Lombard Medical Submits Fifth PMA Module To FDA

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Dec 2010 - 1:00 PDT


Lombard Medical Technologies PLC (AIM: LMT), a medical device company focused on solutions for the $1 billion abdominal aortic aneurysm (AAA) repair market, announces that it has submitted the fifth of six pre-market approval (PMA) modules required for the US approval of Aorfix™ by the U.S. Food and Drug Administration (FDA).

The Company has FDA permission to file the PMA for Aorfix™ in a series of 6 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.

Commenting on the submission, Lombard Medical Chief Executive 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."

Source:
Lombard Medical

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