On 15 October, Lombard Medical announced it has received written feedback from the US Food and Drug Administration (FDA) on the pre-market approval application for Aorfix stent graft for the endovascular repair of abdominal aortic aneurysms.
The FDA has provided the company with a short list of questions. Lombard has announced that it intends to submit answers to the Agency within 2 weeks. In addition the FDA has also scheduled a Good Manufacturing Process audit of the company’s UK facility in late October. Such audits are typically part of the final stage of the FDA’s review process.
Lombard Medical is seeking the US approval for Aorfix to include a label indication for the treatment of patients with angulations at the neck of the aneurysm of up to 90 degrees. If achieved, this would give Aorfix the broadest label for such a device on the US market and the only endovascular stent graft licensed for use in high angle (>60 degrees) cases. Such a high angle indication can already be found on the European label for Aorfix.
“We welcome the feedback from the FDA and remain confident of the near term approval of Aorfix in the important US market. The FDA has not raised substantive issues with our application, nor has it required the company to submit additional new clinical data. We intend to submit the requested analyses within two weeks and look forward to the FDA visiting our UK facility for the GMP audit later this month,” said Simon Hubbert, CEO of Lombard Medical.