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 updated its guidance to the NHS in England, Wales, Scotland and Northern Ireland on External aortic root support in Marfan syndrome in May 2022. To read the guidance visit https://www.nice.org.uk/guidance/IPG724.
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. The company operates a quality system that meets the requirements of ISO 13485:2016 covering the processes of design and manufacture of the custom made devices. Download a copy of the certificate.
Exstent’s Management Quality System also meets the requirements of MDSAP ISO13485:2016. Certificate number is: MDSAP 765323: Design and Development, and manufacture of custom-made implantable vascular prostheses used to provide external support to the ascending aorta for use by cardiothoracic surgeons. This covers QMS approval for Australia, USA, Canada, Brazil and Japan. Download a copy of the certificate.
As a custom made device it cannot carry the CE mark however the Exstent’s Quality Management System has been audited and meets the requirements of the EU MDR 2017/745 Conformity Assessment.
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.