Cook’s new endograft - which has received CE Mark approval - utilises an improved delivery system that allows for carefully controlled deployment of the endograft to help ensure proximal conformity to the aortic wall. This innovation offers patients unparalleled safety in endovascular thoracic aortic aneurysm repair, even for procedures where endografts have to be positioned in what physicians consider to be uncommonly tight aortic arches, which are notoriously difficult to properly seal.
In approximately 25% of patients, the aortic arch is exceptionally tight. Many currently-available endografts are too rigid or have sealing stents that lack the radial force to conform correctly to the inner curvature of these tight arches, so that the graft does not seal off the aneurysm properly. As a consequence, surgeons in the past have been forced to remodel the arch with a balloon or use other aids to position the graft to reduce the risk of continued bleeding into the aneurysm and possible rupture, thus making the repair procedure longer and more complex.
With the TX2 Pro-Form’s enhanced delivery system, these measures are no longer necessary. Patients receive a potentially safer, more effective procedure, and physicians have a more efficient and controllable treatment option due to the reduced procedural time that the TX2 graft with Pro-Form permits.
"Using the TX2 Pro-Form," said Kolvenbach, "I was able to seal the patient’s thoracic aneurysm in minimal time and with maximum control.
"The stent’s new delivery system enabled me to place the graft to the precise location desired and fit it perfectly to the walls of blood vessel. With this stent graft system we have reached a new level of safety in thoracic aortic aneurysm repair."
The operation was performed on a 72-year-old male patient, who was not considered a suitable candidate for open surgical repair, using endovascular techniques.
The physicians inserted a guide wire through a small incision in the groin to gain access to the femoral artery, then moved the delivery system carrying the stent graft precisely into position over the guide wire, where the device was deployed to treat the aneurysm.
Phil Nowell, global leader of the aortic intervention business unit of Cook Medical, said: "Our aim is to provide surgeons with the best technology to treat patients with the greatest degree of control available in the industry.
"Through continuous product advancement in partnership with some of the world’s leading vascular surgeons, we are thrilled to introduce this industry-leading advance in treating thoracic abdominal aneurysms. 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. We believe this improvement is a significant leap toward the solution of that problem."
