Cardiovascular Interventional Products: Innovation and Breakthroughs Reshaping the Industry

Introduction: Cardiovascular Intervention in the Era of Precision Medicine

Cardiovascular disease remains one of the most significant global health threats. In China, approximately 330 million people suffer from cardiovascular diseases, including about 11.39 million with coronary artery disease (CAD). Amid accelerating population aging and the widespread adoption of minimally invasive therapeutic concepts, cardiovascular interventional products are evolving at an unprecedented pace. From the “leave nothing behind” strategy of drug-coated balloons to breakthroughs in intravascular lithotripsy (IVL), from the approval of the first domestically developed interventional artificial heart to the clinical deployment of vascular interventional surgical robots, a series of milestones indicate that cardiovascular interventional therapy has entered a brand-new phase. Simultaneously, volume-based procurement (VBP) policies continue to reshape the industry landscape, domestic substitution is accelerating, and the cardiovascular intervention sector is moving from “data prosperity” towards “value creation”.

This article systematically reviews the latest developments in cardiovascular interventional products across three dimensions: recent major product milestones, technological innovation frontiers, and industry ecosystem trends.

I. Recent Major Product Milestones: Frequent Breakthrough Events

1. Interventional Artificial Heart: First Domestic Approval, a Hundred-Billion Market Formally Launched

In December 2025, the interventional artificial heart developed by Shenzhen Core Medical Technology Co., Ltd. received approval from the National Medical Products Administration (NMPA), becoming the first domestically approved product of its kind. The system utilizes miniaturized axial-flow motor technology for short-term left ventricular support. As a domestic first-in-class technology, it fills a critical gap in China’s interventional cardiac assist device sector.

Interventional artificial hearts are primarily used in high-risk percutaneous coronary intervention (PCI) and acute critical conditions such as cardiogenic shock. Globally, Abiomed’s Impella series is the benchmark product in this field, with over 400,000 cumulative applications worldwide and a fiscal year 2025 revenue of 1.751 billion, demonstrating strong growth resilience. Johnson & Johnson’s 16.6 billion acquisition of Abiomed in 2022 further highlighted the significant commercial value of this sector.

Notably, in addition to Core Medical’s approved product, more than ten domestic companies are developing interventional artificial hearts. Many of these have completed clinical trials or are nearing completion, with a high probability of receiving NMPA approval in 2026. The year 2026 is expected to be a “collective approval year” for interventional artificial hearts, reshaping the multi-billion dollar market landscape.

2. Intravascular Ultrasound: Domestic 60 MHz High-Definition Catheter Approved, Adding New Tool for Precision PCI

On March 13, 2026, Boston Scientific announced that its disposable intravascular ultrasound (IVUS) diagnostic catheter, the OptiCross™ HD, had received NMPA approval and would be locally manufactured at its Lingang production base in Shanghai. This marked Boston Scientific’s first domestically produced medical device approved at its own China manufacturing facility.

OptiCross™ HD is the first 60 MHz high-definition IVUS catheter approved in China. It employs advanced composite transducer and broadband technology, delivering high-resolution imaging while maintaining excellent tissue penetration. It clearly visualizes the three-layer structure of the vessel wall and plaque morphology, helping physicians accurately assess lesions and optimize treatment strategies, thereby improving procedural efficiency and therapeutic outcomes.

IVUS is often referred to as the “third eye” of coronary interventional physicians and has become a new “gold standard” for coronary vessel assessment. However, the current application rate of IVUS in PCI procedures in China is only about 18%, significantly lower than over 50% in developed countries and 90% in Japan. With local production, access to high-definition IVUS technology is expected to improve dramatically, driving the broader adoption of precision PCI.

Around the same period, the intravascular ultrasound therapeutic device and single-use coronary intravascular ultrasound guidewire developed by Shanghai MicroPort Rhythm Medical Technology Co., Ltd. also received NMPA approval. This product uses piezoelectric ultrasonic frequency mechanical vibration technology and is the first domestic ultrasonic guidewire system that utilizes mechanical vibration to treat coronary chronic total occlusion (CTO) lesions.

3. Shortened DAPT Duration for Coronary Stents: Sino Medical’s HT Supreme™ Receives EU Approval

On May 20, 2026, Sino Medical Sciences Technology Inc. announced that its HT Supreme™ drug-eluting stent (DES) system had received European Union approval for a DAPT (dual antiplatelet therapy) duration as short as one month following implantation in the overall CAD patient population. This approval was based on the company’s post-market pivotal clinical study, PIONEER IV, whose interim results were published in the European Heart Journal in February 2026.

This approval marks a critical step forward in optimizing post-procedural medication regimens for coronary intervention globally, helping to reduce the bleeding risk and economic burden associated with long-term antiplatelet therapy, while enhancing the product’s competitiveness in Europe and global markets.

4. Other Significant Approvals

The Concave Supra integrated arch triple-branch reconstruction system, jointly developed by Lifetech Scientific and Professor Chang Shu of Fuwai Hospital, entered the NMPA Innovative Medical Device Special Review Process. This globally first-in-class product offers a no-cerebral-ischemia integrated solution for triple-branch arch reconstruction, suitable for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers. Twelve-month follow-up from feasibility studies showed excellent apposition of the stent to the aortic arch and branch arteries, no endoleak, patency of all branch arteries, and no adverse events.

Additionally, Acotec Scientific’s coronary over-the-wire (OTW) balloon dilation catheter (Jingyi) received NMPA registration approval; MicroPort Endovascular’s peripheral vascular microcatheter (Torqueflex/Linglong Tube) was approved for market; and the NMPA sequentially approved multiple innovative products, including transcatheter aortic valve systems, transcatheter mitral valve clip systems, and biodegradable patent foramen ovale (PFO) occluder systems, indicating continued strong innovation in the structural heart intervention sector.

II. Technology Innovation Frontiers: From “Leave Nothing Behind” to Intelligent Revolution

1. Intravascular Lithotripsy (IVL): Breaking the Bottleneck in Calcified Lesion Treatment

Coronary calcified lesions have long been a “tough nut to crack” in interventional therapy. Balloons often fail to fully dilate calcified plaques, and traditional techniques face challenges such as procedural complexity and high complication risks. IVL innovatively applies the principle of lithotripsy from urology to the vascular field, delivering pulsatile sonic energy to selectively fracture deep calcium deposits in the intima and media while minimizing injury to normal tissue.

Grand Pharmaceutical’s DEEPQUAKE-C coronary IVL system recently received NMPA approval, enriching the “toolbox” for calcified lesion pretreatment and helping coronary intervention enter a new phase of “precision calcium modification”.

BlueSail Medical is also highly active in this area. Its self-developed Sonicracker™ coronary IVL system features innovations including a patented double-layer balloon material, multi-segment variable-diameter catheter, and patch-convex ring electrodes, achieving breakthroughs in pressure resistance, trackability, and acoustic pressure distribution. In August 2025, BlueSail Medical initiated the SONICURE clinical study, the world’s first IVL clinical study specifically targeting in-stent restenosis (ISR). This prospective, multicenter, randomized controlled trial aims to fill critical evidence gaps for IVL in treating severe calcification-induced ISR.

2. Vascular Interventional Surgical Robots: Advancing Force Feedback and Intelligence

Surgical robots are among the most anticipated directions in cardiovascular intervention. At the 2026 Zhongguancun Forum Annual Conference, Wego Medical showcased a domestically developed coronary interventional surgical robot, which was the first approved for market in China and features “force feedback” capability. It can collect real-time interaction forces between instruments and the vessel wall, transmitting the signal to the physician without delay, with a minimum force sensing accuracy of 0.01 N (approximately 1 gram equivalent). The system supports remote operation, allowing physicians to operate without lead aprons, fundamentally reducing radiation exposure.

In March of the same year, XCath, a vascular intervention robot company, announced the completion of a $30 million (approximately RMB 210 million) Series C funding round, co-led by Middle Eastern investment institution Crescent Enterprises and the "father of surgical robots". The cumulative funding amount reached $92 million. The company's core product, the Iris vascular intervention robot system, has successfully completed its first human clinical use

At the 93rd CMEF exhibition in April, the MicroPort Group showcased core products across five major sectors, focusing on robotic surgery, coronary intervention, and pan-vascular disease treatment. Meanwhile, Rayner Surgical Intelligence launched a fully automated AI-powered vascular interventional surgical robot, demonstrating the trend towards deep integration of AI and surgical robotics.

3. Drug-Coated Balloons and the “Leave Nothing Behind” Strategy

Drug-coated balloons (DCBs) have become an important direction in coronary intervention by enabling a “no-implant” strategy. The sixth round of national VBP (for DCBs and urological access products) officially took effect on May 31, 2026. The winning bid prices for DCBs ranged from RMB 1,677 to RMB 6,015, covering major players such as B. Braun, Boston Scientific, Acotec, Lepu, and Gore. DCB list prices were previously generally above RMB 20,000. After this VBP round, mainstream product prices have been clarified, significantly reducing the financial burden on patients.

III. Industry Ecosystem and Market Trends: Market Size Exceeds RMB 90 Billion as Domestic Substitution and VBP Reshape the Landscape

1. Sustained Market Expansion

The Chinese cardiovascular interventional device market is experiencing rapid growth. According to statistics from the Guangdong Research Center for Novel Biomaterials and High-End Medical Devices, the compound annual growth rate (CAGR) of China’s cardiovascular interventional device market over the past five years reached 10.2%, and the market size is expected to exceed RMB 90 billion in 2026.

Globally, the market for interventional cardiology equipment and consumables is also expanding robustly. Research and Markets data shows that the global interventional cardiology device market is projected to grow from 15.65 billion in 2025 to 21.76 billion by 2030, at a CAGR of 7.2%.

2. Accelerated Domestic Substitution

Despite rapid market growth, the high-end segment remains dominated by international giants. Medtronic, Boston Scientific, and others hold more than 60% of the high-end cardiovascular interventional device market share. However, the “price revolution” in domestic coronary stents has been remarkable—stent prices dropped from above RMB 10,000 to around RMB 700, achieving a domestic share of 95%. In the IVUS field, although Boston Scientific and Philips remain the top two players, Shenzhen Blinova Medical has captured an 18.02% market share with sales of approximately RMB 16 million, demonstrating the rise of domestic competitors.

In coronary intervention, guidewires and catheters still face the challenge of low domestic substitution rates. However, in high-end areas such as cardiac electrophysiology and transcatheter valves, domestic innovation is accelerating. A total of 76 innovative medical devices were approved in 2025, including multiple cardiac pulsed field ablation (PFA) systems receiving dense approvals.

3. Normalization of VBP and “Anti-Involution”

As experts in the field ha2026 is regarded as a “gear-shifting year” for high-value consumable VBP. The sixth round of national VBP (DCBs, urological access) has been implemented, with rules explicitly designed to counter “involution” (excessive internal competition)—not simply selecting the lowest bid price to calculate price differences, but using 65% of the average winning price as the price difference control benchmark when the lowest bid is too low. Concurrently, multiple other projects are advancing, including the 27-province cardiac pacemaker alliance VBP and the peripheral Vascular Access microcatheter VBP.

While the price reductions brought by VBP exert short-term pressure on corporate profitability, they also force the industry to shift from “channel-driven” to “innovation-driven” growth, encouraging increased R&D investment, higher clinical value, and accelerated elimination of outdated capacity.

4. Continued Academic Platforms Empowering the Industry

As experts in the fieldIn April 2026, the 24th China Interventional Therapeutics (CIT 2026) annual conference was held in Beijing. Founded by Professor Gao Runlin in 2003, CIT has grown from an initial attendance of over 890 to become one of the most influential international academic platforms for interventional cardiology in the Asia-Pacific region. High-level academic exchange platforms like CIT provide essential support for clinical validation, technology dissemination, and industry collaboration in cardiovascular interventional products.

Outlook: The Road Ahead Driven by Innovation

Cardiovascular interventional products stand at the starting point of a new wave of technological transformation. Cutting-edge technologies such as interventional artificial hearts, IVL systems, and surgical robots are rapidly moving from the lab to the clinic, offering patients more treatment options. Meanwhile, the “anti-involution” shift in VBP policies and the acceleration of domestic substitution are reshaping the competitive logic of the industry. The core competitiveness of enterprises is increasingly shifting from channel capabilities and cost advantages to a comprehensive capacity integrating technological differentiation, clinical evidence, and market access.

In the coming years, the cardiovascular intervention market will undergo profound changes, driven by both technological innovation and policy guidance. Companies that achieve sustained breakthroughs in precision diagnostics and therapeutics, intelligent devices, and differentiated innovation will gain advantageous positions in the next round of industry consolidation. As advocated by the Guangdong Research Center for Novel Biomaterials and High-End Medical Devices, the entire industry must confront its development pain points, target efforts precisely, achieve sharp breakthroughs, and strive for a fundamental transformation from “data prosperity” to “value creation”.

Under the guidance of the “Healthy China” strategy, cardiovascular interventional products will become more accessible, safer, and more intelligent, providing stronger protection for the life and health of hundreds of millions of cardiovascular disease patients.

Disclaimer: This article is for medical popularization, purposes only and does not constitute professional medical advice. Please always follow the diagnosis and treatment plans provided by your treating physician.