Enrollment Completed in Pivotal TRANSCEND Clinical Trial for Surmodics' SurVeil DCB
August 28, 2019—Surmodics, Inc. announced that it has completed enrollment in the TRANSCEND pivotal clinical trial for the company's SurVeil drug-coated balloon (DCB).
The randomized TRANSCEND trial, which enrolled 446 patients at 65 global sites, will 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 results of the trial will also include long-term, patient-level data out to 5 years.
The trial's Principal Investigators are Kenneth Rosenfield, MD; Marianne Brodmann, MD; and William Gray, MD.
In the company's announcement, Dr. Rosenfield commented, “TRANSCEND is a rigorous level 1, 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."
Dr. Rosenfield continued, "Beyond the device itself, the new trial design will ultimately provide insight into clinically important questions regarding long-term results. There is great promise that this third-generation DCB will further improve upon current outcomes for this technology and provide additional benefit for clinicians and the patients that they treat.”
Prof. Brodmann, who is the trial’s leading enroller with 44 randomizations, added, “I am excited about the potential of the SurVeil DCB to improve the treatment of PAD. Our focus now shifts to follow-up and monitoring of these patients and the collection of high-quality data.”
In February 2018, Surmodics and Abbott announced an agreement that provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB.
Pursuant to the terms of the agreement, Surmodics received a $25 million upfront payment and will receive a $10 million milestone payment in connection with the completion of patient enrollment in the TRANSCEND trial. Surmodics may earn an additional $57 million for other various product development milestones.
Upon regulatory approval of the device, Surmodics will be responsible for manufacturing clinical and commercial quantities of the product and will realize revenue from product sales to Abbott as well as a share of profits resulting from sales to third parties.
According to Surmodics, the SurVeil DCB includes the company's drug excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. Preclinical data have shown a more evenly transferred and durable drug effect, as well as lower incidence of downstream drug particles compared with the control DCB.
The SurVeil DCB is not available for sale anywhere in the world and is for investigational use only, advised the company.