Oxfordshire-based medical device company Lombard Medical Technologies has updated on the US regulatory process for its lead product - Aorfix stent graft.
Aorfix is an endovascular stent graft specifically designed to solve the problems that exist in treating complex tortuous anatomy which is often present in advanced abdominal aortic aneurysm (AAA) disease.
Aorfix is currently being commercialized in the EU, with a pivotal clinical trial ongoing in the US.
Lombard Medical Technologies has filed five of the six pre-market approval (PMA) modular filings required for the US Food and Drug Administration (FDA) submission and three of these have been accepted by the FDA.
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 submissions 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.
Lombard Medical Technologies continues to anticipate FDA approval of Aorfix between the first and third quarters of 2012.