C-Wave® Peripheral Intravascular Lithotripsy (IVL) Catheter System (CP)

The C-Wave® Peripheral Intravascular Lithotripsy (IVL) Catheter System, independently developed by Zhonghui Medical—a subsidiary of H&H Medical—is indicated for the treatment of intravascular calcified lesions in peripheral arteries. It can be used either as a standalone therapy or in combination with stents and other interventional devices.

Product Introduction

Developed independently by Zhonghui Medical—a subsidiary of H&H Medical Group—the C-Wave® Intravascular Lithotripsy (IVL) Catheter and Generator System has received official market approval from China's National Medical Products Administration (NMPA)!

C-Wave® marks a historic milestone as the first domestically developed IVL system to be commercialized in China, and the second IVL platform globally to gain regulatory clearance for clinical use.

This breakthrough innovation empowers interventional cardiologists and vascular specialists with a safe, effective, and precisely engineered solution for treating severely calcified coronary and peripheral lesions—addressing a critical unmet need in endovascular therapy and establishing a new standard of care in vascular intervention.

C-Wave®: The World’s First 360° Full-Sector Intravascular Lithotripsy System

C-Wave®, independently developed by Zhonghui Medical—a subsidiary of H&HMedical Group—is the world’s first intravascular shockwave system engineered for true 360° full-sector calcium modification. Designed to deliver uniform, circumferential energy distribution around the entire vessel lumen, it effectively addresses complex calcified lesions—including eccentric, nodular, and circumferential calcifications—with unprecedented precision and consistency.

The system is built on fully independent intellectual property, underpinned by a robust IP portfolio comprising over 50 patents, including 30 invention patents, as well as 1 PCT international patent and 1 software copyright. This comprehensive protection not only reflects the depth of technological innovation behind C-Wave® but also establishes a strong intellectual property moat, securing its competitive edge in both domestic and global markets.

The C-Wave® pivotal clinical trial was led by Professor Lu Xinwu from the Department of Vascular Surgery at Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, and Professor Fu Weiguo from the Department of Vascular Surgery at Zhongshan Hospital, Fudan University. This study stands as the first and only randomized controlled trial (RCT) conducted in China specifically for an intravascular lithotripsy (IVL) product, setting a rigorous benchmark for clinical evidence in the field of vascular calcification treatment.