Lombard Medical announced that the US Food and Drug Administration (FDA) has approved the third of six modules of the company’s Pre-market Approval (PMA) filing plan for the Aorfix AAA stent graft.
The company will update the market further in its interim results statement on 23 August 2010. CEO John Rush said: “The results to date are very encouraging and the FDA’s approval of the third PMA module for Aorfix brings us a step closer towards our goal of securing US approval.”
The third PMA module includes information pertaining to sterilisation, packaging and shelf-life of the Aorfix stent graft, and is one of five modules covering FDA-required preclinical testing for the device. Modules one and two, which included information on biological testing and non-clinical laboratory studies have already received FDA approval. The company expects to file the last two non-clinical modules during 2010, with the filing of the final clinical module of the PMA planned for the first half of 2011.