Intravascular lithotripsy system generator

Intended purpose

The product is intended for use in medical institutions and is designed to be used in conjunction with Vesscrack Coronary IVL Balloon Dilatation Catheter manufactured by our company for the pretreatment of primary coronary artery calcification lesions (coronary artery stenosis greater than or equal to 50 percent) in adult patients prior to stent implantation or ThorCrack Peripheral IVL Balloon Dilatation Catheter manufactured by our company for the pretreatment of peripheral artery calcification lesions (vascular stenosis greater than or equal to 50 percent) in adult patients, including the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.