Today W. L. Gore & Associates, Inc. (Gore) announced the first implant in conjunction with the Gore ARISE Study of the GORE® Ascending Stent Graft, an investigational device and the only endovascular stent graft specifically designed to treat Type A dissections of the ascending aorta. The successful procedure took place on August 14, 2018 at Memorial Hermann Medical Center in Houston, Texas by Anthony Estrera, MD, and Bruce Tjaden, MD, as part of the Gore ARISE Study.
ARISE is the first multicenter, early feasibility study approved by the U.S. Food and Drug Administration (FDA) to investigate the use of a minimally invasive device to treat Type A dissection. The National Principal Investigator is Michael Reardon, MD, from Houston Methodist Hospital. The study initially investigated the use of the GORE® TAG® Thoracic Branch Endoprosthesis (Aortic Extender) in Type A dissection, which is also being evaluated in its own pivotal study to assess safety and effectiveness in treating lesions of the aortic arch and descending thoracic aorta. The new purpose-built GORE Ascending Stent Graft will be used for the remainder of the study to allow investigators to gain a better understanding of how new technology can advance treatment options for this condition.
The GORE Ascending Stent Graft features a precise delivery system that is designed to allow for accurate, controlled deployment in complex anatomies. The delivery system features unique angulation control that gives physicians the option to angulate the device to achieve orthogonal placement to the ascending aorta.
Type A aortic dissection is a tear in the lining of the ascending aorta, above the heart, that creates a second channel of blood flow. It is an emergent condition that requires immediate surgery upon diagnosis. The current standard of care for these patients is open surgery involving a sternotomy— cracking the chest and spreading the two halves of the rib cage apart to gain access to the heart and ascending aorta. This is a very invasive and involved surgery that includes temporarily stopping the heart to prevent blood flow during the surgical repair.
“There is a great need for a less-invasive treatment option for Type A dissections, which are fatal for nearly half of all sufferers within 48 hours of onset,” Dr. Anthony Estrera said. “I’m excited that Gore is breaking ground in this area with the development of the first endovascular device specifically designed to meet the anatomical, curvature, and deployment precision requirements unique to the ascending aorta. This device, upon approval, could provide a treatment option for Type A dissection patients who aren’t suitable for open surgery and a less-invasive treatment for all patients with this condition.”
Not all patients with Type A aortic dissection are suitable for open surgery. The average sufferer of ascending aortic dissention is male and in his early 60s, although it can also affect females and a wide age range and age groups. Risk factors that may complicate open surgery include previous thoracic surgical repair, visceral malperfusion, neurologic deficit, presentation with a concurrent myocardial infarction, cardiac tamponade, obesity, advanced aged, and poor renal, cardiac, or pulmonary function. The Gore study will investigate how an endovascular stent graft, delivered via catheter, may be used to line the dissected portion of the ascending aorta as a less-invasive alternative to open surgical repair. Similar endovascular therapies have proven to reduce the risk of complications and recovery times.
“This device is a major milestone for our growing portfolio of endovascular aortic devices,” said Eric Zacharias, Vascular Business Leader at Gore. “The development and clinical testing of this device are part of Gore’s ongoing mission to provide our physician partners with devices that solve unmet clinical needs that provide treatment options to their patients. The GORE Ascending Stent Graft is a device constructed specifically for the ascending aorta. We’re excited to continue the clinical development of this device and see the future results of this early feasibility study.”
When approved, the GORE Ascending Stent Graft will be part of the growing family of aortic devices that share a mission to effectively treat aortic disease, backed by Gore’s highly rated clinical support team and educational offerings.† The comprehensive portfolio of products includes the Conformable GORE® TAG® Thoracic Endoprosthesis for the treatment of thoracic aneurysms, transections, and Type B dissections; the market-leading GORE® EXCLUDER® AAA Endoprosthesis for the treatment of abdominal aortic aneurysms (AAA); and the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), the first FDA approved off-the-shelf device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).