Gore has announced that Brian Peterson, from Saint Louis University, enrolled the first patient in the Gore Excluder Iliac Branch Clinical Study, a prospective, multicentre, non-randomised, single-arm study designed to assess the safety and effectiveness of the Gore Excluder Iliac Branch Endoprosthesis for treatment of patients with common iliac artery aneurysms or aorto-iliac aneurysms. The patient was treated at St Anthony’s Medical Center, in St Louis, USA.
The Gore Excluder Iliac Branch Devices (iliac branch component and internal iliac component) are used in conjunction with the Gore Excluder AAA Endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries.
Peterson commented, “We are pleased to get this important study underway and move closer toward improved iliac artery repair. The low profile design, pre-cannulated branch, and bifemoral delivery system proved beneficial in this first case. We look forward to the results of this important study and their implications for minimally invasive endovascular procedures involving iliac arteries.”
“Providing the best possible patient care and fulfilling unmet clinical needs require constant innovation. Gore is committed to advancing these innovations through collaboration with the clinical community,” added Ryan Takeuchi, Aortic Business unit leader at Gore. “We are excited that endovascular specialists globally are expressing such a high level of interest in the study and in iliac artery repair solutions.”
Endovascular specialists will enrol 60 patients at up to 50 sites during the course of this study. The Gore Excluder Iliac Branch Endoprosthesis received the CE mark in October 2013 and is currently available in the USA for investigational purposes only.