Updated on 7 June 2016
NASDAQ-listed Lombard Medical Inc has announced that the Australian Therapeutic Goods Administration (TGA) has approved the Aorfix Endovascular Stent Graft for inclusion on the Australian Register of Therapeutic Goods. The TGA has approved the use of Aorfix for the treatment of abdominal aortic aneurysms (AAAs) with aortic neck angulations up to 90 degrees.
"Achieving approval to begin commercial sales of Aorfix in Australia is another important milestone for our company," said CEO Simon Hubbert. "Product shipments will begin immediately as we work with leading endovascular physicians to bring Aorfix to market in this country."
Aorfix is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms (AAAs). When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. Aorfix is the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees.
Aorfix features an exclusive 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 been evaluated in three studies and used in more than 7,000 procedures worldwide. Aorfix received FDA approval in 2013, and is commercially available in U.S., U.K., 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.