Medical device maker Surmodics has completed patient enrolment for the TRANSCEND clinical trial designed to evaluate its SurVeil drug-coated balloon (DCB).
The randomised trial has enrolled a total of 446 patients in 65 sites across the globe. It will assess the efficacy and safety of the SurVeil DCB in comparison to a commercially available DCB in treating peripheral artery disease (PAD) in the upper leg.
Drug-coated balloons are recognised as a key treatment option to treat PAD caused by a build-up of arterial plaque, most commonly in the legs.
The disease affects an estimated 200 million people globally.
TRANSCEND study principal investigator Kenneth Rosenfield said: “TRANSCEND is a rigorous level one, randomised controlled trial that comes at a very important time for the vascular and interventional community.
“By providing a head-to-head comparison with today’s market leading DCB, this trial will provide data regarding the relative performance of the SurVeil DCB, which represents a new generation of DCB. Beyond the device itself, the new trial design will ultimately provide insight into clinically important questions regarding long-term results.”
Manufactured using a new process to improve coating uniformity, the SurVeil DCB includes a drug-excipient formulation for a durable balloon coating.
In February last year, Abbott signed an agreement with Surmodics for the commercial rights to SurVeil DCB.
Surmodics and Abbott agreed to jointly work on the DCB’s development, clinical trials, and regulatory activities in the US and Europe.
As per the agreement, Abbott will make an upfront payment of $25m, along with an additional $67m in potential milestone payments based on product development.
After obtaining regulatory approval, Surmodics will manufacture and supply clinical as well as commercial quantities of the device.