The ExoVasc® Personalised External Aortic Root Support – PEARS – was the subject of a clinical trial that was approved by the Local Research & Ethics Committee of the Royal Brompton & Harefield NHS Foundation Trust and the UK Medicines and Healthcare products Regulation Agency (MHRA).
In January 2010 the procedure received Clinical Practice Committee approval from the Royal Brompton & Harefield NHS Foundation Trust.
The procedure was submitted to the Interventional Procedures Advisory Committee (IPAC) of the National Institute for Health and Clinical Excellence (NICE). Following a consultation process, NICE issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on External aortic root support in Marfan syndrome in May 2011. To read the guidance visit http://guidance.nice.org.uk/IPG394.
The ExoVasc® Personalised External Root Support has not yet received clearance by the US Food and Drug Administration and is thus not available for use in the USA at this time.
The PEARS project has a highly skilled and well-respected team of clinical advisors. They are all recognised experts in their field. Find about the PEARS project clinical advisors.
The ExoVasc® Personalised External Aortic Root Support has been developed by Exstent Limited.