European Regeneration Trial Evaluates Bolton Medical's Relay Pro Systems

October 27, 2014—Bolton Medical announced the initiation of the Regeneration clinical trial that will assess the safety and effectiveness of the company’s Relay Pro and Relay NBS Pro thoracic stent graft systems in patients with thoracic aortic pathologies. The study results will support the company’s application for CE Mark approval of the Relay Pro devices.

Gianfranco Fadda, MD, Director of Vascular Surgery Department at Ospedale San Francesco, Nuoro in Italy, performed the first-in-human implantation of the Relay Pro system as part of the study.

Bolton Medical reported that Dr. 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, which are key factors for a successful outcome. With the low 19-F profile of the delivery system, Dr. Fadda was able to perform this case through a percutaneous approach, which eliminates the need for an open incision in the groin.

The company advised that Vincent Riambau, MD, of Hospital Clínic de Barcelona in Spain, is leading the Regeneration study, which will be conducted in Spain and Italy. The study will enroll patients at three institutions in Spain: Hospital Clínic de Barcelona, Hospital Germans Trias i Pujol in Badalona, and Hospital Marqués de Valdecilla in Santander. In Italy, patients will be enrolled at Azienda Ospedaliera S. GiovanniAddolorata in Rome, Ospedale San Francesco in Nuoro, and Centro Cardiologico Monzino IRCCS in Milan.

Bolton Medical currently manufactures and markets the Relay Plus and Relay NBS Plus thoracic stent grafts and Treovance abdominal stent grafts, which are indicated for the endovascular treatment of aortic pathologies such as aneurysms, dissections, penetrating ulcers, pseudoaneurysms, and intramural hematomas.