Bolton Medical initiates international clinical trial for Relay PRO and Relay NBS PRO


Bolton Medical has performed its first in-human implantation of its Relay PRO device. The Relay PRO thoracic stent-graft system will enhance the minimally-invasive treatment of patients with thoracic disease due to the lower profile of the delivery device.

The first case was performed by Gianfranco Fadda, director of vascular surgery department at Ospedale San Francesco, Nuoro in Italy. Fadda was very pleased with the performance of the Relay PRO device, in the navigation of the femoral arteries and the stability of the device deployment, both of which are key factors for a successful outcome. Due to the low 19F profile of the delivery system, Fadda was able to complete this case through a percutaneous approach, which eliminates the need for an open incision in the groin.

The regeneration study is led by Vinçenc Riambau at Hospital Clínic de Barcelona. The primary objective of the clinical study is to assess the safety and effectiveness of the Relay PRO and Relay NBS PRO in subjects with thoracic aortic pathologies. The regeneration study will enrol patients at the following hospitals in Spain and Italy: Hospital Clínic de Barcelona, Hospital Germans Trias i Pujol, Badalona, Hospital Marqués de Valdecilla, Santander, Azienda Ospedaliera “S. Giovanni – Addolorata”, Roma,  Ospedale San Francesco Nuoro, and Centro Cardiologico Monzino IRCCS,  Milan. Results of this study will support the approval of the product for CE-mark registration.