We are thrilled to announce that D∙Kaptain PTA High Pressure Balloon Dilatation Catheter has received CE MDR approval! This represents another pivotal step in our journey to revolutionize medical technology, reaffirming our unwavering dedication to innovation, quality, and patient care. Why D∙Kaptain Stands Out: 1. Non-compliant, High RBP at 26atm: For precision under pressure 2. Low Tip Crossing Profile (0.038″): Easy to manoeuvre through challenging anatomy 3. Ultra-short Tapering (<1cm): Reduces trauma to non-target vessels This approval allows us to bring our innovative PTA catheter to healthcare professionals and patients internationally, offering a new solution for effective treatment. We are dedicated to making a positive impact in the medical field and improving lives. Certificate No.: M.2025.MDR.1065

DK MedTech was honored to participate in the recently concluded Japan Endovascular Treatment Conference, and to contribute to discussions during the symposium “Vessel Preparation Asia”, where advanced strategies in vascular intervention—including our innovative DKutting™ Scoring Balloon technology—were explored. A heartfelt thank you to all the interventional experts and distribution partners who took the time to connect—we truly appreciate your insights and collaboration. We also want to extend our sincere congratulations to Dr. Osamu Iida and his organizing committee for orchestrating such a successful and impactful conference. Looking forward to reconnecting soon and continuing the conversation on innovation in vascular treatment!

Following the results of the DELTA trial, DK Medtech is pleased to share that DKutting™ LL Peripheral Scoring Balloon Dilatation Catheter has received double approvals from EU CE MDR and US FDA! As the first head-to-head, large-scale specialty balloon RCT, DELTA compared DKutting™ LL to Chocolate PTA, demonstrating greater acute lumen gain and significantly lower residual stenosis. These compelling findings underscore the precision and effectiveness of DKutting™ LL in vascular intervention. Building on our trusted patented nitinol coiled wire technology—strategically positioned at 120-degree intervals along the balloon—DKutting™ LL is now available for lower extremity arteries, with diameters ranging from 2.5mm to 7mm and lengths up to 150mm, across both 0.014” and 0.018” systems. This milestone reflects our ongoing commitment to clinical evidence, innovation, and improving patient outcomes. A huge thank you to our partners, clinical experts, and the dedicated team behind this success! Link to DELTA RCT: https://lnkd.in/grh8vWbi CE MDR Certificate No.: MDR 816124 R000 510(k) No.: K242254  

Suzhou, China — Recently, DK Medtech (Suzhou) Co., Ltd. (hereinafter referred to as “DK Medtech”) announced that its independently developed DKutting® Scoring Balloon Dilation Catheter has successfully obtained the EU CE MDR certification (CE: M.2025.MDR.1065). This certification marks a significant milestone, enabling the product to enter the EU market and other regions that recognize this certification, and highlights the international recognition of Chinese medical device innovation and product quality. Innovative Design Leads the New Trend in Interventional Treatment The DKutting® High-Pressure Scoring Balloon features a proprietary patented design (CN201810478242.X) with excellent crossability, uniform dilation, and high burst pressure. Since its approval by the NMPA in November 2022, it has been widely praised in peripheral vascular disease and hemodialysis access fields. The innovative “triangular nitinol coil” scoring elements, with a cross-section in the shape of an equilateral triangle, are distributed at 120° intervals and fixed on the balloon working segment. This design prevents slippage during high-resistance stenotic lesion dilation, efficiently embeds into the vascular intima, and provides local high pressure with a rated burst pressure of 20 atm. The patented nitinol coil design also enhances crossability in highly stenotic tortuous lesions by combining longitudinal strength with axial flexibility. Clinical Validation Highlights

Suzhou, China — Recently, DK Medtech announced a significant milestone: its independently developed DK Score™ Coronary Scoring Balloon Dilation Catheter has successfully obtained the CE MDR certification (CE: M.2025.MDR.1062). This achievement signifies that the product has officially gained market access qualifications in the EU and other countries and regions that recognize this certification. DK Score™ Coronary Scoring Balloon Catheter   Innovative Design, Leading the New Trend of Interventional Treatment The DK Score™ Coronary Scoring Balloon is an innovative product of DK Medtech, featuring a unique patented design that offers excellent crossability and directional dilation capability. The scoring elements of this product are made using the “triangular nitinol coil” technology, with a cross-section in the shape of an equilateral triangle. Three scoring elements are distributed at 120° intervals and securely fixed on the balloon working segment. This design ensures that during the dilation of highly resistant stenotic lesions, the scoring elements will not slip. The triangular design can efficiently embed into the vascular intima, coupled with a rated burst pressure of 20 atm, providing the local high pressure required for directional dilation. Moreover, for highly stenotic tortuous lesions, the patented nitinol coil design achieves strong longitudinal strength while maintaining axial flexibility, significantly improving