Bolton Medical has completed patient enrolment for the Regeneration Clinical Trial in Europe. This clinical trial will pave the way for final data evaluation and support the company’s application for the CE mark of RelayPro—Bolton’s low profile thoracic stent-graft system.
The Regeneration Trial will evaluate the safety and effectiveness of the RelayPro device as indicated in 31 patients for the treatment of thoracic aorta pathologies of the descending thoracic aorta. There were a total of eight clinical sites located in Spain and Italy.
“We are excited to see the completion of this trial,” says John Canning, chief operating officer. “Leveraging the foundational technology in RelayPlus, our goal was to design a thoracic stent graft system which would deliver the same control and accuracy but in a smaller profile. No two patients are alike and that is why we strive to offer a solution that caters to the patient and procedure.”