Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a China-based provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary disposable coronary intravascular impact waveguide tube. This Category III device is now authorized for use in the pre-treatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis degree ≥ 50%) in adult patients prior to stent implantation.
Coronary intravascular lithotripsy (IVL) represents a recent innovation in vascular therapy, delivering unfocused, circumferential, and pulsed mechanical energy to lesions during low-pressure balloon dilation. This approach effectively and safely disrupts superficial and deep calcifications, generating multiple small fragments from the calcified plaque without compromising the integrity of the vascular intima. The technique facilitates calcified plaque modification, expands lumen area, and enhances vascular compliance.- Flcube.com
