The C-Wave® Coronary Intravascular Lithotripsy Catheter System(CC)

Shanghai H&H Medical Technology Co., Ltd. (hereinafter referred to as " H&H Medical") has officially received approval from the National Medical Products Administration (NMPA) for the market launch of its self-developed intravascular shockwave therapy system for coronary arteries!

This is a shockwave catheter featuring proprietary intellectual property and a unique S-shaped helical electrode design, offering more uniform energy distribution and more stable discharge performance.

With this innovation, H&H Medical’s C-Wave® has become the first Chinese brand to offer shockwave catheters for both coronary and peripheral vascular applications.

Coronary Vascular Calcification: A “Hard” Challenge in Interventional Cardiology

C-Wave®, an intravascular lithotripsy (IVL) catheter system independently developed by Zhonghui Medical—a subsidiary of Shanghai H&H Medical Technology Co.,Ltd.—is indicated for the treatment of coronary artery calcification and chronic total occlusions that are difficult to cross with stents.
Led by Professors Chen Shaoliang and Zhang Junjie from Nanjing First Hospital, this innovative device received China’s National Medical Products Administration (NMPA) registration approval in 2024 (Approval No.: Guo Xie Zhu Zhun 20243010990).

Coronary calcification has long been one of the most formidable challenges in interventional cardiology. Conventional tools such as cutting balloons, scoring balloons, and rotational atherectomy have provided cardiologists with effective means to achieve lumen gain. However, when confronted with deep medial calcification, eccentric calcification, or circumferential calcification, these approaches often fall short in efficacy or safety. Intravascular lithotripsy (IVL) has emerged as a novel, highly effective, and safe solution for precisely these complex scenarios.

IVL combines electrohydraulic lithotripsy with balloon-based vessel expansion. It innovatively delivers acoustic shockwave energy to transiently generate high-pressure microbubbles at the site of calcification. These microbubbles create localized high-impedance zones that selectively fracture calcified plaque—without damaging the vascular intima or causing dissection or perforation.

Building upon established IVL technology, H&H Medical has further refined its system. While preserving IVL’s core mechanism—using shockwaves to activate electrohydraulic effects and fracture calcifications down to the media layer to achieve optimal lumen gain—the company has introduced key innovations. Specifically, C-Wave® features proprietary intellectual property and an optimized electrode configuration that enables balanced energy delivery across the short-axis plane and continuous discharge along the longitudinal axis. This advancement enhances procedural consistency, efficacy, and safety in real-world clinical use.

With the launch of C-Wave®, H&H Medical becomes the first Chinese company to offer IVL solutions for both coronary and peripheral vascular applications—marking a significant milestone in domestic innovation for the treatment of vascular calcification.

Innovative by Design, Protected Globally

Publicly available information indicates that Shockwave® was the first to apply intravascular lithotripsy (IVL) technology to coronary interventions. Its catheter features a ring-shaped electrode configuration, concentrating energy primarily at the proximal and distal ends of the treatment zone—demonstrating strong clinical efficacy in coronary calcified lesions.

Recognizing the distinct characteristics of Chinese patients—who often present with more severe, circumferentially extensive, and longitudinally continuous calcification—Huihe Medical’s C-Wave® pioneered a novel S-shaped helical electrode layout. This design arranges six electrodes sequentially along the catheter’s longitudinal axis in a continuous “S”-curve pattern. This architecture enables more uniform and comprehensive energy delivery across complex lesion morphologies, significantly enhancing its ability to treat diffuse calcification, nodular calcification, and eccentric calcified plaques.

To date, Huihe Medical has filed 54 patents globally for its C-Wave® system, with 36 already granted, including 25 invention patents—a testament to the platform’s technological originality and robust intellectual property protection. This global patent portfolio not only underscores Huihe Medical’s commitment to innovation but also positions C-Wave® as a uniquely engineered solution tailored to the evolving needs of interventional cardiology worldwide.

Bipolar excitation one-key operation

As the world’s first intravascular lithotripsy (IVL) catheter featuring an S-shaped helical electrode array, C-Wave® introduces a groundbreaking dual-polarity electrode design with both clockwise and counter-clockwise oriented electrode pairs. This configuration enables simultaneous bipolar firing, activating four distinct discharge sites per trigger and generating four focused shockwaves in a single pulse.

Each C-Wave® coronary catheter supports up to 80 activation cycles, delivering a total of up to 320 precisely targeted shockwave emission points—maximizing treatment efficacy across complex, heavily calcified lesions while maintaining procedural simplicity. With its intuitive one-button operation, C-Wave® streamlines workflow for interventional cardiologists, combining advanced engineering with user-friendly control to tackle even the most challenging coronary calcifications.

Comprehensive Sizing, Intuitive Display

To better address the diverse anatomical needs of Chinese patients, the C-Wave® coronary intravascular lithotripsy (IVL) catheter offers an exceptionally granular sizing range—available in 0.25 mm increments, spanning seven precise diameters from 2.5 mm to 4.00 mm. This extensive selection ensures optimal vessel matching and enhanced procedural precision across a wide spectrum of coronary lesions.

Complementing the catheter system, the C-Wave® shockwave generator (console) features a 7-inch high-resolution color display that provides real-time, at-a-glance visualization of critical parameters—including catheter size, activation status, and cumulative number of shocks delivered. This intuitive interface significantly enhances clinical workflow efficiency and supports informed decision-making during complex interventions—fulfilling the growing demand for transparency and control in modern interventional cardiology.

Pursuing Excellence, Aiming for the Stars

C-Wave® was developed and manufactured by the Zhonghui team under Huihe Medical Group—a company renowned for its deep-rooted capabilities in independent innovation. Huihe Medical has pioneered multiple globally first-in-class medical devices across key therapeutic areas, including structural heart disease, coronary intervention, peripheral vascular intervention, oncology embolization, and intelligent interventional platforms. Many of these breakthrough products have already received regulatory approvals, entered commercialization, and filled critical gaps—not only in the Chinese market but also on the global stage.

Notable innovations include:

• K-Clip®: A transcatheter tricuspid annuloplasty repair system;
• Vispearl®: Radiopaque drug-eluting embolic microspheres;
• S-wan™: A dual-deflectable guiding sheath with precision steering control.

Several of these products have successfully launched in North America, the European Union, and other high-regulatory-barrier markets—demonstrating Huihe Medical’s international competitiveness and commitment to clinical excellence.

The company boasts a robust R&D engine:

• Over 120 dedicated R&D professionals;
• 8,000 square meters of integrated R&D and manufacturing facilities;
• A global IP portfolio of more than 230 patents, including 170 invention patents and over 10 PCT international filings.

Huihe Medical has cultivated deep expertise in high-precision metal machining, computational fluid dynamics (CFD) simulation, and advanced polymer processing—core competencies that underpin its ability to deliver complex, high-performance interventional devices.

Looking ahead, Huihe Medical is committed to collaborating with leading clinicians and researchers to advance the implementation of “Healthy China 2030” and to embody the vision of “New Quality Productive Forces”—driving homegrown innovation that benefits patients worldwide.