The Department does not centrally hold the requested data in relation to the prevalence of physician-modified products used in the treatment of abdominal aortic aneurysms (AAA). Any device used in the National Health Service must have a CE mark and suppliers must meet the standard set by the procurement framework.
NHS England has advised that “physician-modified” devices usually refer to stent grafts that have windows or extra windows (fenestrations) cut into them by a surgeon or radiologist. They are usually used in an emergency setting in critically ill patients in order to produce an endovascular solution to save life where no alternative treatment is deemed possible or feasible. NHS England has advised that the number of cases is very small and confined to a few specialised centres.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the NHS, and has been asked to develop a guideline on the diagnosis and management of AAAs.
NICE’s guidance is based on a thorough assessment of the available evidence and is developed through extensive engagement with stakeholders. NICE has not yet published its final guideline on AAA and has recently consulted publicly on its draft guideline. NICE has advised that its draft guideline makes no reference to “non-authorised” products. NICE is considering the comments received during the consultation period and expects to publish its final recommendations to the NHS in November 2018.