Physicians performing thoracic endovascular repair (TEVAR) now can achieve even greater levels of control during endograft deployment compared to the original TX2 device with Cook Medical’s new Zenith® TX2® TAA Endovascular Graft with Pro-Form™. Cook’s new TX2 Pro-Form endograft, which has now obtained FDA approval, utilizes an improved delivery system that allows for carefully controlled deployment of the endograft to help establish proximal conformity of the device to the aortic wall. This innovation in endovascular TAA repair was engineered especially for procedures in which endografts must be positioned in tight aortic arches that are notoriously difficult to seal properly.
“Cook is committed to being the technological leader in advanced devices for the treatment of aortic disease from the arch to the iliacs,” explained Phil Nowell, global business unit leader for Cook Medical’s aortic intervention division. “Many physicians are familiar with the relatively common problem of thoracic endografts forming a ‘bird’s beak’ gap along its underside when the graft is deployed into a tight aortic arch. With FDA approval of the Zenith TX2 TAA Endovascular Graft with Pro-Form, Cook is bringing an even more advanced version of its thoracic device to the U.S. market that addresses the need for highly controlled deployment, one of the most significant issues facing physicians performing TEVAR today.”
Thoracic aortic aneurysms (TAAs) occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon, often caused by a hardening of the arteries, high blood pressure or trauma. Aneurysms in the thoracic aorta can result in severe internal bleeding and are potentially fatal; untreated, five-year survival is estimated at between 10 to 15 percent. Moreover, in approximately 25 percent of TAA patients, the aortic arch, which is formed like a reversed U, is exceptionally tight, making treatment difficult.
Many earlier endografts were too rigid or possess sealing stents that lack the radial force to conform correctly to the inner curvature of tight aortic arches, preventing the graft from properly sealing off the aneurysm. Consequently, surgeons have historically been forced to remodel the arch with a balloon or use other aids to position the graft, in an effort to reduce the risk of continued bleeding into the aneurysm and possible rupture. As a result, these difficult repair procedures are often long and complex. The TX2 Pro-Form’s enhanced delivery system may mitigate the need for such additional measures.
Source: Cook Medical