Dingkang Medical's DKutting™ LL Peripheral Scoring Balloon Catheter Receives NMPA Approval

As the elderly population in China continues to grow, the number of patients with peripheral vascular diseases is also on the rise. It is predicted that by 2030, the total number of people with peripheral artery disease in China will reach 62.3 million. With the widespread acceptance of the concept "intervention without implantation," "vessel preparation," which ensures the long-term effectiveness of drug-coated balloons, has gained increasing attention. DKutting™ LL Directional Scoring Balloon, as a powerful tool for thorough pre-treatment, will provide a new therapeutic option for lower limb arterial intervention.

DKutting™ LL adopts DK Medtech's unique patented triangular nitinol coil technology, combined with the actual clinical needs of lower limb arteries. It significantly increases the length of the scoring element (up to 150mm) and develops a brand-new fully coaxial balloon delivery system compatible with 0.014”/0.018” guidewires, enriching the selection of balloon diameters at 0.5mm intervals.

DK Medtech's exclusive directional scoring balloon boasts comprehensive performance with robust radial expansion and flexible axial bending. Its clinical performance has been widely recognized in both the coronary and hemodialysis access fields. The newly developed DKutting™ LL scoring balloon is specifically designed for lower extremity arterial interventions, demonstrating significant clinical advantages in directional expansion mechanisms and setting a new standard for peripheral vascular pre-dilation.

By the Department of Vascular Surgery, Zhongshan Hospital, Fudan UniversityProfessor Fu WeiguoThe DELTA study (clinicaltrials.gov ID NCT05608655), led by DK Medtech, is the largest peripheral specialty balloon comparative study in the world and also the first global study comparing against Medtronic's Chocolate.^®Head-to-Head Study of Balloons: The results of the study, globally premiered at LINC2024, show that the DKutting™ LL Scoring Balloon is similar to the control group in reducing the risk rate of dissection and stent rescue rate, and performs better in lumen gain and reduction of residual stenosis. The results of the DELTA study show that the DKutting™ LL Scoring Balloon has the dual characteristics of "high expansibility" and "low injury," making it the preferred versatile balloon for "vessel preparation."

DKutting™ LL Scoring Balloon, born in China, serves patients worldwide and will become an important tool for lower limb arterial pre-treatment.

Since its establishment in 2015, DK Medtech has consistently adhered to innovation as its driving force and has become a leading Chinese enterprise specializing in the full range of interventional balloon innovations. The company 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 nearly all demands in the field of vascular intervention, including cardiovascular, peripheral, and neurovascular interventions. Through its self-developed directional scoring technology, which is applied in coronary scoring balloons, peripheral scoring balloons, and drug-coated scoring balloons, the clinical performance of these products, according to published pre-market RCT studies, shows significantly better clinical benefits compared to imported control groups. This has enabled DK Medtech to achieve outstanding results and a strong market position in niche markets. Additionally, the company has signed multiple strategic cooperation agreements with well-known foreign enterprises such as Medtronic and Asahi Intecc.

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