DK Medical Advances Cardiovascular Intervention with Innovative DK Score® Coronary Scoring Balloon: IPO Filing Highlights Clinical Excellence and Proprietary Technology
DK Medtech
Vascular Interventional Balloon Product Developer
In the field of cardiovascular disease treatment, interventional therapies are playing an increasingly important role. The coronary scoring balloon, as an innovative medical device, has brought new breakthroughs in the treatment of coronary heart disease.
DK Score® Coronary Scoring Balloon Dilatation Catheter, independently developed by DK Medical Technology Co., Ltd. (Suzhou), has gained a significant market position with its unique design and outstanding performance.
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 that the immediate lumen gain in the DK Score® group was 1.12mm, compared to 0.95mm in the control group, with p=0.005, demonstrating a significant statistical difference. Immediate lumen gain is one of the key indicators for evaluating balloon dilation effectiveness; a greater immediate lumen gain indicates a more effective improvement in vascular stenosis during the procedure, increasing vessel patency and providing better conditions for subsequent blood flow, thereby reducing the risk of postoperative cardiovascular adverse events.
Product Design and Technological Innovation - Made in China
Patented Nickel-Titanium Winding Spring Technology
/ DKmedtech
DK Medtech's DK Score® Coronary Scoring Balloon adopts patented nitinol coil technology, offering numerous advantages.
Nickel-titanium alloy itself possesses excellent flexibility and memory characteristics. In balloon design, the coil structure enables the balloon to provide strong support while exhibiting superior compliance. This feature is particularly crucial for treating highly stenosed and tortuous lesions. In actual clinical practice, tortuous vessels often pose significant challenges for the passage of interventional devices. Cutting balloons may struggle to reach the lesion site smoothly, whereas the DK Score® Coronary Scoring Balloon, with its patented coil design, can easily navigate these complex vascular morphologies. It significantly enhances the balloon's trackability while providing robust radial expansion force, laying the foundation for subsequent lesion treatment.
⬇️The coronary balloon is smaller, so a peripheral balloon is used for the bending demonstration⬇️
The engraved wire is fixed on the surface of the balloon, conforming to the shape changes of the balloon without altering its expansion pattern or effectiveness.
Axial Flexibility with Grooves, Freely Shapeable
Triangular Nickel-Titanium Wound Spring Fixed Notched Component
/ DKmedtech
The scoring element of the balloon working section is the core innovation point of this product.
DK Medtech Utilizes "Triangular Nitinol Coil Spring" Technology to Create Notched Components
All-in-One Preprocessing Selection
/ DKmedtech
For common clinical conditions such as vascular stenosis and small vessels, the key attributes of special balloons focus on expansion force, controlled directional expansion, safety, pushability, crossing profile, and applicability as primary objectives.
DK Medtech, by adopting the No Base Bonding technology, has further reduced the balloon's crossing profile. The scoring elements are fixed on the balloon surface, preventing random tearing caused by the scoring elements becoming detached during expansion. Combined with the patented nitinol coil spring design mentioned earlier in the text, when unexpanded, the scoring elements are embedded within the balloon wall. The non-blade design of the scoring elements reduces the risk of additional damage to the vessel wall, enhancing the safety and convenience of the surgical procedure. This achieves a significant balance between expansion force and safety, enabling safe and efficient dilation. It has demonstrated excellent performance in treating both in-stent restenosis lesions and non-in-stent restenosis lesions.
Directional Scoring ·Top-level Pre-dilation
From the excellent deliverability provided by patented nitinol coil technology to the precise directional expansion achieved by triangular nitinol coil scoring elements, DK Medtech's DK Score® Coronary Scoring Balloon redefines the standard for complex coronary lesion pre-treatment with its "China-original" technological core. Its significant advantages in immediate lumen gain, high device success rate, and broad applicability to both in-stent restenosis and non-in-stent restenosis lesions demonstrated in clinical studies not only offer doctors a more efficient and safer treatment tool but also provide patients facing complex conditions such as highly resistant stenosis and tortuous vessels with better therapeutic options.
