First Implant Completed in Thoracoabdominal Aortic Aneurysm Clinical Study of Gore Excluder Device
January 12, 2016—Gore & Associates announced the first implant in the United States of the Gore Excluder thoracoabdominal branch endoprosthesis in a clinical study for the treatment of aortic aneurysms involving the visceral branch vessels. The new Gore device is under investigation to provide physicians with a complete off-the-shelf endovascular solution for aortic aneurysms encroaching on or involving the visceral section of the aorta, stated the company.
The procedure was performed by Gustavo Oderich, MD, Professor of Surgery, Department of Vascular and Endovascular Surgery at the Mayo Clinic in Rochester, Minnesota. In the company’s press release, Dr. Oderich commented, “We are excited to be a part of this early feasibility study, and we are hopeful that the Gore Excluder thoracoabdominal branch endoprosthesis will prove to be a durable, off-the-shelf option for this patient population. The procedure went very well without technical difficulties. The device offered an excellent alternative in our patient who required incorporation of all visceral arteries due to an exceedingly large aneurysm.”
According to the company, this initial feasibility study has US Food and Drug Administration (FDA) consent to enroll up to 10 patients. The study will assess the safety of the device implantation procedure in the treatment of aortic aneurysms encroaching on or involving visceral branch vessels. This early feasibility study follows an ongoing phase 1 clinical study that began in Brazil in 2014.
Gore stated that the Excluder device is deployed via an intuitive staged delivery system. It is designed to provide vascular surgeons with the ability to reposition the partially deployed graft to aid in selective catheterization of the branches. With four precannulated portals for placement of stent graft branches for the visceral branch vessels, the device is intended to enable a faster implantation procedure.
Michel Makaroun, MD, who is Chief of the Division of Vascular Surgery at the University of Pittsburgh School of Medicine in Pittsburgh, Pennsylvania, serves as National Principal Investigator of the study. Dr. Makaroun stated in the announcement, “Treating aortic aneurysms involving the visceral segment is extremely challenging, and therapeutic options for these patients are currently limited. Through this trial, we are hoping to gather initial evidence to support the use of this device in a patient population that today has limited options for a minimally invasive approach to their aortic repair.”