
Vascular Interventional Balloon Product Developer


With the vigorous development of China's peripheral vascular intervention market, ordinary peripheral balloons have entered a stage of full competition. However, for the increasing number of highly resistant stenotic lesions, ordinary balloons can easily cause excessive vascular injury, flow-limiting dissections, hematomas, and other complications. On the other hand, pressure-focused balloons, which utilize cutting/notching elements between the vessel wall and the balloon’s outer diameter during expansion, enhance localized pressure and enable efficient directional dilation. This reduces vascular elastic recoil and represents a new direction in the evolution of vascular intervention balloons.。
DK Medtech Special Release【Professor Chen Zhiyong & Professor Cha Binshan Team: A Case of Scoring Balloon Treatment for No Stenting Zone Lesions】Case Presentation, demonstrating the meticulous operation of each case and the clinical application of advanced equipment and instruments. From the formulation of treatment strategies for different cases, standardized intraoperative procedures and technical applications, complication prevention, to perioperative management, etc., the aim is to promote the standardization of diagnosis and treatment for vascular stenosis and occlusive diseases, strengthen technical exchanges and experience sharing among doctors, with the hope of providing new ideas and methods for future diagnosis and treatment, benefiting more clinical patients.

A Case of Scoring Balloon Treatment for No Stenting Zone Lesions
Department of Vascular Surgery, First Affiliated Hospital of Anhui Medical University

Patient Information
Basic Information:The patient is a 79-year-old female.
Chief Complaint:Intermittent claudication of the right lower limb for half a year, worsened over the past 10 days.
History of Present Illness:The patient developed intermittent claudication six months ago, with a claudication distance of approximately 500 meters. Two months ago, due to acute pain in the left lower limb, the patient underwent left lower limb arteriography + catheter thrombectomy of the left femoral popliteal artery + PTA of the popliteal artery, anterior tibial artery, peroneal artery, and tibioperoneal trunk. In the past 10 days, the claudication distance has decreased and the pain has worsened. The patient came to the hospital for further treatment.
Past Medical History:Hypertension, Cerebral Infarction, Atrial Fibrillation.
Physical Examination:No edema in both lower limbs, gastrocnemius muscles are soft, no ulcers or pigmentation, the pulse of the right femoral artery is palpable, but the pulse of the right dorsalis pedis artery is not palpable, skin temperature is lower than the contralateral side, and the movement of the right foot is mildly restricted.
Admission Diagnosis:Arteriosclerosis Obliterans of the Right Lower Limb.
Preoperative Analysis
Preoperative Analysis:The patient is an elderly male, mainly presenting with intermittent claudication in the lower limbs. He has a long history of the condition. Lower limb arterial CTA indicates diffuse lesions in the right femoral-popliteal artery and infrapopliteal arteries, consistent with his medical history. The diagnosis of lower extremity atherosclerotic occlusive disease is clear, and endovascular treatment is planned.
Surgical Objective:
Main Objectives:Open Occluded Vessels, Relieve Symptoms;
Secondary Objectives:Reduce stent implantation.
Surgical Strategy/Plan:Antegrade puncture and catheterization of the right common femoral artery, angiography to clarify the lesion condition, selection of appropriate guidewire and catheter based on the lesion condition, and endovascular treatment through the lesion segment. Balloon dilation is performed first; if pre-treatment is sufficient, without flow-limiting dissection and residual stenosis, drug-coated balloon dilation therapy is planned.
Surgical Procedure
Occlusion of the distal superficial femoral artery to the popliteal artery, with poor visualization of the infrapopliteal arteries. An 18-guide wire was used in conjunction with a balloon to pass through the femoropopliteal lesion segment. Angiography simultaneously revealed segmental stenosis and occlusion of the anterior tibial artery and peroneal artery, while the posterior tibial artery showed relatively good visualization.
Balloon dilation of the anterior tibial artery with 2.5mm and 3mm balloons, and dilation of the peroneal artery lesion segment with a 2.5mm balloon.
No obvious dissection was observed without angiography after 3mm balloon dilation. Then, a 4mm*80mm scored balloon was used for segmental dilation of the popliteal artery and superficial femoral artery. Repeat angiography showed satisfactory luminal gain in the femoral and popliteal arteries, with no significant dissection or residual stenosis.
A 4mm*150mm Cercor Drug-Coated Balloon by Xianruida was used to dilate the femoral-popliteal artery lesion segment. Post-dilation angiography showed no distal embolism, fast blood flow, satisfactory luminal gain of the femoral-popliteal artery, with no flow-limiting dissection, residual stenosis, or elastic recoil.

Preoperative Angiography

Postoperative Angiography
Follow-up
Discharge Status:
The next day, the patient was able to walk without lower limb pain or weakness. After 2 days of observation, the patient was discharged and instructed to regularly take oral antiplatelet and statin medications (Aspirin 100mg qd + Rivaroxaban 10mg qd + Atorvastatin 10mg qd).
Repeat CTA after 3 months.

Preoperative

3 months post-operation
Case Summary
Case Characteristics:Diffuse lesions in the femoral-popliteal artery and infrapopliteal arteries, combined with mild to moderate calcification. The scoring balloon can perfectly achieve No stenting zone expansion, prevent dissection and elastic recoil, better modify lumen plaque, achieve satisfactory lumen gain, and avoid stent implantation.
Preoperative Assessment Key Points:Nature and length of the lesion.
Surgical Strategy/Technical Key Points:
The 18-guide wire cooperates with the balloon catheter to pass through the lesion segment in the true lumen as much as possible;
First, select a balloon with a diameter smaller than the target lesion to pre-dilate the lesion segment;
Select a 1:1 balloon for the diseased vessel, with a length sufficient to fully cover the lesion;
Low-pressure slow expansion.
Characteristics/Usage Tips of the Device:The scored balloon was slowly inflated with pressure increasing gradually at 2, 4, 6, and 8 atmospheres, each pressure level maintained for 15 seconds to avoid intimal tearing. The dilation lasted more than 3 minutes, followed by a careful assessment of the lesion post-dilation.

Expert Introduction

Professor Chen Zhiyong
Director of Department Administration
Director of the Vascular Surgery Department at the First Affiliated Hospital of Anhui Medical University, PhD, Associate Chief Physician, Master's Supervisor. Vice Chairman of the Vascular Committee of the Anhui Province Physician Association, Member of the Endovascular Committee of the Chinese Physician Association, Member of the Abdominal Aortic Specialized Committee of the International Vascular Union, Standing Committee Member of the Vascular Surgery Committee of the Anhui Medical Association, and Vice Chairman of the VTE Alliance of the Anhui Hospital Association. Areas of expertise: Open and endovascular minimally invasive treatments for aortic and peripheral vascular diseases. Has led and participated in four provincial natural science foundation projects, published over 10 papers, and co-authored four monographs.
Professor Binshan Zha
The Surgeon of This Case
Associate Professor, Deputy Chief Physician, Department of Vascular Surgery, First Affiliated Hospital of Anhui Medical University; Doctor of Surgery, Master's Graduate Supervisor. Visiting Scholar at the Department of Vascular Surgery and Endovascular Surgery, Agaplesion Diakonieklinikum (Rotenburg Wümme), affiliated with the University of Hamburg, Germany, in 2015. Currently serving as the Deputy Chairman of the Youth Committee of the Second Committee of the Anhui Branch of the Asia-Pacific Vascular Academic Alliance, Member of the Vascular Surgery Branch of the Anhui Medical Association, Member of the Vascular Surgery Branch of the Anhui Physician Association, Member of the Aortic Dissection Special Committee of the Endovascular Society of the Chinese Physician Association, Youth Member of the International Vascular Alliance China Branch, Member of the Endovenous Treatment Committee of the Lower Extremity Vein of the Microcirculation Society, and Member of the Anhui Minimally Invasive Medical Association.
Currently, I have been engaged in vascular surgery clinical work for over 10 years, specializing in minimally invasive diagnosis and treatment of common vascular surgical diseases. Professional expertise: Endovascular minimally invasive treatment of aortic and peripheral diseases, local anesthesia minimally invasive treatment of great saphenous vein varicose veins. The new technology and project "Individualized Minimally Invasive Treatment of Lower Limb Great Saphenous Vein Varicose Veins" has been rated as leading in China. In the past five years, I have led and participated in three provincial-level research projects, published more than 10 SCI papers including in JVS and EJVES, and six papers in the Chinese Journal series. I have co-authored one monograph and been granted two patents.
