Surmodics has announced significant findings from its TRANSCEND clinical trial, showcasing that the SurVeil™ drug-coated balloon (DCB) performs on par with the industry leader, IN.PACT Admiral™ DCB, while utilizing a substantially reduced dose of paclitaxel. Published in the European Journal of Vascular and Endovascular Surgery, the study underscores Surmodics’ advancements in drug-delivery technology for treating femoropopliteal arterial disease.
Innovative Drug-Delivery Technology
The SurVeil™ DCB features a proprietary microcrystalline coating that enhances drug retention and optimizes release within the vessel wall. This uniform coating differentiates SurVeil™ from competitors, ensuring consistent performance and minimizing the risk of distal embolization. By meticulously controlling the microcrystalline morphology, Surmodics achieved a balance between effective drug delivery and safety, reducing the overall drug load to 2.0 μg/mm² compared to IN.PACT Admiral™’s 3.5 μg/mm².
Global Clinical Trial Success
The TRANSCEND trial, conducted across 65 sites in nine countries, involved 446 patients with varying stages of femoropopliteal artery disease. Results indicated that SurVeil™ DCB maintained a primary patency rate of 82.2% at 12 months, closely matching IN.PACT Admiral™’s 85.9%. Safety outcomes were similarly comparable, reinforcing the efficacy and reliability of the lower-dose SurVeil™ DCB.
- SurVeil™ DCB uses 75% less paclitaxel than the leading competitor.
- The trial involved a diverse, global patient population, enhancing result generalizability.
- Consistent coating reduces the risk of particulate embolization.
- Non-inferior performance supports Surmodics’ technological claims.
These findings validate Surmodics’ strategic focus on optimizing drug delivery mechanisms while ensuring patient safety. The use of a lower drug dose could lead to fewer side effects and better patient outcomes, positioning SurVeil™ as a preferred option in peripheral artery disease treatments.
Surmodics’ commitment to innovation is evident in the successful development and global adoption of the SurVeil™ DCB. The company’s rigorous trial design and execution have set a new standard in the medical device industry, demonstrating that high efficacy can be achieved with reduced drug exposure. This advancement not only benefits patients but also enhances the overall treatment protocols for femoropopliteal arterial disease.
Looking forward, Surmodics plans to leverage the TRANSCEND trial results to expand the application of SurVeil™ DCB in other vascular areas and continue improving their drug-delivery technologies. Healthcare providers may consider SurVeil™ DCB as a viable alternative to existing treatments, offering equal or better outcomes with a safer drug profile.
By pioneering lower-dose, high-efficacy drug-coated balloons, Surmodics is set to influence future developments in vascular treatment technologies, ensuring enhanced patient care and potentially setting new industry benchmarks.
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