Enrollment in Bolton Medical’s 30 patient Phase I clinical trial has been completed. The trial included six hospitals with the top enrolling centers being Union Memorial in Baltimore, MD, and the University of North Carolina in Chapel Hill. The study was designed to examine the safety and efficacy of the Relay thoracic stent-graft
The Relay stent-graft is constructed of nitinol stents and surgical graft material. It is delivered to the thoracic aorta through a dual sheath, catheter-based delivery system via a small incision in the femoral artery. The stent-graft is designed to overcome the anatomical challenges of the thoracic aortic arch, and specifically, the three dimensional angulations found in the isthmus area. Additionally, it was conceived to accommodate the anatomical changes that often evolve following endoluminal repair. Long segments of thoracic aorta can be easily repaired since the Relay stent-grafts are available up to 20cm in length. The stent-graft system is delivered endovascularly using the Transport delivery system. This dual sheath delivery system is designed to facilitate endovascular navigation and endograft deliverability across some of the most adverse anatomies and tight arch geometries.
Bolton Medical has also received conditional approval from the FDA for a Phase II pivotal trial. This trial is a prospective multi-center non-randomised study designed to enrol 120 patients at a minimum of 25 hospitals. Endovascular outcomes will be compared to surgical repair, traditionally the ‘gold standard’ of care.
Bolton Medical received CE approval for Relay in April 2005, and to date, over 300 patients have been successfully treated worldwide.