The company relies onWorld's First 4D Mapping System and PFA Technology, focusing on the challenges of atrial fibrillation treatment, its product portfolio is expected to achieve personalized ablation for persistent atrial fibrillation.

Pulsed Field Ablation Technology as an Emerging Ablation Technique Has Received Widespread Attention in the Field of Cardiac Electrophysiology in Recent Years.

EnChannel Medical's pulsed electric field ablation system, combined with its globally pioneering four-dimensional mapping system, enables precise mapping and ablation of cardiac electrophysiological signals, offering a novel solution for the treatment of persistent atrial fibrillation. The system’s entry into the innovation pathway marks significant progress in China in the field of pulsed electric field ablation, with the potential to promote the global application and adoption of this technology, providing more treatment options for patients with atrial fibrillation.

｜3D Electrophysiology Navigation RF Pulse Ablation Enters Innovation Pathway

Medtronic's Electrophysiology 3D Navigation Radiofrequency Pulse Ablation System Enters Innovation Pathway.This system will provide more precise solutions for atrial fibrillation treatment, further solidifying Medtronic's leading position in the electrophysiology field.

As a global leader in cardiovascular device enterprises, Medtronic has always been committed to technological innovation and product development in the field of electrophysiology. The entry of its 3D navigation radiofrequency pulse ablation system into the innovation channel marks a significant advancement in Medtronic's layout in the pulsed electric field ablation technology sector.

This system combines 3D navigation technology with radiofrequency pulse ablation technology, enabling precise mapping and ablation of cardiac electrophysiological signals. It provides a more accurate and effective solution for atrial fibrillation treatment, further solidifying Medtronic's leading position in the global electrophysiology field.

# Clinical Progress (3 cases)

｜World's First Implantation of Left Ventricular Assist Device Based on Wave Membrane Technology

CorWave's Left Ventricular Assist Device Based on Wave Membrane Technology Completes World's First Implantation, with Its Unique Wave Membrane Pump Design Capable of Simulating the Pulsatile Function of a Natural Heart, providing more physiological blood flow support for patients with advanced heart failure, reducing the risk of complications, and improving quality of life.

Left Ventricular Assist Device (LVAD) has been widely used in recent years as an important treatment for heart failure.

The successful global first implantation of CorWave's wave membrane technology-based LVAD marks a significant breakthrough in the clinical application of this technology. Its wave membrane pump design can better simulate the pulsatile function of the natural heart, providing more physiological blood flow support, reducing hemodynamic fluctuations, thereby lowering the risk of complications and improving patients' quality of life, offering new hope for patients with end-stage heart failure.

｜The First 24-Month Patency and Functional Integrity of the Bypass Graft Achieved

Xeltis' Xabg Demonstrates Good Safety and Patency 24 Months Post-Implantation in Patients, Setting a World-First Record. This breakthrough offers new possibilities for the application of artificial blood vessels in coronary artery bypass surgery, with the potential to improve long-term outcomes for patients with coronary heart disease.

Coronary artery bypass grafting (CABG) is one of the key treatments for coronary heart disease, and the patency and safety of artificial blood vessels are crucial to the success of the surgery and the long-term prognosis of patients. Xeltis' Xabg artificial blood vessel maintained excellent patency and functional integrity 24 months after implantation in patients. This outcome not only provides a new option for the application of artificial blood vessels in coronary artery bypass surgery but also brings new hope for the long-term treatment and recovery of patients with coronary heart disease, with the potential to further improve the long-term prognosis of these patients.

｜World's First Infant Heart Transplant from a Circulatory Death Donor

The New England Journal of Medicine (NEJM) published a significant breakthrough by the Duke University Health Center team regarding pediatric heart transplantation:The surgical team at the center successfully completed the ex vivo resuscitation of a DCD (donation after circulatory death) donor heart on the operating table and performed the world's first DCD infant heart transplant.

This groundbreaking surgery opens up a new pathway for the use of donor hearts after circulatory death in pediatric patients, circumventing the current ethical and technical barriers faced in DCD heart transplantation within pediatric applications. It offers new possibilities for expanding donor resources and saving critically ill children.

Heart transplantation is an important treatment for end-stage heart failure, but due to a shortage of donors, many patients are unable to receive transplants in time. This groundbreaking surgery by the Duke University Health Center team provides new approaches and methods for the use of DCD hearts in pediatric patients, with the potential to further expand donor resources and save the lives of more critically ill children, holding significant clinical importance and social value.

# Earnings Release (3 Companies)

｜Johnson & Johnson Releases Q2 Results, Cardiovascular Business Surges 23.5%

Johnson & Johnson (NYSE: JNJ) announced its Q2 2025 earnings report, with Q2 revenue reaching $23.7 billion (approximately RMB 170 billion), representing a year-over-year increase of 5.8%.Among them, the sales revenue of the medical device business reached 8.5 billion U.S. dollars, increasing by 7.3% year-on-year.Cardiovascular business sales reached $2.313 billion, a year-on-year increase of 23.5%., becoming the core driving force for the growth of the medical device business. The electrophysiology business achieved sales of $1.47 billion, a year-on-year increase of 11%, reversing the previous decline. Johnson & Johnson's innovative products in the electrophysiology field, such as the Varipulse pulsed field ablation system, have completed over 10,000 surgeries, driving the growth of this business. Additionally, the cardiac intervention pump business also showed strong performance, with sales of minimally invasive heart pump products increasing by 18.2% year-on-year. Johnson & Johnson plans to continue advancing the commercialization process of Varipulse PFA technology and expand surgeries to more countries and regions, further solidifying its leading position in the cardiovascular field.

Johnson & Johnson's continuous innovation and market expansion in the cardiovascular field have led to significant performance growth in Q2 2025. The surge in the cardiovascular business has not only brought considerable economic benefits to the company but also provided more treatment options and hope for cardiovascular patients worldwide.

｜MicroPort EP Releases Semi-Annual Report, Net Profit Increases by 76.34%

Shanghai MicroPort EP MedTech Co., Ltd. (referred to as “MicroPort EP”) released its earnings forecast for the first half of 2025, expecting revenue between 215 million yuan and 230 million yuan, representing a year-over-year increase of 8.39% to 15.95%; net profit is expected to be between 30 million yuan and 35 million yuan, reflecting a year-over-year growth of 76.34% to 105.73%.

As a leading cardiac electrophysiology medical device company in China, MicroEP has achieved remarkable success in technological innovation and market expansion in recent years. The significant growth in revenue and net profit in the first half of 2025 reflects its continuous innovation capabilities and market competitiveness in the cardiac electrophysiology field. The company keeps launching new products and technologies to meet market demands, driving rapid business growth. Meanwhile, its expansion in both domestic and international markets has made positive progress, further increasing its market share and brand influence, laying a solid foundation for long-term development.

｜Edwards Releases Q2, TAVR Business Sales Reach $7.9 Billion

Edwards Lifesciences (NYSE: EW) released its second-quarter financial report for the period ending June 30, 2025.Total sales in the second quarter reached $1.53 billion (approximately RMB 11 billion), a year-on-year increase of 11.9%, with an adjusted growth of 10.6%.Among them,Transcatheter Aortic Valve Replacement (TAVR) sales reached $1.1 billion (approximately RMB 7.9 billion), representing an 8.9% year-over-year increase.；Transcatheter Mitral and Tricuspid Therapies (TMTT) sales reached $134.5 million, adjusted to $133 million, a year-over-year increase of 57%, primarily driven by the PASCAL and EVOQUE technologies; surgical business sales were $267 million, a year-over-year increase of 7.7%. Despite a 7.7% decrease in net profit compared to the same period last year, adjusted earnings per share (EPS) was $0.67, surpassing the Wall Street consensus estimate of $0.62. The company's strong financial performance was positively received by the market, with its stock price rising over 3% after the earnings report.

Edwards Lifesciences' continuous innovation and market expansion in the field of structural heart disease treatment have led to outstanding financial performance in Q2 2025. The robust growth of the TAVR business and the rapid growth of the TMTT business have further solidified the company's leading position in the global structural heart disease treatment market, providing strong support for the company's long-term development and enhancement of market competitiveness.

GCC2025

Award Review:

21 Items! 2025 Global Cardiovascular Innovation Series Awards

Conference Review:

Review: The First Global Cardiovascular Conference | GCC2025

Cardiovascular Device Full Disease Solution

Structural Heart Disease → ▌Medtronic

Vascular Disease → ▌Huamai Taik Science

Heart Failure → ▌Core Medical

Arrhythmia → ▌Acutus Medical

Vascular Puncture and Closure → ▌Kegang Medical

R&D and Clinical Trial Support → ▌HopeMed