On 29 June 2011, Lombard Medical Technologies, a medical devices company focused on device solutions for the US$1 billion dollar abdominal aortic aneurysm repair market, provided an update on the US regulatory process for its lead product, the Aorfix stent graft.
The company has filed five of the six pre-market approval (PMA) modular filings required for its FDA submission and three of these have been accepted by the FDA. As announced in April 2011, the FDA responded with questions related to modules four (engineering, bench testing and shelf-life) and five (manufacturing). The company has submitted comprehensive responses to all questions and continues to perform confirmatory bench testing, which will be available later this year.
Module six, the final clinical module, has been prepared for submission and on 2 June 2011, the company completed and submitted its Statistical Analysis Plan (SAP) to the FDA. The SAP is the first part of the module six submission with a review period of up to 30 days. The full module will be filed once review of the SAP has been completed. Following submission, the FDA will have up to 180 days in which to review the final module and respond to the company. The company continues to anticipate FDA approval of Aorfix between the first and third quarters of 2012.