The first US implant of the Gore Excluder thoracoabdominal branch endoprosthesis has taken place during a clinical study of the treatment of aortic aneurysms involving the visceral branch vessels.
Gustavo Oderich, professor of Surgery, Department of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, USA, performed the procedure as part of an initial feasibility study. The study has FDA permission to enrol up to 10 patients, and will assess the safety of the use of this device for such procedures. This study follows an ongoing phase 1 clinical study which began in Brazil in 2014.
This new device is being investigated in order to eventually offer surgeons a complete, off-the-shelf endovascular product for aortic aneurysms which encroach on, or involve, the visceral part of the aorta.
“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,” says Michael Makaroun, chief of the division of Vascular Surgery at the University of Pittsburgh School of Medicine, USA, and national principal investigator of the study.
Deployed via an intuitive staged delivery system, the device is designed to provide vascular surgeons the ability to reposition the partially deployed graft to aid in selective catheterisation of the branches. With four pre-cannulated portals for placement of stent-graft branches for the visceral branch vessels, the device is intended to enable a faster implantation procedure.
“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,” says Oderich. “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.”