Medical devices maker Lombard Medical Technologies (AIM: LMT) said today the US Food and Drug Administration (FDA) had accepted and closed the first of four modules covering FDA required preclinical testing for Aorfix, a flexible stent graft used for treatment of abdominal aortic aneurysms.
The company’s pre-market approval (PMA) filing plan for the device includes a total of six modules, including the four pre-clinical testing modules, with the remaining three scheduled for submission before the end of H1 2010. The manufacturing approval and clinical data modules are slated for submission in H2 2010 and Q4 2010 respectively, allowing Lombard to complete the PMA application.
The review timeframe for each module is 90 days.
Lombard is currently working on the next phase of pre-marketing activities to prepare for the launch of the device, the company said in the statement.
The update helped the company to a 3% climb in early trade today.