W. L. Gore & Associates, Inc. (Gore) 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 procedure was performed by Gustavo Oderich, MD, Professor of Surgery, Department of Vascular and Endovascular Surgery at the Mayo Clinic, Rochester, Minn. This initial feasibility study, which has FDA consent to enroll up to 10 patients, 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.
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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Photo: Business Wire)
Current treatment options for patients with aortic aneurysms involving the visceral segment are limited. To treat these complex cases, physicians often rely on endovascular devices that are not designed for this purpose or must wait several weeks for a custom device to be built. 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.
“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 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,” said Dr. 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.”
“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.”
The GORE® EXCLUDER® Device and GORE® TAG® Device families are backed by more than 18 years of continuous improvement, 344,000 devices distributed worldwide, and five-year prospective, controlled clinical data.
At Gore Medical, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are 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. For more information, visit www.goremedical.com.
Products listed may not be available in all markets. GORE®, EXCLUDER®, TAG®, and designs are trademarks of W. L. Gore & Associates.
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