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DKutting® LL Peripheral Scoring Balloon Receives CE MDR and FDA Dual Certifications, Highlighted in Deking Medical's IPO Prospectus

May 15, 2025 09:00 CST Updated 09:00
DK Medtech

Vascular Interventional Balloon Product Developer


Recently, DK Medical Technology Co., Ltd. (hereinafter referred to as "DK Medtech") announced good news about its self-developed DKutting.® LL Peripheral Scoring Balloon Dilation Catheter,Successfully obtained EU CE MDR certification (MDR 816124 R000) and FDA certification (K242254).。On the global stage, where medical technology is constantly innovating and competition is intensifying, every authoritative certification represents high recognition of an innovative enterprise. It also signifies that the product’s safety, efficacy, and quality have reached internationally leading standards, offering higher quality and more reliable treatment options for patients with vascular diseases worldwide.


Innovative Design, Leading the New Trend in Interventional Therapy

DK Medtech's DKutting® LL Directional Scoring Balloon successfully addresses the limitations posed by length restrictions when treating long peripheral occlusive lesions, better meeting the surgical needs of peripheral vessels.

Strong radial force, flexible longitudinal movement, efficient expansion capability, and excellent passability make it a better choice for long-segment lesions in the lower limbs.

Clinically Verified, Demonstrating Superior Performance

Previously, Professor Fu Weiwei from the Department of Vascular Surgery at Zhongshan Hospital, Fudan University, as the principal investigator, initiated a prospective, multicenter, randomized controlled, open-label, non-inferiority study (DELTA RCT: NCT05608655) comparing the treatment effects of two types of special balloons for femoropopliteal artery stenosis. As the largest peripheral special balloon RCT study globally to date, the DELTA study aims to evaluate the efficacy and safety of peripheral scoring balloon dilation catheters or PTA balloons in treating peripheral arterial stenosis or occlusive lesions.

Data details can be viewed by clicking: DELTA Trial Data Details - Special Balloon RCT for Lower Limb Arteries

DELTA Study Results Show That Compared with Chocolate Balloon, DKutting® Directional Notching Balloon Can Provide Better Lumen Gain While Equally Reducing the Risk of Dissection or the Rate of Rescue Stenting.

Global Journey, Serving Patients Worldwide

DKutting® LL Directional Scoring Balloon, specifically designed to address complex lesions in lower limb arteries, features excellent trackability and highly efficient directional dilation capabilities. It is more suitable for long, tortuous lesions, reducing random vascular injury, offering a better choice for patients with lower limb vascular diseases and clinical surgeons.

The dual endorsement of CE MDR and FDA certification not only serves as an authoritative testament to the safety, efficacy, and quality control of the DKutting® LL scoring balloon but also marks that the independent R&D capabilities of DK Medtech have reached an internationally top-tier level. Moving forward, DK Medtech will take this certification as a new starting point, continue to deepen its expertise in the vascular intervention field, accelerate technological innovation and product iteration, and make more high-quality medical achievements benefit patients worldwide, writing an even more brilliant chapter for the cause of human health!



DK Medtech

Since its establishment in 2015, DK Medtech has consistently adhered to innovation as its driving force and has now become a leading Chinese enterprise in the full range of interventional balloon innovations. It has developed more than ten types of balloons, including standard balloons, high-pressure balloons, scoring balloons, and drug-coated scoring balloons. Its product line covers the needs of almost all vascular intervention fields, including cardiovascular intervention, peripheral intervention, and neurointervention. Through its self-developed directional scoring technology, this technology has been applied in coronary scoring balloons, peripheral scoring balloons, and drug-coated scoring balloons. According to published pre-market RCT studies of these products, their clinical performance shows significantly better clinical benefits compared to imported control groups. DK Medtech has achieved excellent results and market position in niche markets and has signed multiple strategic cooperation agreements with well-known foreign enterprises such as Medtronic and Asahi Intecc.