Huihe Medical's Global First S-Shaped Spiral Electrode C-Wave Coronary Lithoplasty System Approved by NMPA

Source: HuiHe Healthcare, Heart Future

Recently, the coronary artery shock wave catheter and system independently developed by Shanghai Huihe Healthcare Technology Co., Ltd. (hereinafter referred to as "HuiHe Healthcare") have been approved for marketing by the National Medical Products Administration (NMPA).

This is the world's first S-shaped spiral electrode C-Wave coronary shockwave catheter, and also the first domestically produced shockwave catheter and system with both coronary and peripheral vascular indications in China.

In August 2023, the C-Wave® Intravascular Shock Wave Catheter and Generator System, independently developed by Huihe Group's subsidiary HuiHe Healthcare, received approval from the National Medical Products Administration (NMPA) for market release. This system became the first domestically produced shock wave system to be launched in China and the second IVL product globally to reach the market.

Thus, HuiHe Healthcare becomesThe FirstA Chinese brand with both coronary and peripheral shockwave catheters.

Coronary artery calcification is a very challenging lesion in percutaneous coronary intervention (PCI), often referred to as "the toughest bone" in PCI. Traditional calcification treatment techniques and instruments have certain limitations, making coronary artery calcification one of the most challenging diseases faced by interventional physicians. As an innovative intravascular calcified plaque treatment technology, intravascular lithotripsy is not only effective for superficial calcification but is also currently the only treatment technology that effectively handles deep calcification, providing a new approach for operators in diagnosing and treating complex and severe calcified lesions.

This technology provides pulsed driving electrical energy to its shockwave catheter, enabling it to output divergent, low-intensity shockwave energy in a 360° full-circle, outward, and intermittent manner. This creates a fracturing effect on calcified plaques, improving vascular compliance and preparing for subsequent treatments, while avoiding damage to the intima and normal vascular tissue within the lumen. With the gradual expansion of clinical applications of the coronary intravascular shockwave treatment system, more patients with coronary artery calcification will gain new hope for restoring their health.

Although traditional cutting balloons, scoring balloons, and rotational atherectomy techniques all provide effective tools for cardiologists to achieve lumen gain when treating vascular calcification.

When facing middle membrane calcification, eccentric calcification, or annular calcification, the latest IVL technology has become an effective and safe solution.

IVL is a combination of hydraulic lithotripsy technology and endovascular dilation technology, using shockwave energy to activate microbubbles at high voltage in an instant, creating high-energy impedance on the calcified surface, thereby cracking stubborn plaques without damaging the intima or causing dissection and rupture.

HuiHe Healthcare has made improvements on the basis of the already marketed IVL and launched the C-Wave® Coronary Shock Wave Catheter with independent intellectual property rights.

C-Wave® is developed and manufactured by the ZhongHui team of HuiHe Healthcare, retaining the inherent characteristics of IVL: activating the hydroelectric effect with shock wave energy to crack calcification down to the middle membrane layer, achieving lumen;

Iterated on the balanced-angle discharge for the short-axis surface and continuous discharge for the long-axis surface, and launched the C-Wave® Coronary Shockwave Catheter with independent intellectual property rights.

Product Features:

S-shaped Spiral Electrode Distribution: Considering the severity of calcified cross-sections and the continuity along blood vessels in Chinese patients, six electrodes are distributed continuously along the long axis in an "S" shape, providing enhanced开通能力 for consecutive calcification, nodular calcification, and eccentric calcification lesions.

Source: Official WeChat Public Account (same below)

Dual Electrode Set:Dual-electrode with clockwise and counterclockwise rotation, both electrodes are activated simultaneously. Each activation effectively activates 4 discharge points, generating 4 shock waves. Each catheter can be activated 80 times, releasing up to 320 shock wave discharge points in total.

Source: Official WeChat Public Account (same below)

Safe and Effective:The registration clinical study of C-Wave® Coronary enrolled 183 patients across 10 hospitals. The success rate of the surgeries and the incidence of adverse cardiovascular events were satisfactory, reaching the same level as international peer clinical trials such as CADIII.

Source: Official WeChat Public Account (same below)

Complete range of models:Specifications are provided in 0.25mm increments, with the catheter (balloon) available in 7 sizes ranging from 2.5mm to 4.00mm.

The shock wave generator (host machine) of C-Wave® is equipped with a 7-inch large display, which can show catheter model, activation status, number of activations and other information, meeting the clinical visualization needs.

Global Patents:HuiHe Healthcare's C-Wave® has applied for 54 patents globally and in China, with 36 already authorized, including 25 invention patents.

Suzhou Zhonghui Healthcare Technology Co., Ltd. was established in December 2020, located in Suzhou Nano Biomedical Park, mainly engaged in the innovative research, development, and production of active medical devices in the cardiovascular field. In August 2021, the company was merged into Shanghai Huihe Healthcare and became its wholly-owned subsidiary.

On August 10, 2023, HuiHe Healthcare's C-Wave® Intravascular Shockwave Catheter and Generator System received approval from the National Medical Products Administration (NMPA) for market launch. C-Wave® has become the first domestically produced shockwave system to be marketed in China and the second IVL product globally to be launched.

Shanghai Huihe Healthcare Technology Co., Ltd. was established in May 2019. It is a technology enterprise specializing in the research and production of cardiovascular implant devices, with independent innovation capabilities. The company owns four industry-leading platforms: delivery system R&D and production, clinical medical technology, precision manufacturing, and global marketing. In the fields of heart valve intervention, vascular intervention, electrophysiological intervention, drug delivery intervention, and intelligent intervention, it has independently developed world-leading related products.

Products cover several fields such as cardiac interventional valves and vascular interventional devices. The first product is the K-Clip, a transcatheter tricuspid annuloplasty system with internationally leading technology. K-Clip has entered the "green channel" for special review of innovative medical devices in China, completed registration clinical research, and submitted a registration application to the National Medical Products Administration (NMPA), with the hope of being approved this year.

HuiHe Healthcare has more than 120 R&D personnel, an 8,000-square-meter R&D and production site, and owns over 230 patents in total, including 170 invention patents and more than 10 PCT patents. The company has established good cooperation with multiple scientific research institutes such as Zhongshan Hospital Affiliated to Fudan University and the Health and Environmental Technology Research Institute of Soochow University. Since its establishment, HuiHe Healthcare has successively completed angel round, A round, A+ round, and B round financing, with investors being well-known institutions such as IDG Capital, Oriza Ventures, Boyuan Capital, Guofang Capital, SDIC Venture, Legend Star, and Shanghai Science and Technology Innovation.