UK vascular device company Lombard Medical Technologies PLC, has announced that it has received written feedback from the U.S. FDA on the pre-market approval (“PMA”) application for Aorfix™, the Company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms (“AAAs”).
It tells you something about the significance of gaining FDA approval when a company issues an excitable statement updating the world with recent correspondence with the agency. For Lombard Medical of course, being a listed company, gaining FDA PMA approval is massively material so, when it appears on the horizon, it needs to be communicated. It must be reassuring to be receiving positive vibes from over the pond, especially when those vibes take the form of a short list of questions, which the company believes will be relatively straightforward to address.
In addition, the FDA has also scheduled a Good Manufacturing Process (GMP) 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.
The Company continues to anticipate FDA approval of Aorfix in the fourth quarter of 2012 although with elements of the process being outwith Lombard’s direct control there remains a risk that approval of Aorfix may slip into the first quarter of 2013.
The big deal here is the indication statement. Lombard Medical is seeking the U.S. approval for Aorfix to include 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 U.S. market and the only endovascular stent graft licensed for use in high angle (>60 degrees) cases.
The Company estimates that the US market for the endovascular repair of AAAs is worth over $600 million, is forecast to grow at approximately 8% p.a., and that approximately 30% of all patients have some tortuosity either at the neck of the aneurysm or in the iliac arteries. It is to this segment of patients that Aorfix is targeted with its uniquely flexible design.
CEO of Lombard Medical Technologies, Simon Hubbert, commented: “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.”
Source: Lombard Medical, PLC