Puchuang Medical Secures First Overseas Approval for China-Developed Intravascular Lithotripsy System

# SONICO-CX® Introduction

Spectrumedics' independently developed and innovativeCoronary Intravascular Shockwave Treatment SystemBySONICO-CX® Single-Use Coronary Intravascular Shockwave Catheter(National Medical Device Registration Approval No. 20243010464) andIntravascular Shockwave Treatment Device(China Medical Device Registration No. 20243010505) Composition.

The device transmits shock waves through a waveguide tubeProvide pulsed driving power360° CircumferentialIntermittent Release of Shock Waves, the sound wave energy directly hits the calcified plaques in the intima and media and breaks them apart,Restore vascular compliance while avoiding damage to the vascular intima.。

SONICO-CX® Single-Use Coronary Intravascular Shockwave CatheterFeatures the highest number of pulses (120) in its class.，Smaller folding outer diameter and more comprehensive specifications and models, which can more accurately match coronary vessels, facilitating better balloon adherence to the vessel wall for improved lithotripsy results.

▲SONICO-CX® Intravascular Lithotripsy System

On June 29, 2024, Professor Ge Lei and Professor Lu Hao from the team of Academician Ge Junbo of Zhongshan Hospital, Fudan UniversitySuccessfully Completed the First Two Applications of the Sonico-CX® Intravascular Shockwave Treatment System After Its Market LaunchThe surgery was successfully completed, demonstrating the excellent performance of the domestically produced coronary artery intravascular shock wave treatment system in addressing complex and severely calcified lesions.

# Coronary IVL China Production Four Certificates

Saihe Medical (First Certificate)

In October 2023, the coronary intravascular shock wave treatment system independently developed by Spectrumedics Medical Technology (Shanghai) Co., Ltd. was officially approved for marketing by the National Medical Products Administration (NMPA), becomingChina's First Approved Domestic Coronary Shock Wave Treatment System。

The system consists of the LiqMagic® C14 single-use coronary intravascular shockwave catheter and the ISL100 Pro intravascular shockwave treatment device. By providing pulsed driving electrical energy to the shockwave catheter, it can deliver divergent, low-intensity shockwave energy outward in a 360° full circumferential 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.

LiqMagic® C14 Shock Wave CatheterThe number of pulses is 100, with a pressure resistance performance / expansion pressure (RBP) reaching 14atm. The specifications and models range from 2.5-4.0mm, with a total of 7 specifications.。

Lepu Medical (Second Certificate)

In January 2024, the coronary shock wave catheter system independently developed by Spectrumedics received approval from the National Medical Products Administration (NMPA) for marketing in China, becomingThe Second Domestically Produced Coronary Shockwave Balloon Catheter System to Hit the Market。

The product primarily delivers unfocused, circumferential, and pulsatile mechanical energy to the lesion during low-pressure balloon dilation, efficiently and safely disrupting both superficial and deep calcifications. It creates multiple, microscopic fractures within the calcified lesion, loosening the calcified plaque without compromising the integrity of the vascular intima, achieving the effect of calcium plaque modification, increasing the lumen area, and improving vascular compliance.

Vesscrack Shockwave Balloon CatheterThe number of pulses is 80, with a pressure resistance performance / expansion pressure (RBP) reaching 12atm. The specifications and models range from 2.5-4.0mm, with a total of 7 specifications.。

Zhonghui Medical (Fourth Certificate)

Spectrumedics Medical Technology (Shanghai) Co., Ltd.HuimedSpectrumedics' self-developed coronary intravascular shock wave treatment system was approved for marketing by the National Medical Products Administration (NMPA) in May 2024.This isThe 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.。

C-Wave® activates the hydroelectric effect with shockwave energy, shattering calcification down to the media layer to achieve lumen gain. It also features iterative improvements in balanced angular discharge for the short-axis plane and continuous discharge for the long-axis plane. Six electrodes are continuously distributed along the long axis in an "S" pattern, offering enhanced开通能力 for continuous, nodular, and eccentric calcified lesions. The counter-rotating dual-electrode pairs are simultaneously activated, effectively energizing four discharge points per activation to generate four shockwaves.The catheter can be triggered 80 times, releasing up to 320 shockwave discharge points in total.。

Blue Sail Medical (Fifth Certificate)

In August 2024, Soni Cracker™-CL, a disposable intravascular coronary shockwave catheter independently developed by Lanfan Boyuan, received approval for market release from the China National Medical Products Administration (NMPA).While retaining the treatment characteristics and effects of IVL technology,The first to add a 15mm long lesion treatment specification, which is currently the only catheter length specification on the market.。

At the same time, SoniCracker™-CL Balloon CatheterThe minimum diameter is 2.0mm, filling the current market gap for the 2.0mm size., this time SoniCracker™-CLA total of 18 specifications and models have been approved, making it the most comprehensive range of shock wave catheters currently available in China., providing more options for clinical use.