Results Published From TRANSCEND Study of Surmodics SurVeil DCB

April 22, 2025—Surmodics, Inc. announced the publication of results from the TRANSCEND clinical trial.

The global randomized study demonstrated that the company’s SurVeil drug-coated balloon (DCB) is noninferior to the In.Pact Admiral DCB (Medtronic) for safety and efficacy in patients with femoropopliteal arterial disease, while using a substantially lower drug dose than the In.Pact Admiral device, stated the company.

The findings were published by Professor Marianne Brodmann, MD, et al in European Journal of Vascular and Endovascular Surgery (2025;69:452-462).

According to Surmodics, the prospective, multicenter, 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. A total of 446 patients with femoropopliteal artery disease (Rutherford stages 2-4) were enrolled at 65 sites in nine countries and randomized to either the SurVeil DCB (n = 222) or the In.Pact Admiral DCB (n = 224). The company completed collection of 5-year follow-up data in 2024.

As summarized in the press release, the study found the following for the SurVeil DCB versus the In.Pact Admiral DCB:

• The primary efficacy endpoint (12-month primary patency of freedom from binary restenosis or clinically driven target lesion revascularization) was comparable (82.2% vs 85.9%).
• The primary safety endpoint (freedom from device- or procedure-related death within 30 days and above-the-ankle amputation or clinically driven target vessel revascularization within 12 months) was comparable (91.8% vs 89.9%).
• Noninferiority, tested using a multiple imputation approach at one-sided alpha 0.025, was further demonstrated with similar secondary outcomes through 24 months postprocedure.

Coprincipal Investigators of the TRANSCEND study include Prof. Brodmann; Kenneth Rosenfield, MD; William Gray, MD; and Peter Schneider, MD, noted Surmodics.

“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,” commented Prof. Brodmann in the company’s press release. “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. Rosenfield added, “Peripheral artery disease affects more than 100 million people globally, causing chronic pain and disability while severely burdening health care 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.”

Developed and manufactured by Surmodics, the SurVeil DCB is marketed worldwide by Abbott. The SurVeil DCB received the CE Mark under the European Union Medical Device Regulation (EU MDR 2017/74) in December 2023 and received FDA approval in the United States in June 2023, noted the Surmodics press release.