Premium Expansion | Dr. Matteo Tozzi: Application of DKutting® Scoring Balloon in Lumen Preparation for Vascular Access Stenosis
DK Medtech
Vascular Interventional Balloon Product Developer
With the rapid expansion of the peripheral vascular intervention market, conventional balloons are prone to complications such as excessive vascular injury, flow-limiting dissections, and hematomas when addressing the growing number of highly resistant stenotic lesions. In contrast, pressure-concentrating balloons utilize cutting/scoring elements positioned between the vessel wall and the balloon's outer diameter during inflation to enhance local pressure and achieve efficient, directional dilation, thereby reducing vascular elastic recoil. This represents a new direction in the development of interventional vascular balloons.
The DKutting® directional scoring balloon, independently developed by DK Medtech, features an exclusive patented design (CN201810478242.X),Nitinol Coiled Spring Notched Component, featuring excellent trackability, uniform expansion, high burst pressure, and directional cutting, among other advantages.The scoring element has a height of 0.36 mm, directly reaching the tunica media to provide optimal conditions for subsequent drug-coated balloon therapy.The comprehensive performance of DKutting® delivers a "top-tier dilation" therapeutic effect for vascular stenotic lesions.
International Certification, Top-Tier Expansion
Dr. Matteo Tozzi, a vascular surgery expert at Varese University Hospital in Italy, highly affirmed the clinical efficacy of DKutting® in the dilation of vascular access stenosis and shared his clinical application experience.
Dr. Matteo Tozzi used a 6 × 40 mm DK Medtech DKutting® scoring balloon to predilate the stenotic lesion. Following adequate dilation, a DCB was deployed to further prolong arteriovenous fistula patency.
Pre-treatment Imaging
Post-Treatment Imaging
Scoring/Cutting Balloon Pretreatment Can Significantly Enhance the Drug Efficacy of DCBs[1]
Japanese researchers used the iliac arteries of 12 healthy white rabbits as a model to compare the efficacy of four treatment modalities: balloon angioplasty (BA), cutting balloon (CB) alone, drug-coated balloon (DCB) alone, and a combined CB+DCB therapy. Histopathological analysis at 14 days post-procedure revealed that the combined CB+DCB treatment group exhibited the largest area of medial smooth muscle cell (SMC) loss and the most pronounced disruption of the internal elastic lamina (IEL).
ConfirmLesion preparation is initially performed using a scoring/cutting balloon. The scoring/cutting elements incise the intima and extend to the medial layer, significantly enhancing DCB drug delivery without increasing the risk of external elastic lamina (EEL) injury.
Figure 1
Figure 1. Representative histological images of the iliac artery obtained 14 days following treatment with balloon angioplasty (BA), cutting balloon (CB), drug-coated balloon (DCB), and combined CB+DCB therapy. The images clearly show areas of smooth muscle cell (SMC) loss, as well as disruption of the internal elastic lamina (IEL, black inner line) and external elastic lamina (EEL).
Figure 2
Figure 2. Histological score of medial smooth muscle cell (SMC) loss. Quantitative analysis of medial SMC loss. (A) Depth of medial SMC loss: highest in the CB+DCB group compared to the other groups. (B) Angular extent of severe medial SMC loss: also highest in the CB+DCB group.
[1]SHIOZAKI M, TORII S, SATO Y, et al. Enhanced Drug Effect With Cutting Balloon Followed by Drug Coated Balloon in a Rabbit Model[J/OL]. Catheterization and Cardiovascular Interventions, 2025, 105(7): 1656-1663.
Expert Profiles
Prof. Matteo Tozzi
University of Insubria and Head of the Vascular Surgery Unit at the University Hospital of Varese, Italy
Dr. Matteo Tozzi is a leading vascular surgery expert in Italy, specializing in hemodialysis access and peripheral vascular diseases. He currently serves as a Full Professor of Vascular Surgery at the University of Insubria, Italy, Deputy Director of the Department of Medicine and Surgery, and Director of Vascular Surgery at the University Hospital of Varese.
One of the earliest interventionalists in Europe to perform endovascular interventions for complex hemodialysis access lesions, specializing in the management of stenosis / occlusion in autogenous arteriovenous fistulas (AVF) and arteriovenous grafts (AVG), with extensive experience in lesion preparation for calcified / fibrotic lesions.
Led multiple international clinical studies, including the clinical application and evaluation of innovative devices such as novel bioresorbable dialysis access grafts, scoring/cutting balloons, and drug-coated balloons.
The team has published multiple high-impact papers on vascular access, covering the entire clinical pathway from access creation and stenosis intervention to long-term patency management, and is recognized as one of the benchmark teams in the European vascular access field.
