US-based medical device and in-vitro diagnostic technologies provider Surmodics has announced the completion of enrolment in pivotal TRANSCEND clinical trial for the SurVeil drug-coated balloon (DCB).

Surmodics has developed the SurVeil DCB, a drug-excipient formulation for a durable balloon coating, using surface technology for vascular medical devices, to improve the coating uniformity.

According to the medical devices firm, the pre-clinical data of SurVeil DCB showed an evenly transferred and durable drug effect, along with reduced incidence of downstream drug particles, compared to the control drug-coated balloon.

Surmodics president and chief executive officer Gary Maharaj said: “Completing enrollment in the TRANSCEND trial marks an important milestone and brings us one step closer to bringing this next-generation treatment to PAD patients.

“I would like to thank our Principal Investigators—Dr. Kenneth Rosenfield, Professor Marianne Brodmann and Dr. William Gray—our trial advisor, Dr. Peter Schneider, and the entire Steering Committee for their leadership and guidance, all our investigators, support teams and, importantly, the patients we enrolled. Without their participation, we wouldn’t be here today.”

The study to test safety and efficacy of the SurVeil DCB

The TRANSCEND trial is a randomised study to evaluate the safety and efficacy of the SurVeil DCB compared with a commercially available DCB in treating peripheral artery disease (PAD) in the upper leg.

The study has enrolled a total of 446 patients at 65 sites across the world, and the results of the trial are expected to include long-term, patient-level data out to five years.

PAD is an often underdiagnosed circulatory disorder caused due to accumulation of arterial plaque, most commonly in the legs. It increases the risk of coronary artery disease, heart attack and stroke, and may lead to limb amputation, if left untreated.

TRANSCEND study principal investigator Kenneth Rosenfield said: “TRANSCEND is a rigorous level one, randomized 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.”

In February 2018, the company entered into an agreement with Abbott to provide the latter with exclusive worldwide commercialisation rights for the SurVeil DCB.

After the receipt of the regulatory approval for the device, Surmodics will be responsible for manufacturing clinical and commercial quantities of the product.