Shandong Province's First Successful PCI Using Domestic Intravascular Lithotripsy System for Severe Coronary Calcification

Jan 05, 2024 15:16 CST Updated 15:16

SONOSEMI

Active Vascular Implantable and Interventional Medical Device R&D and Manufacturer

Source of the article:Shandong University Qilu Hospital Dezhou Hospital；Editor: Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently, the Cardiology Department of Qilu Hospital Dezhou Hospital in Shandong ProvinceFirst ApplicationSonosemi Medical Co., Ltd. (referred to as "SONOSEMI")Self-developed Coronary Intravascular Shock Wave Treatment System, successfully conducted a case ofSevere Calcified Stenosis of Coronary ArteryPCI surgery.

The surgery was guided by Dong Hongwei, Executive Director of the Cardiology Department within the hospital, and performed by Deputy Chief Physician Zhang Qiang, leading the coronary artery team. The patient recovered well post-surgery and has now been discharged in good health. The successful completion of the surgery fully demonstrates the systematic strategy and advanced techniques of the hospital’s cardiology department coronary team in treating calcified coronary lesions.

Chinese-Made Shock Wave SystemThe successful application has provided extensive benefits for a wide range of patients."New Weapon" for Handling Coronary Artery Calcification。

# Patient Basic Information

The patient is78-Year-Old Female, was admitted to the cardiology department of the hospital due to recurrent chest pain and later diagnosed withAcute Myocardial Infarction, Severe ConditionBefore coming to the hospital, the elderly patient had been on long-term medication at home, but the chest pain symptoms still recurred. After admission, coronary angiography revealed that the patient’s left anterior descending artery (LAD) and right coronary artery (RCA) both had diffuse severe stenosis and calcification. The narrowest part of the LAD had a stenosis rate of 99%, with only a trickle of blood flow able to pass through the lesion to reach the distal end. This was the exact cause of the patient's recurring angina.

# ImplementationIntravascular Shockwave Therapy

Due to the patient's advanced age and suffering from various diseases such as old myocardial infarction, hypertension, cerebral infarction, bronchitis, gastritis, and femoral head necrosis, the patient is in poor physical condition. Ordinary cardiac stents are difficult to pass through the severely calcified coronary artery lesions, and the patient cannot tolerate surgical bypass surgery. After Zhang Qiang led the coronary team to comprehensively evaluate the patient’s vascular lesions and overall condition, they decided toOCT (Optical Coherence Tomography)-Guided Coronary Artery Intravascular Lithotripsy。

Intraoperative OCT evaluation of the LAD lesion revealed diffuse fibrocalcific plaque with a heavy calcification burden and localized 360° calcification. A 3.0*12mmSONOSEMI Shock Wave BalloonPerform sufficient pre-dilation at the LAD calcified lesion, followed by stent implantation.Follow-up angiography showed satisfactory pre-treatment effect.。

# Expert Interpretation

Zhang Qiang introduced: "The shockwave balloon can play a role in stimulating vibrations, fully targeting subintimal calcification within blood vessels. It can crush circumferential, eccentric, or deep calcified plaques while effectively avoiding the risk of intraoperative complications or complex operations caused by high-pressure balloons or rotational atherectomy treatments. Therefore,For calcified lesions, the shock wave balloon is a very good new tool.。”

# Professional Knowledge Interpretation

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 devices have certain limitations, making coronary artery calcification one of the most challenging conditions faced by interventional cardiologists.Intravascular Shockwave Technology as an Innovative Approach for Treating Vascular Calcified Plaques, it is not only effective for superficial calcification, but also currentlyThe Only Effective TreatmentTreatment Technology for Deep Calcification`, broadening new perspectives for the diagnosis and treatment of complex and severely calcified lesions for a wide range of surgeons.`

This technology provides pulsed driving electrical energy to its shockwave catheter, enabling it to output divergent, low-intensity shockwave energy in a 360° full circumferential and intermittent manner. This exerts a fracturing effect on calcified plaques, improves vascular compliance, and prepares for subsequent treatment.For the intraluminal membrane and normal vascular tissueWill not cause damage。With the gradual widespread clinical application of the coronary artery intravascular shock wave treatment system, it will bring new hope for recovery to more patients with coronary artery calcification.

# SONOSEMIIntravascular Shockwave Therapy System

SONOSEMI Medical Co., Ltd. independently developedThe coronary artery shockwave lithotripsy system consists of two parts: the "LiqMagic C14 Shockwave Coronary Balloon Catheter" and the "ISL100 Pro Intracorporeal Shockwave Therapy Device" (as shown in the figure below). The system employs an innovative vascular calcified plaque fracturing technology.Integration of Traditional Electrohydraulic Lithotripsy and Balloon Angioplasty, creatively applied to the treatment of coronary artery calcified lesions, by preprocessing the vascular lumen, fracturing the existing calcified plaques, significantly improving vascular compliance without damaging normal tissues.

▲Image SourceFrom the company's official website

On October 25, 2023, the National Medical Products Administration announced that the Coronary Intravascular Lithotripsy (IVL) System independently developed by Sonosemi Medical Co., Ltd. has been officially approved for marketing. During the same period, SONOSEMI completed a Series B financing round of over 200 million RMB. The funds raised in this round will be used for the research, development, production, and commercialization of core products.

Overseas Cardiovascular Devices:

Products of Chinese Cardiovascular Companies: