Professor Yang Yaoguo's Team Completes National First-in-Human Application of DEEPQUAKE Peripheral Intravascular Lithotripsy System

Nov 27, 2025 08:00 CST Updated 08:00

Trulive

Structural Heart Disease Device Developer

In the field of泛血管intervention, the treatment of calcified lesions is one of the key and difficult points in clinical practice. Produced by Trulive and promoted by Grand Pharmaceutical Group Limited.DEEPQUAKE Peripheral Vascular Intravascular Shockwave SystemOfficially launched (China Medical Device Registration No. 20243012335). This system is suitable for the pretreatment of calcified lesions and balloon dilatation in the iliac artery, femoral artery, popliteal artery, renal artery, and infrapopliteal artery, offering new treatment options for clinical practice.

This issue is shared with everyoneDEEPQUAKE Peripheral Shock Wave System: First Application in China — A Case of Long-Segment Superficial Femoral Artery Lesion，By Beijing Anzhen Hospital, Capital Medical UniversityProfessor Yang YaoguoCompleted by the team, welcome everyone to read, study, exchange, and discuss.

Features of DEEPQUAKE Peripheral Vascular Intravascular Shockwave System

Advantage 1LargerPulse Energy

Energy adjustable in five levels, with the highest energy reaching 3.2kV (fixed energy of 3.0kV for similar products).

Gear	Energy
Gear 1	2.8kV
Level 2	2.9kV
3-speed	3.0kV
4-speed	3.1kV
5 gears	3.2kV

Advantage 2MoreNumber of electrodes

The balloon is equipped with one pair of electrodes every 8mm, and the three lengths of 40/60/80mm have 4/6/8 pairs of electrodes respectively, ensuring uniform energy release. Treatment stitching does not require "Overlapping."

40mm

4 pairs of electrodes

60mm

6 pairs of electrodes

80mm

8 pairs of electrodes

Advantage 3LongerBalloon Length

Offering an 80mm length balloon, more suitable for long lesions,Reducing operation time and IVL treatment frequency, cost-effective

Case Brief

Patient Basic Information

Patient:Female, 65 years old.

Chief Complaint:Coldness and soreness in both feet for over a month.

History of Present Illness:One month ago, the patient developed a sensation of coldness and soreness in both feet without any obvious cause. There was no nocturnal rest pain, ulcers, or pigmentation, no significant palpitations, shortness of breath, or breathing difficulties, no syncope, and no decrease in muscle strength of the limbs. The patient came to our outpatient department for further treatment. Our ultrasound suggested: multiple stenoses in the right superficial femoral artery lumen, with the narrowest being severe; multiple stenoses in the left superficial femoral artery lumen, with the narrowest being moderate to severe; near occlusion due to severe stenosis in the bilateral posterior tibial and anterior tibial arteries. The outpatient department admitted the patient with a diagnosis of "superficial femoral artery stenosis." Since the onset of the disease, the patient’s mental state, diet, and sleep have been acceptable, with normal bowel movements and no significant weight changes.

Past Medical History:Past medical history: No history of hypertension. Diabetes mellitus for 15 years, treated with oral metformin and subcutaneous insulin injections. No history of hyperlipidemia. No history of cerebrovascular disease. No history of coronary heart disease. No history of trauma. No other significant medical history.

Specialty Situation:No obvious swelling was observed in the patient's lower limbs, with no pigmentation or ulcers. The pulsation of the bilateral femoral arteries was detectable, while the dorsalis pedis arteries and posterior tibial arteries on both sides were not palpable.

Auxiliary Examination:Lower Limb Ultrasound - Multiple stenoses in the lumen of the right superficial femoral artery, with the narrowest being severe; multiple stenoses in the lumen of the left superficial femoral artery, with the narrowest being moderate to severe; severe stenosis nearing occlusion in bilateral posterior tibial and anterior tibial arteries.

Preoperative CTA:

Diagnosis and Surgical Strategy

Preliminary Diagnosis:1. Superficial femoral artery stenosis; 2. Lower extremity atherosclerotic occlusive disease; 3. Occlusive arteriosclerosis; 4. Varicose veins of the lower extremities; 5. Type II diabetes; 6. Hyperlipidemia.

Name of the surgical procedure:Percutaneous Femoral Artery Balloon Angioplasty, Percutaneous Popliteal Artery Balloon Angioplasty, Percutaneous Lower Limb Artery Balloon Angioplasty, Superficial Femoral Artery Shockwave Balloon Angioplasty, Anterior Tibial Artery Balloon Angioplasty, Lower Limb Arteriography, Internal Iliac Arteriography, Arterial Puncture Site Closure.

Lesion Location:Superficial Femoral Artery, Popliteal Artery, Anterior Tibial Artery.

Surgical Approach:Left common femoral artery.

Whether to cross the mountain:Yes.

Baseline Angiography

After satisfactory anesthesia, the left common femoral artery was successfully punctured using the Seldinger technique under ultrasound guidance. A 6F femoral arterial sheath was inserted. Angiography showed that the puncture site was located in the left common femoral artery, with unobstructed blood flow at the origins of the left deep and superficial femoral arteries. Blood flow was also unobstructed in the bilateral external iliac, internal iliac, and common iliac arteries. Using a hydrophilic guidewire in conjunction with a multipurpose catheter and a deflectable catheter, the "crossover" technique was employed to access the right superficial femoral artery. An Ampalz guidewire was then exchanged, and an 8F-45cm long sheath was advanced for step-by-step angiography: Severe stenosis was observed at the origin and mid-to-distal segment ("adductor canal") of the right superficial femoral artery, with severe circumferential calcification; moderate to severe stenosis was noted in the proximal segment of the right popliteal artery; severe stenosis at the origin of the right anterior tibial artery with distal occlusion; the right tibioperoneal trunk remained patent, while the peroneal artery and posterior tibial artery were occluded, with collateral circulation formed around the area.

Lesion Opening Process

Multipurpose catheter and deflectable catheter, in cooperation with a super slippery guidewire and V-18 guidewire, passed through the superficial femoral and popliteal artery stenosis segments. NAV6 filter wire was exchanged and successfully advanced into the anterior tibial artery. The NAV6 filter was deployed at the P2 segment of the popliteal artery.

Shockwave Balloon Lesion Treatment Process

Insert a PCE balloon (3*150mm) to pre-dilate the stenotic segments of the superficial femoral artery and popliteal artery.

Considering the severe calcification of the stenotic segments in the patient's superficial femoral artery and popliteal artery, a DEEPQUAKE shockwave balloon 6mm*80mm was chosen to dilate the stenotic segments of the superficial femoral artery and popliteal artery respectively (balloon pressure up to 4atm, 3 levels of shockwave intensity for 3 cycles). Under fluoroscopy, the shockwave balloon gradually expanded fully.

Exciting Moments During the Surgery

Disease Treatment Process

A drug-coated balloon (6mm*300mm) was delivered to dilate the proximal segments of the superficial femoral artery and popliteal artery to working pressure. After maintaining for 3 minutes, angiography showed: the superficial femoral artery and arterial blood flow were unobstructed, with no embolic shadow observed distally.

Retrieve the protection umbrella, retain the guidewire of the protection umbrella, introduce the PCE balloon (2.5*150mm) to pre-dilate the anterior tibial artery, then introduce the drug-coated balloon (2.5*200mm) to dilate the anterior tibial artery.

Final Angiography

The blood flow in the superficial femoral artery, popliteal artery, proximal and middle segments of the anterior tibial artery, and the tibioperoneal trunk is unobstructed, with a significant improvement in blood flow velocity compared to before. No embolic shadows are seen in the distal segments, and no dissection or contrast agent extravasation is observed.

Operator Evaluation

The management of calcified lesions has always been a clinical challenge, and traditional treatment methods cannot adequately address calcified lesions.
Shockwave technology is simple to operate, highly effective, and safe to use. No dislodged particles were found in this case of the protection umbrella, making it a powerful tool for addressing calcified lesions.
For diabetic patients, the vascular conditions are relatively poor and the probability of long-term re-occlusion is higher. The concept of "intervention without implantation" using shockwave balloons + drug-coated balloons can leave room for further treatment in the future.

Introduction of Experts

Professor Chen Zhong

Chief Physician, Second-Level Professor, Doctoral Supervisor, Director of the Vascular Surgery Center at Beijing Anzhen Hospital, recipient of the special allowance from the State Council.

Currently serves as the Standing Director of the Chinese Medical Doctor Association and President of the Vascular Surgery Physicians Branch, Vice President of the China-Japan Medical Science and Technology Exchange Association and President of the Vascular Surgery Branch, Head of the Vascular Surgery Group of the Surgery Branch of the Chinese Medical Association, Founding Chairman of the Vascular Surgery Branch of the Cross-Straits Medical and Health Exchange Association, etc.; serves as the Deputy Editor-in-Chief of the "Chinese Journal of Vascular Surgery," Associate Editor of the "China Journal of Vascular Surgery," Editorial Board Member of the "Chinese Journal of Surgery," "Chinese Journal of General Surgery," "Chinese Journal of Practical Surgery," and International Editorial Board Member of the "Annual of Vascular Surgery." Has been engaged in the vascular surgery profession for 40 years and is a renowned authoritative expert currently active in the field of vascular surgery with significant academic influence.

As the leader or key member, participated in multiple research projects including the National "863" Project, National Natural Science Foundation, Beijing Natural Science Foundation, and Beijing Municipal Science and Technology Commission’s R&D projects. As the first author or corresponding author, published over 240 professional academic papers in top-tier national journals, 33 SCI articles, and received five provincial and municipal scientific research achievement awards. Also served as the chief editor or translator for several books.

Repeatedly awarded the "Outstanding Contribution Award for Stroke Screening and Prevention" issued by the National Health Commission, "2016 Outstanding Expert in Stroke Prevention and Treatment Project of the National Health and Family Planning Commission," received the honorary titles of "Sincere Doctor," "National Renowned Doctor — Excellence in Achievement Award," and "People's Good Doctor" in 2018, awarded the "Golden Scalpel Award" as part of the Honored Doctors in 2020, received the "Elite Model Award" from the National Health Commission’s Stroke Prevention and Treatment Project in 2021, and honored with the title of "Outstanding Communist Party Member" by the Beijing Municipal Health Commission.

Professor Yang Yaoguo

Deputy Director of the Department of Vascular Surgery, Beijing Anzhen Hospital, Capital Medical University; Chief Physician; Professor; Doctoral and Postdoctoral Supervisor; Member of the Communist Party of China; Member of the Second Surgical Branch Committee.

Deputy Director and Secretary of the Youth Committee of the Vascular Surgery Physicians Branch of the Chinese Medical Doctor Association; Deputy Director and Secretary of the Youth Committee of the Vascular Surgery Branch of the Beijing Medical Association; Member of the Aortic Group of the Vascular Surgery Branch of the Beijing Medical Association; Deputy Director of the Youth Committee of the Vascular Surgery Branch of the Beijing Medical Doctor Association; Chairman of the Vascular Surgery Branch of the Middle-aged and Elderly Disease Management Committee of the China Anti-Aging Promotion Association; Member and Secretary of the Vascular Surgery Committee of the Disease Diagnosis Group of the National Health Commission; Standing Committee Member of the Vascular Surgery Branch of the China International Exchange Promotion Association for Medical and Healthcare; Deputy Director of the Youth Committee of the Chinese Division of the International Vascular Alliance; Judge of the National Natural Science Foundation; Editorial Board Member of the Chinese Journal of Vascular Surgery; Editorial Board Member of the Chinese Journal of Vascular Surgery (Electronic Edition); Editorial Board Member of the Chinese Journal of General Surgery; Reviewer for Annals of Vascular Surgery;

Awarded as an Outstanding Physician by the Beijing Medical Association in 2011; received the Young Scholar Award from the Chinese Surgical Society in 2013; won the Excellence Award at the Young Forum of the Peking University Vascular Forum in 2014; recognized as an Outstanding Teacher by Beijing Anzhen Hospital, Capital Medical University in 2014; awarded the Third Prize of Beijing Medical Science and Technology Award in 2015; named an Outstanding Physician by the Beijing Medical Association in 2016; honored with the Excellent Paper Award (Medical Category) during China Surgery Week in 2019; received the Rising Star Award among National Renowned Physicians in 2019; recognized as an Outstanding Mentor by the Sixth Clinical Medical College of Capital Medical University in 2022; awarded as an Outstanding Employee by Beijing Anzhen Hospital, Capital Medical University in 2023; has led four projects funded by the National Natural Science Foundation of China, obtained eight national patents, and published over 30 papers in domestic core journals and international SCI journals.

Grand Pharmaceutical

The field of precision interventional diagnosis and treatment for cardiovascular and cerebrovascular diseases is one of the core strategic areas of Grand Pharmaceutical Group Limited. Upholding the concept of "precision treatment," the company has made comprehensive arrangements in multiple directions, including pathway management, structural heart disease and heart failure, and neurointervention, building a high-end medical device product cluster. Currently, this sector has arranged more than 30 products. The company is committed to developing this sector into a leading "precision interventional diagnosis and treatment platform for cardiovascular and cerebrovascular diseases" in China and even globally.

Trulive

Jiangsu Trulive Medtech Co., Ltd. focuses on the field of cardiovascular diseases, which have extremely high mortality and disability rates and where the domestic market remains a blank slate. Its business comprehensively covers multiple interventional treatment areas such as heart valves, peripherals, and coronary arteries. It is a platform enterprise that takes the lead in providing a one-stop innovative solution for blood flow management on a global scale. Relying on its strong research and development capabilities and an experienced, complete operational team, Trulive Medtech has developed high-quality, proprietary medical devices and comprehensive solutions with independent intellectual property rights, filling the gap in China's high-end cardiovascular interventional medical device market. This provides Chinese doctors and patients with more advanced and diverse treatment options. Meanwhile, while rooted in China, Trulive Medtech is expanding globally. With continuous technological innovation and development upgrades, the company is accelerating the expansion of its global commercial network, offering "Chinese solutions" and contributing "Chinese wisdom" to various niche markets in the cardiovascular intervention field that have long been monopolized by imported products.

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