Puchuang Medical's First-in-Class Forward-Direction Intravascular Lithotripsy Catheter Successfully Completes First-in-Human Clinical Procedure

Coronary Artery Calcification (CAC)It is a common challenge in the interventional treatment of coronary heart disease, especially in severely calcified lesions, known as the "tough bone" of PCI treatment. Such lesions often lead to issues like difficulty in passing instruments, incomplete balloon expansion, and poor stent placement, significantly increasing surgical risks.

Despite the availability of existing technologies for calcification management, such as high-pressure balloons, rotational atherectomy (RA), excimer laser coronary atherectomy (ELCA), and balloon-based intravascular lithotripsy (IVL), each has its limitations. Notably, balloon-based IVL requires crossing the lesion before taking effect, often presenting challenges in cases of extreme stenosis or chronic total occlusion (CTO) lesions.

In response to this global challenge, SpectrumedicsAcademician Ge Junbo's Team from Zhongshan Hospital Affiliated to Fudan UniversityJointly developed the "Forward Shockwave Catheter," achieving the world's/China's first balloon-free forward shockwave technology, with core advantages including:

This surgery was performed byAcademician Ge Junbo's TeamOperation. The patient is a 65-year-old male with severe diffuse calcification and CTO lesions, making it difficult for conventional pre-treatment devices to pass through.

During the surgery, the antegrade shockwave catheter successfully reached the lesion and effectively fragmented the calcified plaque. Post-operative OCT indicated calcium fracture, and the stent was successfully implanted with good expansion. Angiography showed TIMI grade 3 flow in the distal region. The overall procedure went smoothly, and the patient remained stable. Details are as follows:

Preoperative CAG indicated: diffuse severe calcification with severe stenosis (over 90% at its worst) in the proximal and middle segments of the left anterior descending artery, and CTO in the middle and distal segments.

 

After the guidewire passed through the lesion, the balloon had difficulty passing through, so forward shockwave was applied for "excavation-style" treatment.

OCT examination after forward shock wave treatment suggests the appearance of calcification fracture lines.

Follow-up OCT after stent treatment showed good stent apposition, and follow-up angiography indicated satisfactory stent expansion, no residual stenosis, and distal TIMI grade 3 flow.

Director of Cardiology, Dr. Lu Hao, Zhongshan HospitalPostoperatively, they commented: "Complex calcified lesions, especially those with severe stenosis where devices are difficult to pass through, have been our greatest challenge over the long term. This time...Spectrumedics and Zhongshan Hospital Jointly Developed Antegrade Shockwave Catheter Successfully Validates Clinical Feasibility and Great Potential, Offering a New Solution for the Most Challenging Calcified Lesions.”

Dean Qian Juying of Zhongshan HospitalIn conclusion, "The successful implementation of this first-ever surgery not only verifies the efficacy and safety of the forward shockwave catheter in managing extremely complex calcified lesions but also marks a crucial step forward in China’s independent research and development as well as clinical translation of coronary interventional devices. This technology truly addresses clinical needs, overcomes the limitations of existing devices, and reflects an innovative concept centered on solving patient problems. We look forward to this product accumulating more evidence in subsequent clinical trials, reaching clinical application at an early date, advancing the treatment strategies for coronary calcification, and providing China's wisdom and solutions to the world."