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Lombard holds on to Q4 US approval for Aorfix despite FDA questions

This article was originally published in Clinica

Executive Summary

The US FDA has requested from Lombard Medical Technologies responses to some questions raised during the review of the latter's premarket approval application for Aorfix, the UK company's stent graft for the endovascular repair of abdominal aortic aneurysms. London-based Lombard said that the "short list" of questions were "relatively straightforward" and intends to submit its answers to the FDA before the end of the month. The company said it still expects Aorfix to clear the US regulatory hurdle within the fourth quarter, although the approval process may be subject to delays beyond its control and there is "a risk" approval for Aorfix "may slip into the first quarter of 2013".

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