
Vascular Interventional Balloon Product Developer


Stenosis of autologous or artificial arteriovenous fistula (AVF/AVG) is the most common complication in hemodialysis patients. Percutaneous transluminal angioplasty (PTA) has become the primary method for maintaining dialysis access. However, the blunt and irregular tearing of the intima and part of the media by traditional balloons during PTA can cause excessive damage to the endothelial vessels, leading to intense proliferation of vascular smooth muscle cells and macrophages, which quickly results in restenosis.
In recent years, there has been continuous international exploration and clinical research on drug-coated balloons and other devices for PTA treatment of dialysis access. DK Medtech has developed the Dissolve™ AV Scoring Drug Balloon, which integrates three features—"scoring," "high pressure," and "drug coating"—and is the world's first third-generation drug balloon:
Directional Scoring: Uniform and regular intimal tearing to reduce blunt dissection injury.
High Burst Pressure: For high-resistance lesions, improving technical success rate.
Paclitaxel Coating: Effectively Inhibits Excessive Proliferation of Smooth Muscle Cells.
DK Medtech Special Release[Professor Huang Ling's Team: Application of Scored Drug-Coated Balloons in Repeatedly Stenotic Dialysis Fistula 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.

Scored Drug Balloons Applied in
Repeated Stenosis of Dialysis Fistula Lesions

Huang Ling, Zeng Lanhui, Hou Pei from the Affiliated Hospital of Jinggangshan University
Patient Information
Basic Information:Female, 55 years old.
Chief Complaint:Repeatedly poor dialysis flow in the internal fistula for 2 years, recurrence in 1 week.
History of Present Illness:Five years ago, the patient was found to have elevated serum creatinine during an examination due to dizziness and fatigue. Subsequently diagnosed with uremia, the patient underwent a left forearm cephalic vein-radial artery fistula surgery and received regular dialysis treatment post-operation. During this period, due to poor dialysis flow, the patient was diagnosed with fistula stenosis and underwent fistula balloon dilation. One week prior to this admission, the patient again experienced poor dialysis flow and was tentatively diagnosed with "arteriovenous fistula stenosis" upon hospital admission.
Past Medical History:A 5-year history of hypertension treated with oral medication.
Physical Examination:A cephalic vein-radial artery fistula is visible on the left forearm, with mild aneurysmal dilation and puncture scars observed on the cephalic vein. The fistula anastomosis can be palpated with pulsation but no thrill.
Admission Diagnosis:Stenosis of arteriovenous fistula, uremia, hypertension.
Previous interventional treatment
Time | Main Treatment Process |
May 2020 | Poor maturation after fistula surgery, balloon dilation performed to promote maturation (at another hospital), femoral vein catheterization for dialysis treatment. |
July 2021 | Stenosis of internal fistula, balloon angioplasty performed (external hospital) |
December 2021 | Occlusion of internal fistula with thrombosis, underwent balloon dilation + thrombectomy (outside hospital) |
August 2022 | Stenosis of the internal fistula, balloon dilation performed (in our hospital) |
February 2023 | Stenosis of the internal fistula, balloon dilation performed (in our hospital) |
November 2023 | Occlusion of the internal fistula with thrombosis, balloon dilation + thrombolysis (in our hospital) |
Preoperative Analysis
Preoperative Analysis:The patient underwent repeated balloon angioplasty for recurrent stenosis of the arteriovenous fistula, with short intervals between procedures. The patient's vascular condition was poor, characterized by thin vessels and reliance solely on the basilic vein for drainage due to the absence of the median cubital vein. Refractory intimal hyperplasia was considered, and conventional balloon angioplasty had shown limited effectiveness.
Surgical Objective:
Main Objectives:Using high-pressure scoring drug-coated balloons to evenly cut the intima, and drug coating to slow the speed of intimal hyperplasia, reducing vascular dissection and elastic recoil.
Secondary Objective:No bleeding or endometrial tearing.
Surgical Strategy/Plan:After DSA-guided balloon angioplasty of the internal fistula.
Surgical Procedure

Puncture of the basilic vein in the elbow for sheath placement and angiography: Severe stenosis of the cephalic vein at the anastomosis of the arteriovenous fistula, no thrombus observed. Decision made to perform balloon angioplasty.

The guidewire passed through the stenotic lesion, crossed the anastomosis, and reached the true lumen of the radial artery.

Two expansions were performed at 20atm+12atm using a 6.0*80mm DK Medtech Dissolve™ AV High-Pressure Scoring Drug-Coated Balloon, with each pressure maintained for 3 minutes to ensure adequate drug adherence to the vessel wall.

After dilation angiography, the stenosis disappeared and the flow velocity significantly improved.
Follow-up
Discharge Status:The patient underwent normal dialysis after the surgery, with no particular discomfort, and the thrill of the arteriovenous fistula was obvious.
Case Summary
Case Characteristics:Long-term dialysis patient with recurrent stenosis of the internal fistula, underwent 6 interventional treatments.
Preoperative Assessment Key Points:Evaluate the cause of recurrent stenosis, considering intimal hyperplasia; understand the characteristics of scoring drug-coated balloons, and select a balloon of appropriate size based on the lesion location, the inner diameter, and length of the vessels surrounding the stenotic area.。
Surgical Strategy/Technical Key Points:Based on the degree of intimal hyperplasia at the stenotic site and the pressure previously used for balloon dilation, appropriate scoring drugs are selected as a reference. The DK Medtech Dissolve™ AV High-Pressure Scoring Drug-Coated Balloon combines the advantages of high pressure, scoring, and drug coating.
Features/Usage Tips of the Device:It is recommended to use a larger sheath for easy insertion and removal of the scoring drug-coated balloon. After the balloon is fully expanded, maintain a holding time of at least 3 minutes to ensure adequate drug adhesion to the vessel wall.
References:
The Role of Drug-Coated Balloon in Haemodialysis Arteriovenous Fistula Stenosis Management.| Kun Da Zhuang 1 , Farah Gillan Irani 2 , Apoorva Gogna 2 , Chow Wei Too 2 , Bien Soo Tan 2 , Kiang Hiong Tay 2
Comparison of drug-coated balloon angioplasty versus common balloon angioplasty for arteriovenous fistula stenosis: A systematic review and meta-analysis.| Yong Zhang 1 , Fan-Li Yuan 2 , Xiang-Yang Hu 3 , Qi-Bing Wang 3 , Zhen-Wu Zou 4 , Zhen-Guo Li 5

Introduction of Experts

Professor Huang Ling
Surgical Guidance
Ph.D. in Surgery, Associate Chief Physician, Associate Professor, Master's Graduate Supervisor. Vice President of the Affiliated Hospital of Jinggangshan University; Director of the Clinical Medical Research Center for Interventional Treatment of Ji'an City; Academic Leader of Surgery at Jinggangshan University; Standing Committee Member of the Ji'an Youth Federation. Honored as an Advanced Medical Worker in Jiangxi Province, the First Outstanding Physician of Ji'an City, and an Advanced Individual by the Ji'an Association for Science and Technology. Chairman of the Vascular Surgery Branch of the Jiangxi Health Care Association; Member of the Vascular Access Group of the Vascular Surgery Branch of the Chinese Medical Doctor Association; Standing Committee Member of the Peripheral Vascular Disease Management Branch of the Chinese Geriatric Medical Association; Member of the Heart Valve Professional Committee of the Chinese Research Hospital Association; Member of the Hemorrhage Professional Committee of the Chinese Research Hospital Association; Member of the Hemodialysis Youth Alliance of the Asia-Pacific Vascular Academic Alliance; Deputy Chairman of the Youth Committee of the Vascular Surgery Branch of the Jiangxi Medical Association; Deputy Chairman of the Vascular Medicine Branch of the Jiangxi Research Hospital Association; Deputy Chairman of the Youth Committee of the Thoracic Surgery Branch of the Jiangxi Research Hospital Association; Standing Committee Member of the Thoracic Surgery Branch of the Jiangxi Medical Doctor Association; Standing Committee Member of the Vascular Surgery Physicians Branch of the Jiangxi Medical Doctor Association; Standing Committee Member of the Pulmonary Vascular Intervention Branch of the Jiangxi Health Care Association; Member of the Cardiac and Great Vessel Surgery Group and the Youth Committee of the Thoracic Cardiovascular Surgery Branch of the Jiangxi Medical Association; Member of the Interventional Medicine Branch of the Jiangxi Medical Association; Member of the Diabetic Foot Group of the Diabetes Branch of the Jiangxi Medical Association; Incoming Chairman of the Interventional Medicine Branch of the Ji'an Medical Association; Standing Committee Member of the Thoracic Surgery Branch of the Jiangxi Medical Association, etc. Associate Editor of "Essentials of Cardiothoracic Surgery."
Zeng Lanhui
Surgeon of This Case
Master, Attending Physician of the Department of Interventional Vascular Surgery at the Affiliated Hospital of Jinggangshan University.
Member of the Grassroots Expert Committee of the Peripheral Vascular Specialty Committee of the Chinese Society of Microcirculation; Member of the Interventional Vascular Surgery Group of the Vascular Surgery Branch of the Jiangxi Medical Association; Member and Secretary of the Vascular Surgery Physicians Branch of the Jiangxi Medical Association. Standing Committee Member of the Vascular Surgery Branch of the Jiangxi Health Care Association; Member of the Pulmonary Vascular Intervention Branch of the Jiangxi Health Care Association; Member of the Interventional Medicine Branch of the Jiangxi Integrated Medicine Association; Member of the Vascular Medicine Branch of the Jiangxi Research Hospital Association; Member of the Oncology Professional Committee of the Jiangxi Rehabilitation and Health Preservation Association.
Expertise: 1. Diagnosis and treatment of common vascular surgical diseases such as aortic dissection, lower extremity arterial sclerosis occlusion, varicose veins of the lower extremities, deep vein thrombosis of the lower extremities, aneurysms, etc.; 2. Interventional maintenance and establishment of hemodialysis access; 3. Interventional hemostasis treatment for hemorrhagic diseases (such as hemoptysis, gastrointestinal bleeding, renal hemorrhage, uterine bleeding, etc.); 4. Interventional treatment of malignant obstructive jaundice; 5. Interventional treatment of solid tumors such as liver cancer, lung cancer, and pancreatic cancer (such as chemoembolization, intra-arterial chemotherapy infusion, microwave ablation, etc.); 6. Diagnosis and interventional treatment of cirrhotic portal hypertension; 7. Interventional treatment of hepatic and renal cysts; 8. Other minimally invasive interventional treatments such as port implantation and maintenance for cancer patients.
Hou Pei
The Operator of This Case
Specialties: Interventional treatment of peripheral vascular diseases and hemodialysis access-related conditions. Completed specialized training at the Vascular Surgery Base of the First Affiliated Hospital of Sun Yat-sen University.
Main Academic Positions: Standing Committee Member of the Vascular Surgery Branch of Jiangxi Province Health Care Medical Association;Member of the Interventional Society Branch of the Jiangxi Province Integrated Medical Association;Member of the Vascular Surgery Branch of the Jiangxi Province Research-Oriented Medical Association;Member of the Pulmonary Vascular Branch of the Jiangxi Province Health Association, Member of the Oncology Professional Committee of the Jiangxi Province Rehabilitation and Wellness Association.

Department Introduction

The Clinical Medical Research Center for Interventional Therapy of Ji'an City was established in March 2022 after being evaluated and approved by the Ji'an Science and Technology Bureau, the Ji'an Health Commission, and the Ji'an Market Supervision Administration. Dr. Huang Ling serves as the head of the center.
The Clinical Medical Research Center for Interventional Therapy in Ji'an City, with the aim of "Minimally Invasive Intervention and Integrated Innovation," is committed to building a top-tier clinical medical center in Jiangxi Province. The center specializes in minimally invasive interventional treatments for tumors and vascular diseases, promoting coordinated development in medical treatment, education, and research. Affiliated with the Affiliated Hospital of Jinggangshan University, the center leverages platforms such as the Critical Care Center (a provincial regional medical center), the Clinical Medical Research Center of Jinggangshan University, and the Expert Workstation of the Affiliated Hospital of Jinggangshan University. With a craftsman's spirit, it continuously optimizes surgical quality and strengthens internal development. Through various academic exchanges and surgical guidance, the center establishes supportive connections with grassroots hospitals, steadily enhancing the treatment and outreach capabilities within related fields in the region.
The center fully carries out diagnosis and treatment work in sub-specialties such as cardiothoracic and great vessel, tumor intervention, and vascular surgery. It was the first in the Ji'an region to perform technologies such as in-situ fenestration for aortic dissection, transjugular intrahepatic portosystemic shunt (TIPS), interventional embolization for massive hemoptysis, carotid endarterectomy, lower limb arterial bypass grafting with artificial vessels, endovenous laser closure of varicose veins under tumescent anesthesia, one-stop thrombectomy treatment for deep vein thrombosis of the lower limbs, balloon angioplasty for dialysis patients' hemodialysis access, and minimally invasive interventional treatments for lung cancer and liver cancer. The center is a core unit of the National Clinical Research Center for Radiology and Treatment, a branch center of the Jiangxi Provincial Clinical Research Center for Interventional Treatment, a council member of the China Hemorrhage Center, and a council member of the Jiangxi Provincial Pulmonary Embolism and Deep Vein Thrombosis Prevention and Treatment Alliance. It has led the establishment of the Vascular Surgery Branch of the Jiangxi Health Care Association, the Interventional Medicine Branch of the Ji'an Medical Association, the Venous Disease Standard Diagnosis and Treatment Training Center, the Lung Cancer Diagnosis and Treatment Integration Center, and the Vascular Access Diagnosis and Treatment Collaboration Group. The center was the first in Ji'an City to be equipped with advanced equipment such as tumor ablation devices, varicose vein ring laser treatment devices, and mechanical thrombectomy devices. The center's director, Vice President Huang Ling, is a member of the Vascular Access Committee of the Vascular Surgery Physicians Branch of the Chinese Medical Doctor Association, a member of the APAA Hemodialysis Access Youth Committee, and an academic leader in the surgical direction of clinical medicine at Jinggangshan University.
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