Lombard Medical Technologies announced on 2 September 2009 that the FDA has accepted and closed the first of six modules of the company’s pre-market approval filing plan for Aorfix. The first module is one of four modules covering FDA required preclinical testing for the device. Preclinical testing covers device material biocompatibility and toxicity, sterilisation, packaging, shelf-life and device functional testing.
The company is planning to submit the next three pre-market approval modules with preclinical testing before the end of the first half of 2010. The company’s manufacturing approval module is set for submission early in the second half of 2010, followed by the clinical data module in the fourth quarter of 2010.
The modular pre-market approval process is designed to assist medical device companies and the FDA to review completed testing while the clinical data is ongoing. It allows for content of the pre-market approval application to be broken into well-delineated components for concurrent assessments by FDA reviewers. The review timeframe is 90 days for each module which is then closed and “accepted”” upon satisfactory review of the data. Each accepted module becomes part of the completed pre-market approval application.
Brian Howlett, CEO of Lombard Medical, commented: “This pre-market approval filing is another important step towards US market approval for our lead product, the Aorfix, which we believe offers significant advantages compared with currently marketed stent grafts for the treatment of abdominal aortic aneurysms. The company is also developing the next phase of Aorfix pre-marketing activities, with the goal of establishing the scientific and clinical reputation of the device and laying down solid foundations for a successful launch post-pre-market approval.”