Lombard Medical submits fifth PMA module to FDA

Lombard Medical Technologies has submitted the fifth of six pre-market approval modules required for approval of Aorfix by the US Food and Drug Administration.

The company has FDA permission to file the PMA for Aorfix in a series of six modules.

The first three of these 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.

The final module containing the clinical data is expected to be filed in the first half of 2011.

Lombard Medical CEO John Rush said: "We set out clear timelines for submission of the PMA modules required for FDA approval of Aorfix earlier this year and we 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.

"The US is the largest market for AAA stent grafts, worth over $500 million, and we continue to be confident of winning approval for Aorfix in this important market."

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