
Vascular Interventional Balloon Product Developer


With the vigorous development of China's peripheral vascular intervention market, common balloons tend to cause complications such as excessive vascular injury, flow-limiting dissections, and hematomas when addressing the increasing number of highly resistant stenotic lesions. In contrast, pressure-focusing balloons utilize cutting/notching components positioned between the inner wall of the blood vessel and the outer diameter of the balloon during expansion. These components enhance localized pressure for efficient directional dilation, thereby reducing vascular elastic recoil and representing a new direction in the evolution of vascular intervention balloons.
DK Medtech's independently developed DKutting™ High-Pressure Scoring Balloon, featuring an exclusive patented design (CN201810478242.X), boasts numerous advantages such as excellent deliverability, uniform expansion, and high burst pressure. In terms of overall product performance, it is referred to as the "hexagonal warrior," marking a significant breakthrough for local enterprises in innovating to surpass top-tier imported products.
DK Medtech Special Release[Professor Yan Feng's Team: A Case of Multiple Intimal Hyperplasia Lesions Treated with a Flipping Sheath in an AV Fistula] 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, enhance technical exchange 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 Multiple Intimal Hyperplasia Lesions Treated with a Flipped Sheath in an Arteriovenous Fistula

Wuxi Second People's Hospital, Yan Feng, Yin Jun
Patient Information
Basic Information:Male patient, 69 years old.
Chief Complaint:More than 4 years of maintenance hemodialysis, with poor fistula function for 1 week.
History of Present Illness:Four years ago, the patient was diagnosed with "Stage 5 Chronic Kidney Disease" at our hospital. An autologous arteriovenous fistula was created in the left forearm, and after the fistula matured, maintenance hemodialysis treatment was initiated and has continued to date, three times per week. During this period, the patient underwent five ultrasound-guided fistula PTA procedures due to venous outflow stenosis and occlusion. One week ago, the patient began experiencing pain at the fistula site during dialysis and reported a weakened thrill upon palpation. For further diagnosis and treatment, the patient visited our hospital and was admitted to the department with "Stage 5 Chronic Kidney Disease, stenosis of the left forearm arteriovenous fistula."
Past Medical History:History of "hypertension" for over 10 years, history of "diabetes" for over 10 years. Denies history of trauma, blood transfusion, and drug/food allergies.
Physical Examination:Physical Examination: A longitudinal surgical scar approximately 8 cm in length is visible at the middle segment of the left forearm. Two puncture scars are visible on the forearm and elbow, with aneurysmal dilation noted at the arterial puncture site; no skin damage is present. Palpation: Skin temperature of both upper limbs is normal. A distinct pulsation can be felt at the arteriovenous fistula anastomosis site and 2 cm above the anastomosis, accompanied by a faint thrill. Auscultation: A unidirectional blowing murmur can be heard at the arteriovenous fistula anastomosis site, and a high-pitched blowing murmur is audible 7-8 cm above the anastomosis.
Admission Diagnosis:
Stenosis of Arteriovenous Fistula;
Chronic Kidney Disease Stage 5, Diabetic Nephropathy, Hemodialysis;
Type 2 Diabetes with Multiple Complications;
Hypertension Grade 3 (Very High Risk).
Previous interventional treatment
Time | Main Treatment Process |
2022-01-18 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (5mm High-Pressure Balloon) |
2022-09-22 | Balloon Angioplasty of Left Forearm Arteriovenous Fistula (5mm High-Pressure Balloon) |
2023-04-09 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (6mm High-Pressure Balloon) |
2023-11-17 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (6mm High-Pressure Balloon) |
2024-06-20 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (6mm High-Pressure Balloon) |
Preoperative Analysis
Preoperative Analysis:The patient has three lesions in the arteriovenous fistula of the left upper limb, with vascular calcification and stenosis at the arterial inlet of the S1 anastomosis, and intimal hyperplasia and stenosis at S2 and S3. The patient has undergone PTA treatment five times in the past. After the last PTA treatment, the effect only lasted for two months, indicating the need to change the treatment method to improve outcomes. This time, consider usingDK Medtech 6.0*40mm DKutting™ High-Pressure Scoring BalloonTreatment.
Surgical Objective:
Main Objectives:Open up the stenotic lesion to meet the blood flow requirements for dialysis.
Secondary Objectives:Prevent rebound, extend the usage time of patients' fistulas, and reduce the number of patient interventions.
Surgical Strategy/Plan:A 6F vascular sheath was inserted via a vertical puncture approach at the aneurysm site of the arterial puncture point of the internal fistula, and the sheath was flipped through the flipping sheath technique.DK Medtech 6.0*40mm DKutting™ High-Pressure Scoring BalloonTreat vascular calcification stenosis at the arterial entrance of the S1 anastomosis, and intimal hyperplasia stenosis at S2 and S3 separately.





Surgical Procedure


Axillary brachial plexus block.




Place the sheath along the blood flow.


Heparin saline priming readyDK Medtech 6.0*40mm DKutting™ High-Pressure Scoring Balloon。

Through the vascular sheathDK Medtech 6.0*40mm DKutting™ High-Pressure Scoring Balloon.

Balloon dilation of S2 segment, pressure 20 atm, each time for 1 min, twice in total.

Balloon dilation of segment S3, pressure 20 atm, each time for 1 min, twice in total.

The inner diameter of S2 after dilation is 3.7mm.

The inner diameter of S3 after dilation is 4.0mm.

Flipping the sheath to address stenosis at the arterial entry of the anastomosis S1.



Click to Watch Video
Follow-up
Discharge Status:Postoperative thrill of the arteriovenous fistula was good, with no abnormal pulsation detected. Postoperative dialysis proceeded smoothly, with a dialysis flow rate of 260 ml/min, and no pain reported at the fistula site during dialysis.
Case Summary
Case Characteristics:The patient has multiple stenoses in the arteriovenous fistula of the left forearm, accompanied by intimal hyperplasia and vascular calcification. The patient has previously undergone PTA treatment five times, with the last dilation lasting less than 2 months.
Preoperative Assessment Key Points:Preoperative comprehensive assessment of the intimal hyperplasia and vascular calcification degree of the patient's fistula vessels to formulate a reasonable surgical plan.
Surgical Strategy/Technical Key Points:It is necessary to fully dilate the hyperplastic intima while also addressing the calcified stenotic lesions.DK Medtech 6.0*40mm DKutting™ High-Pressure Scoring BalloonIt is the optimal choice, with the advantages of high pressure and scoring. Generally speaking, during interventional treatment, the introducer sheath is inserted in a specific direction, usually toward the lesion. However, if there are multiple lesions distributed in another direction relative to the original sheath, it may be necessary to insert another introducer sheath pointing in the opposite direction. The flip-sheath technique can achieve the goal of treating multiple lesions through a single access point, but the operation is relatively difficult.
Device Features / Usage Tips:Select a scored balloon of appropriate size based on the patient's fistula width. Avoid excessively forceful vascular dilation, and ensure accurate positioning when using the scored balloon during the procedure.
References:Expert Consensus on Standardized Operating Procedures for Percutaneous Transluminal Angioplasty of Arteriovenous Fistula Under Ultrasound Guidance (2024).

Expert Introduction

Professor Yan Feng
Surgical Guidance
Director of the Department of Nephrology, Chief Physician. With over 20 years of clinical experience in nephrology, he has published numerous papers in international SCI journals as well as national and core journals in China. Currently, he serves as a committee member of the Internal Medicine Association of Jiangsu Medical Association, a committee member of the Nephrology Physicians Association of Jiangsu Medical Association, and the vice chairman of the Nephrology Association of Wuxi Medical Association.
Expertise: Various types of nephritis, nephrotic syndrome, IgA nephropathy, membranous nephropathy, lupus nephritis, purpuric nephritis, systemic vasculitis, diabetic nephropathy, urinary tract infections, acute and chronic renal failure, blood purification, and surgical procedures related to hemodialysis and peritoneal dialysis, etc.
Professor Yin Jun
Surgeon of This Case
Associate Chief Physician of Nephrology, Doctor of Medicine. Long-term engagement in clinical work and teaching research in nephrology, proficient in the diagnosis and treatment of various primary and secondary kidney diseases as well as blood purification therapy, with particular expertise in the establishment and maintenance of vascular access. Completed advanced training in vascular access at the Department of Nephrology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. Participated in establishing a hemodialysis vascular access team.
Expertise: Establishment and maintenance of AVF and AVG, PTA for arteriovenous fistulas under ultrasound and DSA guidance, diagnosis and treatment of central venous lesions, application of stent placement in vascular access, percutaneous catheter implantation for peritoneal dialysis under ultrasound guidance, etc.

Department Introduction


The Hemodialysis Center of Wuxi Second People's Hospital (Central Hospital Affiliated to Jiangnan University) is one of the earliest units in Wuxi to carry out hemodialysis, focusing on the establishment of an integrated management team for hemodialysis vascular access. It maintains a leading position in the city in areas such as the creation and maintenance of AVFs and AVGs, PTA of arteriovenous fistulas under ultrasound and DSA guidance, diagnosis and treatment of central venous lesions, and the application of stent placement in vascular access. Currently, the hemodialysis center provides regular dialysis for more than 200 patients and treats over a thousand emergency and critically ill patients each year. The center implements personalized dialysis treatment plans for patients, establishes individual records, ensures the quality of dialysis, strictly prevents complications, and improves the quality of life for dialysis patients. Additionally, it enhances patients' understanding of their condition and strengthens self-management through various forms such as science popularization education, WeChat groups, official account updates, free clinics, and home visits. It encourages and helps patients live confidently and happily, earning widespread praise from patients.
