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Novel Sealing System Nabs CE Mark for Endovascular Treatment of AAA
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Endologix announced that its Nellix EndoVascular Aneurysm Sealing System, the first system of its kind, has received a CE mark for the treatment of patients with abdominal aortic aneurysms.
According to a press release from the manufacturer, the system is designed to simplify endovascular abdominal aortic aneurysm (AAA) repair, treat a broad range of patients and provide enhanced clinical outcomes. On Endologix’s website, the device is said to “completely fill and seal the aortic aneurysm sac, with the aim of preventing device migration and endoleak, and therefore potentially reducing the need for secondary procedures.”
This latest approval includes enhancements to a previous version of the system, which received a CE mark in October 2012. The manufacturer expects to begin a limited market introduction of the system in Europe during the second quarter 2013 and will initiate a postmarket clinical study on the device beginning third quarter 2013 in select European centers.
Currently, the Nellix system is not approved in the United States for either investigational use or commercial sale.