Lombard Medical Technologies, a medical device company focused on abdominal aortic aneurysm (AAA) repair market, has submitted the fifth of six pre-market approval (PMA) modules required for the approval of Aorfix by the US Food and Drug Administration (FDA).
Lombard Medical had FDA permission to file the PMA for Aorfix in a series of 6 modules and the first three of the modules, on biological testing, non-clinical laboratory studies and sterilisation and packaging, have already been reviewed and accepted by the FDA.
The fourth module on bench testing and shelf life was submitted in November and the penultimate module on manufacturing has just been submitted and the final module containing the clinical data is expected to be filed in the first half of 2011.
Lombard Medical chief executive John Rush said they set out clear timelines for submission of the PMA modules required for FDA approval of Aorfix earlier this year and they remain firmly on track to achieve them.
"We look forward to submitting the final PMA module demonstrating the clinical evidence for the use of the Aorfix stent graft in the treatment of complex tortuous anatomy during the first half of 2011," Rush said.