Shaihe Medical Successfully Completes First-in-Human Clinical Implantation of China's First Domestic Coronary Intravascular Lithotripsy System

On October 19, 2021, the team led by Professor Li Yan from the Department of Cardiology at Tangdu Hospital of the Air Force Medical University successfully completed the first clinical enrollment of China's first coronary intravascular lithotripsy system, independently developed by SONOSEMI. The procedure was a complete success, fully demonstrating the safety and excellent clinical efficacy of this innovative device.

According to reports, the first patient enrolled in the clinical trial was female. Coronary CTA and coronary angiography revealed an 80% severe stenosis in the proximal segment of the left anterior descending (LAD) artery, accompanied by severe calcification. Given the presence of circumferential medial calcification and localized eccentric calcification, other calcification modification techniques were unlikely to yield favorable outcomes. Consequently, Professor Li Yan’s team utilized a coronary intravascular lithotripsy system to treat the patient.

The Coronary Intravascular Lithotripsy System, independently developed by SONOSEMI, consists of two components: the LiqMagic C14 Shockwave Coronary Balloon Catheter and the ISL100 Pro Intravascular Lithotripsy Generator. Once connected, the control buttons on the operating handle allow physicians to start or stop the intravascular lithotripsy treatment via the generator console, ensuring excellent safety, convenience, and reliability. Radiopaque markers are positioned at both the distal and proximal ends of the balloon to facilitate precise positioning by physicians.

Professor Li Yan stated: “In terms of overall system connectivity, the crossability of the shockwave balloon, and its efficacy in managing medial and eccentric calcifications, this coronary intravascular lithotripsy system demonstrated excellent intraoperative performance. After just one discharge cycle (10 seconds), the calcified stenosis was readily dilated. Following stent implantation, expansion was optimal with no significant residual stenosis. Conquering this 'hard fortress' proved remarkably effortless, and the excellent outcomes have received unanimous recognition from all our colleagues in the cardiology department.”

Mr. Liu Bin, Chairman of SONOSEMI, stated: “We are highly pleased to witness the successful enrollment of the first patient in this clinical study. The advent of the coronary intravascular lithotripsy system provides interventional cardiologists with a highly effective and safe solution for severely calcified plaques that were previously difficult to manage. It significantly reduces procedural risks, enables maximal lumen gain following stent implantation, and ensures optimal stent expansion and apposition. As a homegrown innovative medical device company in China, SONOSEMI will continue to dedicate itself to technological innovation and clinical applications in cardiovascular implantable and interventional devices. We are confident that coronary intravascular lithotripsy technology will serve as a boon to patients with calcified lesions.”

Coronary artery disease (CAD) has long posed a severe threat to patient health. With the increasingly severe trend of population aging, its incidence continues to rise year by year. Coronary artery calcification frequently coexists with various complex CAD lesions, accounting for approximately 20% to 30% of such cases. Advanced age, diabetes mellitus, and renal insufficiency are established risk factors for coronary calcification, which significantly impacts the treatment and prognosis of CAD.

Coronary artery calcified lesions pose a significant challenge in interventional therapy, often described as the "toughest nut to crack" or the "most impregnable fortress." Coronary calcification has become a bottleneck in the management of cardiovascular diseases. A 2014 meta-analysis published in *BMJ* confirmed that coronary calcification is an independent predictor of poor prognosis, with significantly elevated mortality rates among severely calcified patients. Conventional balloons frequently fail to achieve satisfactory expansion, carry a high risk of vessel rupture under high-pressure inflation, demonstrate low device crossability, and result in a high incidence of stent underexpansion following implantation. The high rate of periprocedural complications frequently leads to increased periprocedural myocardial infarction and mortality. Traditional strategies for modifying calcified plaques, including high-pressure balloons, cutting balloons, scoring balloons, and atherectomy (directional/rotational), each possess inherent limitations. These modalities are generally effective only for superficial intimal calcification and remain largely ineffective against medial calcification, eccentric calcified nodules, or severe calcification.

In this context, SONOSEMI adopted a novel system architecture to successfully develop China’s first independently innovated coronary intravascular lithotripsy system. Distinct from traditional techniques for treating calcified lesions, the coronary intravascular lithotripsy system seamlessly integrates acoustic pressure wave lithotripsy technology with a balloon catheter. The lithotripsy balloon incorporates multiple miniaturized, parallel-arranged acoustic pressure wave generators. Delivered to the calcified lesion via the balloon catheter platform, it releases intermittent acoustic pressure waves during low-pressure balloon inflation. By delivering unfocused, pulsed mechanical energy, it efficiently and safely disrupts both superficial and deep calcified plaques within the vascular lumen, thereby significantly improving vascular compliance. 《2021 Chinese Expert Consensus on the Diagnosis and Treatment of Coronary Artery Calcification Lesions》 notes that intravascular lithotripsy is effective not only for superficial calcification but also stands as the only technology in the industry with therapeutic efficacy against deep calcification. It offers a novel option and a powerful “weapon” for the management of coronary calcified lesions, and is poised to become the “terminator” of coronary artery calcification.

SONOSEMI is a high-tech enterprise specializing in the R&D and manufacturing of active vascular implant and interventional medical devices. Its main products include active interventional high-value medical consumables such as shockwave balloon catheters and ultrasonic catheters, covering cardiovascular and cerebrovascular clinical areas including coronary artery disease, peripheral vascular disease, and structural heart disease. Founded in 2020 and headquartered in Shenzhen, the company’s product development team comprises professionals from renowned medical device and ICT enterprises, with extensive design and development experience in medical sensors, vascular interventional devices, and console systems. We will continue to drive technological innovation in medical sensor chip technology, promote the large-scale application of novel sensor-based high-value consumables in the healthcare sector, consistently create value for physicians and patients, and serve as an enabler of smart healthcare.