FDA approves Lombard Med. Tech.'s Aorfix stent graft for treating highest neck angulation

February 15, 2013 by MassDevice staff

Lombard Medical Technologies lands FDA approval for its Aorfix with indication to treat abdominal aortic aneurysms in challenging anatomies with neck angulations of up to 90 degrees.

Lombard Medical Technologies' Aorfix device

British medical device maker Lombard Medical Technologies (LON:LMT) won premarket approval from the FDA to market its Aorfix flexible stent graft in the U.S.

The FDA win gives Lombard permission to market the Aorfix device in treatment of challenging neck angulations from the range of 0 to 90 degrees. No other devices are indicated by the FDA to treat angulations over 60 degrees, according to the company.

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Lombard hopes to use the win to gain access to the $600 million U.S. AAA treatment market, where it will face some stiff competition from rivals such as Medtronic (NYSE:MDT) and W.L. Gore & Assoc.