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Vascular Surgery>Abdominal Aortic Aneu- rysm (AAA). Treat.: Stent Graft System in Patients with Neck Lengths down to 4mm and <=60° Infra-Renal Angulation when used in combination with the "TradeMark B" System.
The Expanded Indication enables the "TradeMark A" stent graft to be used in conjunction with the "TradeMark B" system to treat a wider range of patients with short, hostile aortic neck anatomies, independent of renal stenting.
Until now, some patients with short infra-renal necks (<10mm) were considered ineligible for endovascular aneurysm repair (EVAR), leaving them with limited treatment options. Up to 30 to 40 percent of patients with AAA disease are considered unsuitable candidates for conventional EVAR.1.
According to estimates from physicians across Europe and the United States, more than one-third of these patients have AAA proximal neck anatomies <= 10mm.2.
"Due to the complex and hostile proximal aortic neck anatomy, this patient population remains a challenge to treat,"
"With minimal time added to the procedure, "TradeMark B" fixation has been proven to enhance outcomes and durability, establishing a new treatment approach that addresses this critical patient need."
EU Approval : 2016. 12.
USA FDA Approval: 2017. 10.09.
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UpDate: 2019. 08.10.




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