Zhenyi Medical Announces NMPA Approval of DEEPQUAKE™ Peripheral Intravascular Lithotripsy System

· Larger pulse energy

DEEPQUAKE™ IVL offers five adjustable energy levels. For mild calcification, low-level energy output is selected, while for severe calcification, high-level energy output is chosen. In pre-market clinical trials, approximately 20% of enrolled patients who showed poor response to level 3 energy treatment were successfully treated after upgrading to level 5. Additionally, about 4% of patients who did not respond well to level 4 energy treatment also achieved the desired outcome after escalating to level 5. DEEPQUAKE™ IVL provides more options to enhance the treatment efficiency of severe calcified lesions.

· A larger number of electrodes

DEEPQUAKE™ IVL Balloon with up to 8 electrodes emits shockwaves to calcified lesions from different positions, ensuring uniform energy release, increasing the probability and number of micro-cracks, and enhancing treatment effectiveness; meanwhile, multiple electrodes disperse energy output, reducing localized vascular wall injury. Moreover, DEEPQUAKE™ balloon expansion for long lesions does not require overlapping, alignment of the balloon marker bands is sufficient. DEEPQUAKE™ IVL, with a higher number of electrodes, releases energy uniformly and dispersively to improve its safety and efficacy.

· Longer balloon length

DEEPQUAKE™ IVL offers an 80 mm long balloon to accommodate long lesions, shorten procedure time, and reduce the number of IVL treatments; it saves pulse emissions when treating lesions of the same length, providing convenience for the treatment of long lesions.

Trulive