Cook Medical has received FDA approval to market the Zenith TX2 TAA Pro-Form endovascular graft.
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.
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.
Product page: Cook Zenith….