Surmodics Publishes TRANSCEND Trial Results Showcasing SurVeil™ DCB
Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, has announced the publication of the TRANSCEND clinical trial, a global randomized study demonstrating that the SurVeil™ drug-coated balloon (DCB) is non-inferior to the IN.PACT™ Admiral™ DCB for safety and efficacy in patients with femoropopliteal arterial disease while using a substantially lower drug dose. The findings were published in the March 2025 edition of the European Journal of Vascular and Endovascular Surgery.
Surmodics has been a leader in drug-delivery technology since its development of the coating used on the first drug-eluting stent (DES), the Johnson & Johnson Cypher™ DES. Building on this expertise, Surmodics created the proprietary drug/excipient coating for the SurVeil DCB. This development program focused on enhancing drug-delivery performance by improving drug retention during delivery to the treatment site, optimizing drug release and retention in the vessel wall, and maximizing drug bioavailability by carefully controlling the microcrystalline morphology of the coating.
The uniform microcrystalline coating of the SurVeil DCB is noticeably different from the coatings of other DCBs. Additionally, a focus on coating consistency and durability was made to minimize distal embolization of coating particulates. The ultimate goal was to create a coating that minimizes the drug dose on the balloon while maintaining both a profound therapeutic effect and an excellent safety profile. The TRANSCEND pivotal trial investigated this goal by comparing the Surmodics SurVeil DCB with the market-leading IN.PACT Admiral DCB, which is a high-dose DCB.
Both the SurVeil and IN.PACT Admiral DCBs use coatings with the anti-proliferative drug paclitaxel. The SurVeil DCB has a uniform microcrystalline coating with a 2.0 μg/mm² drug load, designed to enhance the duration and optimize drug delivery. In comparison, the IN.PACT Admiral DCB has a 75% higher drug load (3.5 μg/mm²) than the SurVeil DCB. The SurVeil DCB is developed and manufactured by Surmodics and marketed worldwide by Abbott.
Surmodics designed and conducted TRANSCEND, the first global head-to-head study of DCBs. The prospective, multi-center, single-blind, randomized, controlled study compared the SurVeil DCB and the IN.PACT Admiral DCB for treating superficial femoral and proximal popliteal artery lesions. A total of 446 patients with femoropopliteal artery disease (Rutherford stages 2–4) were randomized to either the SurVeil DCB (n = 222) or the IN.PACT Admiral DCB (n = 224). Patients were enrolled at 65 sites in 9 countries.
The primary efficacy endpoint of 12-month primary patency (freedom from binary restenosis or clinically driven target lesion revascularization) was comparable between the SurVeil DCB and the IN.PACT Admiral DCB (82.2% vs 85.9%). 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% vs 89.9%).
Non-inferiority was tested using a multiple imputation approach at one-sided alpha 0.025. Secondary outcomes through 24 months post-procedure were similar between the two groups, further demonstrating the non-inferiority of the low-dose SurVeil DCB when compared to the IN.PACT Admiral DCB. The company completed the collection of 5-year follow-up data in 2024.
“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 co-principal investigator Professor Marianne Brodmann, M.D., Head of the Clinical Division of Angiology at the Medical University of Graz, Austria. “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.”
In addition to Professor Brodmann, co-principal investigators included Dr. Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital, Dr. William Gray, M.D., System Chief, Division of Cardiovascular Diseases at Main Line Health, Philadelphia, and Dr. Peter Schneider, M.D., Professor of Surgery in the Division of Vascular & Endovascular Surgery at the University of California, San Francisco.
“Peripheral artery disease (PAD) affects more than 100 million people globally, causing chronic pain and disability while severely burdening healthcare systems,” said Dr. Rosenfield. “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.”
“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,” said Gary Maharaj, President and CEO of Surmodics. “We are grateful to Professor Brodmann, Drs. Rosenfield, Gray, Schneider, and all the physicians and research coordinators around the world for their commitment to this first-of-its-kind, groundbreaking clinical study. Special thanks go to Dr. Katharina Kurzmann-Gütl, whose exceptional efforts were instrumental to the study’s publication.”
The SurVeil DCB is a next-generation device utilizing best-in-class technology for treating peripheral artery disease (PAD). It includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. The SurVeil DCB received CE Marking under the EU Medical Device Regulation (EU MDR 2017/745) in December 2023 and FDA approval in the United States in June 2023.
Surmodics is a global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic (IVD) immunoassay tests and microarrays. The company is focused on developing highly differentiated medical devices to address unmet clinical needs, leveraging expertise in proprietary surface technologies, enhanced device design, development, and manufacturing capabilities. Surmodics’ mission remains to improve the detection and treatment of disease. The company is headquartered in Eden Prairie, Minnesota.
