Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of 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 the IN.PACT Admiral DCB (Medtronic).
The SurVeil DCB pivotal trial will be among the first trials in the US to compare a next-generation DCB with a commercially-available DCB.
“By providing a head-to-head comparison with today’s market-leading DCB, the TRANSCEND trial will answer clinically important questions about the relative performance of DCBs,” said Gary Ansel, system medical chief of the vascular programme at OhioHealth, Columbus, USA. “DCB therapy for patients with lower extremity PAD is growing rapidly, and while results have been encouraging there is significant room for improvement.”
The SurVeil DCB design 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 concentrations compared to control DCBs.
“Surmodics’ expertise and capabilities in surface technology are evident in the design and pre-clinical performance of the SurVeil DCB,” said Kenneth Rosenfield, section head of vascular medicine and intervention at Massachusetts General Hospital, Boston, USA, and chair of the Surmodics clinical advisory board. “We are excited about Surmodics’ capability to improve on the performance of existing DCBs.”
The SurVeil DCB US early feasibility study met its primary endpoint by demonstrating peak paclitaxel plasma concentrations post-index procedure. Consistent with pre-clinical data, systemic levels were low and cleared rapidly. No safety issues attributed to the product have been reported.
“Surmodics’ decision to pursue the early feasibility study in the USA demonstrated our confidence in the device and we are excited to be moving this into the pivotal trial,” said Gary Maharaj, president and chief executive officer of Surmodics. “The next-generation technology in the SurVeil DCB aims to improve drug transfer and effect on the arterial wall with a lower drug dose and a reduction in the amount of drug reaching tissue outside the area of treatment. We have been extremely satisfied with our pre-clinical and early feasibility study results and look forward to working with our investigators in this trial to further evaluate the safety and efficacy compared to standard-of-care DCB therapy.”