DingKo Medical's DK Score™ Coronary Scoring Balloon Receives CE MDR Certification

DK Score™ Coronary Scoring Balloon is an innovative achievement of DK Medtech, featuring an exclusive patented design with excellent trackability and directional expansion capability. The product utilizes a "triangular nitinol coil" technology to create scoring elements with an equilateral triangular cross-section, where three scoring elements are distributed at 120° and firmly fixed on the balloon working segment. This design ensures that the scoring elements do not slip during the expansion of highly resistant stenotic lesions, while the triangular shape efficiently embeds into the vascular intima. Combined with a rated burst pressure of 20atm, it comprehensively provides the localized high pressure required for directional expansion. Additionally, for highly stenotic tortuous lesions, the patented nitinol coil design achieves strong longitudinal support while maintaining axial flexibility, significantly improving the balloon's trackability.

In the pre-market clinical study (ClinicalTrials.gov ID: NCT05250193), the largest sample size (n=200) RCT trial in China for pressure-focused balloon catheters, led by Professor Zhou Yujie from Anzhen Hospital, showed results indicating:

• The immediate lumen gain in the DK Score™ group was 1.12mm, compared to 0.95mm in the control group, p=0.005, demonstrating a statistically significant difference.

• The success rate of device usage in the DK Score™ group was 96.0%, compared to 89.7% in the control group.

These excellent data fully demonstrate the superior performance and clinical value of the DK Score™ Coronary Scoring Balloon.

Five Major Complex Lesions, One-Step Solution

The recent CE certification obtained overseas is not only a recognition of the technical strength of DK Score™ Coronary Scoring Balloon, but also an important milestone in DK Medtech's international strategy. The CE certification is a mandatory certification by the European Union for medical devices entering its market for sale. Obtaining this certification means that the product complies with relevant EU regulations and harmonized standards, and qualifies for sales in the EU and other countries and regions that recognize this certification.

In the future, DK Medtech will continue to uphold the concept of independent innovation, constantly research and develop more high-quality medical device products, and provide better medical services for patients worldwide.