EDEN PRAIRIE, Minn. — Surmodics, Inc. has announced the publication of results from its pivotal TRANSCEND clinical trial, which demonstrated that its SurVeil™ drug-coated balloon (DCB) offers comparable safety and efficacy to the IN.PACT™ Admiral™ DCB, despite using a significantly lower dose of the anti-proliferative drug paclitaxel. The findings, published in the March 2025 issue of the European Journal of Vascular and Endovascular Surgery, highlight the potential for SurVeil to deliver effective treatment for femoropopliteal artery disease while reducing drug exposure.
The TRANSCEND study represents the first global, head-to-head randomized trial comparing two leading DCBs for the treatment of superficial femoral and proximal popliteal artery lesions. Conducted across 65 sites in nine countries, the trial enrolled 446 patients with femoropopliteal artery disease, randomizing them to receive either SurVeil (222 patients) or IN.PACT Admiral (224 patients). Both devices deliver paclitaxel to prevent restenosis, but SurVeil uses a lower dose—2.0 μg/mm² compared to the 3.5 μg/mm² used in the IN.PACT Admiral, a 75% higher concentration.
At 12 months, the study found that SurVeil achieved a primary patency rate of 82.2%, closely matching the 85.9% rate seen with IN.PACT Admiral. Safety outcomes were also comparable, with 91.8% of SurVeil patients and 89.9% of IN.PACT Admiral patients free from device- or procedure-related complications, including death, major amputation, or the need for revascularization. These results confirmed the non-inferiority of SurVeil, using rigorous statistical analysis, including a multiple imputation approach.
The TRANSCEND trial extended follow-up through 24 months, further supporting the long-term safety and efficacy of SurVeil’s lower-dose paclitaxel delivery. Data collection for five-year outcomes was completed in 2024.
“TRANSCEND demonstrates the quality of trial design and execution, providing physicians with robust evidence for decision-making,” said Professor Marianne Brodmann, M.D., Head of Angiology at the Medical University of Graz, Austria, and co-principal investigator of the trial. “Surmodics’ confidence in directly comparing SurVeil to a high-dose device on a global scale adds weight to these findings.”
The SurVeil DCB features a proprietary microcrystalline coating developed by Surmodics to enhance drug retention and release while improving biocompatibility. Unlike traditional DCBs, which may contribute to tissue scarring or distal embolization due to coating particulates, SurVeil’s design aims to optimize drug delivery with a reduced drug load. This approach builds on Surmodics’ long-standing expertise in drug-delivery technology, which dates back to its involvement in the Johnson & Johnson Cypher™ drug-eluting stent.
“This trial sets a new standard by comparing our device against the market-leading DCB,” said Gary Maharaj, President and CEO of Surmodics. “Our scientific innovation and differentiated technology are validated by these results. We thank all the global investigators, particularly Professor Brodmann and the clinical teams, whose dedication made this landmark study possible.”
TRANSCEND was led by a group of prominent vascular specialists, including Dr. Kenneth Rosenfield of Massachusetts General Hospital, Dr. William Gray of Main Line Health in Philadelphia, and Dr. Peter Schneider of the University of California, San Francisco, alongside Professor Brodmann. Dr. Rosenfield emphasized the broader implications of the study, noting that peripheral artery disease affects over 100 million people worldwide and that treatments like SurVeil offer long-term benefits while minimizing drug exposure.
With the publication of TRANSCEND, Surmodics strengthens its position in the vascular treatment space, offering a lower-dose alternative that maintains clinical efficacy and safety for patients with femoropopliteal artery disease.
