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
