Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon.
The 446-patient trial is designed to compare the company’s SurVeil device to Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon as a treatment for peripheral artery disease in the upper leg.
“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,” co-principal investigator Dr. Kenneth Rosenfield said in prepared remarks. “Transcend will be a rigorous level one trial that will answer important questions about DCB technologies.”
The trial’s primary efficacy endpoint is primary patency – a composite of freedom from restenosis and clinically-driven target lesion revascularization after 12 months, the Eden Prairie, Minn.-based company said.
“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,” president & CEO Gary Maharaj added. “We’re thrilled to be underway with Transcend and look forward to working with our investigators to execute an efficient and rigorous pivotal trial.”
