Surmodics Inc.’s drug-coated balloon (DCB) SurVeil is not inferior to the IN.PACT Admiral DCB for safety and efficacy in patients with femoropopliteal arterial disease, even when using a substantially lower drug dose, according to TRANSCEND clinical trial results. The findings were published in the March 2025 edition of the European Journal of Vascular and Endovascular Surgery.¹

Surmodics’ leadership in drug delivery technology dates to the company’s development of the coating used on the first drug-eluding stent (DES), Johnson & Johnson MedTech’s Cypher DES. Surmodics leveraged its portfolio of scientific technology to develop SurVeil DCB’s proprietary drug/excipient coating. This development program aimed to improve drug delivery performance by enhancing 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 coating’s microcrystalline morphology.

The uniform microcrystalline coating of the SurVeil DCB is observably different from the coatings of other DCBs. In addition, intense focus was placed on improving coating consistency and durability to minimize distal embolization of coating particulates. The ultimate goal was to produce a coating that minimized the balloon’s drug dose while maintaining both a profound therapeutic effect and excellent safety profile. The TRANSCEND pivotal trial investigated this goal by comparing the Surmodics SurVeil drug-coated balloon with the market-leading IN.PACT Admiral DCB—a high-dose DCB.

“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,” Surmodics President/CEO Gary Maharaj said. “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.”

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 μg/mm² drug load and is intended to enhance duration and optimize drug delivery. In contrast, the IN.PACT Admiral has a 75% higher drug load (3.5 μg/mm²) than the SurVeil DCB. The SurVeil DCB, developed and manufactured by Surmodics, is 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 TRANSCEND study compared the SurVeil DCB and the IN.PACT Admiral DCB for treating superficial femoral and proximal popliteal artery lesions. Four hundred forty-six 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 enrolled at 65 sites in nine 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 low-dose SurVeil DCB when compared to IN.PACT Admiral DCB. The company completed collection of five-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, Kenneth Rosenfield, M.D., section head for Vascular Medicine and Intervention at Massachusetts General Hospital, Boston; William Gray, M.D., system chief, Division of Cardiovascular Diseases at Main Line Health, Philadelphia; and Peter Schneider, M.D., professor of Surgery in the Division of Vascular & Endovascular Surgery at the University of San Francisco, were TRANSCEND study co-principal investigators.

“Peripheral artery disease affects more than 100 million people globally, causing chronic pain and disability while severely burdening healthcare systems,” Dr. Rosenfield stated. “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 the SurVeil DCB is a best-in-class option for treating femoropopliteal arterial disease that minimizes patient exposure to antiproliferative agents.”

The SurVeil DCB is a next-generation device that uses best-in-class technology to treat 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 in December 2023 and gained U.S. Food and Drug Administration approval in June 2023.

Surmodics develops surface modification technologies for intravascular medical devices and provides chemical components for in-vitro diagnostic (IVD) immunoassay tests and microarrays. Surmodics is pursuing highly differentiated medical devices designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages a combination of the company’s expertise in proprietary surface technologies, enhanced device design, development, and manufacturing capabilities. Surmodics is headquartered in Eden Prairie, Minn.

Reference
¹ Brodmann M, Gray WA, Schneider PA, et al. Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: 24 Month Outcomes of the Randomised TRANSCEND Study. Eur J Vasc Endovasc Surg. 2025;69(3):452-462.