Regulatory Approvals

The ExoVasc® Personalised External Aortic Root Support is a custom device that is designed and manufactured by Exstent Limited to meet the requirements of each patient. As a custom made device it cannot carry the CE mark. However, the company operates a quality system covering the processes of design and manufacture of the custom made devices and this is designed to meet the requirements of ISO 13485:2016.

The ExoVasc® Personalised External Aortic Root Support 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) – the government agency that is responsible for ensuring that medicines and medical devices are safe and effective.

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.