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Grafts Outside the United States
Introduction
The market of aortic endografts is in continuous development. Several endografts that have gained the CE mark are under investigation by the FDA before launching in the U.S. market. This chapter describes their peculiarities and the evidence acquired with the use of these endografts. Since the majority of the devices described in this chapter have been recently introduced, the evidence on the feasibility of their use in the treatment of aortic aneurysm is limited. The available data report of short-term results in terms of patency, freedom from Types I and III endoleak (EL), and freedom from aneurysm sac enlargement is comparable to those of devices that have been longer in use ( Table 12.1 ).
Table 12.1
Complication rates in comparison with devices already present on the United States market. Follow-up duration in brackets.
| Freedom from endoleak Type I/III | Endograft patency | Freedom from sac enlargement | |
|---|---|---|---|
| Infrarenal devices | |||
| Anaconda (33±23 months) | 96.7% | 94.4% | 96% |
| Incraft (48 months) | 97.4% | 97.6% | 89.7% |
| E-vita/E-tegra (10 months) | 100% | 94.7% | 100% |
|
98.9% | 99% | 91% |
|
95.2% | 99.6% | 87.9% |
|
100% | 98.8% | 94% |
| Fenestrated devices | |||
| Anaconda fenestrated (11 months) | 100% | Not reported | 100% a |
|
100% | 100% | 95.5% |
Descriptions of the Devices
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