First Patient Enrolled in Gore EXCLUDER Iliac Branch Study

Multi-Center Study to Assess Safety and Effectiveness of GORE® EXCLUDER® Iliac Branch Endoprosthesis for Treatment of Common Iliac Artery Aneurysms (CIAA) or Aorto-Iliac Aneurysms (AIA)

Flagstaff, Ariz. (November 13, 2013) — W. L. Gore & Associates (Gore) today announced that Brian Peterson, MD, from Saint Louis University, enrolled the first patient in the Gore EXCLUDER Iliac Branch Clinical Study, a prospective, multi-center, non-randomized, 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 (CIAA) or Aorto-Iliac Aneurysms (AIA). The patient was treated at St. Anthony’s Medical Center, in St. Louis, Missouri.

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.

Dr. 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 bi-femoral 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 enroll 60 patients at up to 50 sites during the course of this study. The GORE EXCLUDER Iliac Branch Endoprosthesis received CE Mark in October 2013 and is currently available in the U.S. for investigational purposes only.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac, and general surgery. Gore is one of a select few companies to appear on all of the U.S. "100 Best Companies to Work For" lists since the rankings debuted in 1984.

 

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