W. L. Gore & Associates announced the first implant of its ascending stent graft, an investigational device and the only endovascular stent graft specifically designed to treat Type A dissections of the ascending aorta.
The surgery was part of Gore’s ARISE study, the first multicenter, early feasibility study approved by the FDA to 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, according to a prepared statement by Newark, Del.-based Gore.
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 very invasive and involved surgery includes temporarily stopping the heart to prevent blood flow during the surgical repair.
The ascending stent graft was designed for accurate, controlled deployment in complex anatomies, the company said. The delivery system gives physicians the option to angulate the device to achieve orthogonal placement to the ascending aorta.
“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,” said Dr. Anthony Estrera, who performed the surgery with Dr.Bruce Tjaden at Memorial Hermann Medical Center in Houston, Texas. “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.”
The average patient with a Type A ascending aorta dissection is male and in his early 60s, although the condition 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 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 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.