Blue Sail Medical Receives NMPA Approval for Disposable Coronary Intravascular Impact Waveguide

China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its disposable coronary intravascular impact waveguide, SoniCracker CL. This product is designed to be used in conjunction with the company’s proprietary coronary intravascular shock wave therapy equipment (model: IVL-HVG-C01) for pre-treatment and balloon dilation of de novo coronary artery calcification lesions with a stenosis degree of ≥ 50% in adult patients prior to stent implantation surgery.

SoniCracker CL, marking one of the first domestically developed coronary intravascular shock wave waveguides in China, introduces a 15mm long lesion treatment specification for the first time while maintaining the treatment features and efficacy associated with IVL (shock wave intravascular lithotripsy technology). This unique catheter length specification addresses a gap in the market. With a minimum diameter of 2.0mm, it fills a void in the current market offerings. The product has been approved across a total of 18 specifications and models, making it the most comprehensive shock wave waveguide available in China currently, thus providing a wider array of options for clinical applications.- Flcube.com

Fineline Info & Tech