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June 8, 2016
Lombard Medical's Aorfix EVAR Device Approved in Australia
June 9, 2016—Lombard Medical, Inc. announced earlier this week that the company’s Aorfix endovascular stent graft has been approved by the Australian Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods. The TGA has approved the use of Aorfix for the treatment of abdominal aortic aneurysms with aortic neck angulations up to 90º.
According to Lombard Medial, the Aorfix endovascular stent graft system is intended to treat infrarenal aortic and aortoiliac aneurysms. When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. The device features a helical and circular design that allows it to conform to the natural contours of human anatomy, including aortic necks with high angulations and iliac arteries with extreme bends.
Aorfix has received global approvals for the treatment of patients with aortic neck angulations up to 90º. It is commercially available in United States, United Kingdom, Germany, Spain, Italy, Austria, Switzerland, the Czech Republic, Russia, Greece, Canada, Mexico, Brazil, Japan, Hong Kong, Poland, New Zealand, Argentina, Sweden, Colombia, Ireland, Chile, Peru, Uruguay, and now Australia, advised the company.
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