
Structural Heart Disease Device Developer
Recently, Jiangsu Trulive Medtech Co., Ltd. independently developed the peripheral intravascular shock wave system — DEEPQUAKE™ (China Medical Device Registration Certificate 20243012326;(Registration Certificate No.: 20243012335) has been reviewed and approved by the National Medical Products Administration (NMPA),Officially Approved for Marketing!
Lower extremity arterial calcific lesions are a pain point in the clinical treatment of PAD. These lesions often involve the intima and media of arteries, commonly seen in the femoral-popliteal artery and the three branches of the calf arteries with atherosclerotic changes, and are often the most difficult areas to dilate during balloon expansion. Intravascular lithotripsy (IVL) is a new technology whose working principle differs from traditional methods for treating calcified lesions. It uses low-pressure balloon dilation to deliver non-focused pulsed acoustic pressure waves into the lesion, breaking up calcified plaques in the vessel wall.
DEEPQUAKE™, as one of the first domestically produced peripheral vascular intravascular shockwave systems to be launched in China,The application of IVL technology on intimal and medial arterial calcification has demonstrated good efficacy and safety in clinical studies. The product offers a high pulse energy, multiple electrode arrangements, and a variety of balloon lengths, providing more treatment options. It can be used for the pretreatment and balloon dilation of calcified lesions (vascular stenosis ≥50%) in the iliac, femoral, iliofemoral, popliteal, renal, and infrapopliteal arteries of adult patients.
· Larger pulse energy
DEEPQUAKE™ IVL offers five adjustable energy levels. For mild calcification, low energy output is selected, while for severe calcification, high 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. About 4% of patients who did not respond well to level 4 energy treatment also achieved therapeutic goals after upgrading to level 5. DEEPQUAKE™ IVL provides more options to improve the treatment efficiency of severe calcified lesions.
· A larger number of electrodes
DEEPQUAKE™ IVL Balloon with up to 8 electrodes emits shockwaves from different positions toward calcified lesions, ensuring uniform energy release, increasing the probability and number of micro-cracks, and enhancing treatment effectiveness; simultaneously, 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 features a higher number of electrodes for even and dispersed energy delivery, improving 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, bringing convenience to the treatment of long lesions.
Trulive's DEEPQUAKE™ Peripheral Intravascular Shockwave System is a significant achievement in the localization of intravascular shockwave technology in China.The approval and market launch of this product will further advance the localization process of products in the field of vascular calcification interventional treatment, expanding and fulfilling the treatment options for a large number of patients with vascular calcification. In the future, Trulive will continue to innovate and develop, constantly providing more safe and effective innovative solutions for patients with cardiovascular diseases, allowing "Chinese wisdom" to serve the world!


