Surmodics has announced enrolment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to a commercially available DCB treatment.
Up to 446 patients will be randomised 1:1 to receive either the SurVeil DCB or Medtronic’s IN.PACT Admiral DCB at approximately 60 US sites and 18 sites outside the USA.
“Based on the preclinical and early feasibility study results we have seen so far, I am excited about the potential of the Surveil DCB as a third-generation DCB to improve the treatment of PAD,” said Kenneth Rosenfield, section head, Vascular Medicine and Intervention at Massachusetts General Hospital, chair of the Surmodics Clinical Advisory Board and US co-principal investigator for the TRANSCEND trial. “TRANSCEND will be a rigorous level one trial that will answer important questions about DCB technologies.”
The design of the Surveil DCB includes a proprietary drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Pre-clinical data have shown a three to five times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to control DCBs.
“This is a major step in the right direction for Surmodics, as we apply and evaluate our unique technology with the goal of improving clinical outcomes for patients with peripheral artery disease,” said Gary Maharaj, president and CEO of Surmodics. “We are thrilled to be underway with TRANSCEND and look forward to working with our investigators to execute an efficient and rigorous pivotal trial.”