W. L. Gore & Associates, Inc. announced the first implant in the United States of the Gore Excluder in a clinical study for the treatment of a type of aortic aneurysm.
This early feasibility study follows an ongoing Phase 1 clinical study that began in Brazil in 2014.
. The new Gore device is under investigation to provide physicians with an off-the-shelf solution for aortic aneurysms encroaching on or involving the visceral section of the aorta.
“Treating aortic aneurysms involving the visceral segment is extremely challenging, and therapeutic options for these patients are currently limited,” said Michel Makaroun, MD, chief of the Division of Vascular Surgery at the University of Pittsburgh School of Medicine and National Principal Investigator of the study. “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.”
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 catheterization 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 have made substantial progress advancing our branched aortic endograft portfolio,” said Ryan Takeuchi, Aortic Business Unit Leader at Gore. “This recent milestone supports our ongoing commitment to providing a complete portfolio for the treatment of simple and complex aortic disease, enabling clinicians to help patients who previously had limited options.”
Gore’s medical business is based in Flagastaff, AZ Gore is headquartered in Newark, DE.