Surmodics, Inc. (Nasdaq: SRDX) announced the publication of results from the TRANSCEND clinical trial in the March 2025 edition of the European Journal of Vascular and Endovascular Surgery. The global randomized study demonstrated that the SurVeil™ drug-coated balloon (DCB) achieved non-inferior safety and efficacy compared to the IN.PACT™ Admiral™ DCB in treating femoropopliteal arterial disease, despite using a substantially lower paclitaxel dose.
The SurVeil DCB, developed and manufactured by Surmodics and marketed globally by Abbott, features a uniform microcrystalline coating with a 2.0 μg/mm² paclitaxel dose—75% lower than the 3.5 μg/mm² dose used in the IN.PACT Admiral DCB. This significant dose reduction while maintaining comparable clinical outcomes represents an important advancement in DCB technology.
Trial Design and Patient Population
TRANSCEND was designed as the first global head-to-head study comparing different drug-coated balloons. The prospective, multi-center, single-blind, randomized controlled trial enrolled 446 patients with femoropopliteal artery disease (Rutherford stages 2–4) across 65 sites in 9 countries. Patients were randomized to receive either the SurVeil DCB (n=222) or the IN.PACT Admiral DCB (n=224).
Professor Marianne Brodmann, M.D., Head of the Clinical Division of Angiology at the Medical University of Graz, Austria, served as co-principal investigator alongside Kenneth Rosenfield, M.D., William Gray, M.D., and Peter Schneider, M.D.
Key Efficacy and Safety Outcomes
The primary efficacy endpoint of 12-month primary patency (freedom from binary restenosis or clinically driven target lesion revascularization) was comparable between the treatment arms: 82.2% for SurVeil DCB versus 85.9% for IN.PACT Admiral DCB.
Similarly, the primary safety endpoint—defined as freedom from device or procedure-related death within 30 days and above-ankle amputation or clinically driven target vessel revascularization within 12 months—showed comparable outcomes: 91.8% for SurVeil versus 89.9% for IN.PACT Admiral.
Non-inferiority was tested using a multiple imputation approach at one-sided alpha 0.025. Secondary outcomes through 24 months post-procedure remained similar between the two groups, further validating the non-inferiority of the lower-dose SurVeil DCB.
Advanced Drug-Delivery Technology
The SurVeil DCB leverages Surmodics' extensive experience in drug-delivery technology, which dates back to the company's development of the coating used on the first drug-eluting stent, the Johnson & Johnson Cypher™ DES.
The proprietary drug/excipient coating was specifically engineered to:
- Enhance drug retention during delivery to the treatment site
- Optimize drug release and retention in the vessel wall
- Maximize drug bioavailability through controlled microcrystalline morphology
- Improve coating consistency and durability to minimize distal embolization of coating particulates
These technological advancements allowed Surmodics to achieve therapeutic efficacy with a significantly reduced drug dose, potentially improving the safety profile while maintaining effectiveness.
Expert Perspectives
"The publication of TRANSCEND demonstrates its high quality of trial design, conduct, and interpretation of results, and establishes a strong evidence base for physician decision-making," said Professor Brodmann. "Surmodics demonstrated confidence in its technology by choosing to conduct the first worldwide pivotal trial versus a high-dose device. The study's global patient enrollment lends added confidence to the generalizability of the results."
Dr. Kenneth Rosenfield, Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital, emphasized the clinical significance: "Peripheral artery disease affects more than 100 million people globally, causing chronic pain and disability while severely burdening healthcare systems. To meet these challenges, we need PAD treatments with demonstrated long-term safety and effectiveness in maintaining lower limb blood flow. The TRANSCEND study shows that the SurVeil DCB is a best-in-class option for treating femoropopliteal arterial disease that minimizes patient exposure to antiproliferative agents."
Regulatory Status and Future Directions
The SurVeil DCB received FDA approval in the United States in June 2023 and CE Marking under the EU Medical Device Regulation (EU MDR 2017/745) in December 2023. Surmodics has completed the collection of 5-year follow-up data in 2024, which may provide additional insights into the long-term safety and efficacy of the lower-dose DCB.
Gary Maharaj, President and Chief Executive Officer of Surmodics, commented on the significance of the head-to-head trial design: "Surmodics' decision to execute a Level 1, head-to-head study against the market-leading DCB speaks to our conviction in the company's scientific know-how and differentiated technology."
The TRANSCEND trial results suggest that optimized drug delivery technology can achieve comparable clinical outcomes with substantially lower drug doses, potentially addressing concerns about systemic paclitaxel exposure while maintaining therapeutic efficacy in the treatment of peripheral artery disease.
