Following a successful audit in September with notified body BSI, Exstent has been recommended for approval to receive the EU MDR Conformity Assessment Certification.
Following a successful surveillance audit in September with notified body BSI, Exstent has been recommended for approval to retain its MDSAP and ISO13485:2016 certification.
Conal Austin gave an interview on the Today programme on Radio 4 on 31 October 2023 discussing the PEARS procedure performed on Saracens rugby player Nick Iskiewe.
Dr Guido Michielon, director of cardiac surgery at Istituto Giannina Gaslini, has successfully carried out the first Ross PEARS surgery in Genoa, Italy.
The patient was a 23-year-old with congenital aortic valve disease associated with dilatation of the ascending aorta and aortic root.
You can read more about the operation in Primocanale.it.
On 29 June 2023, Conal Austin and John Pepper presented on PEARS at the Barts Aortovascular Symposium 900.
The two-day in-person international conference, which ran 29-30 June 2023, targeted all multidisciplinary professionals involved in the care of patients with aortic valve and aortic pathology including acute aortic dissection.
The Symposium was part of the celebration of 900 years of St. Bartholomew’s Hospital, London.
The full programme for the conference can be found at bartsaortovascularsymposium.org.uk/programme/.
Alastair Graham, Cardio-Thoracic surgeon at Royal Victoria Hospital, Belfast, and Tal Golesworthy, Technical Director, Exstent Limited, are presenting on ‘Aortopathy and Marfan’s – The Lived Experience’ at 36th South West Acute Hospital Annual Cardiology Update, a meeting of the Irish Cardiac Society in Irvinestown on 23 June 2023.
For more information, visit irishcardiacsociety.ie/events/36th-south-west-acute-hospital-annual-cardiology-update/
The SME Awards by SME News celebrate the success stories of one of the most important sectors in the UK economy. At the start of 2017, small businesses accounted for 99.3% of all private businesses, making the sector the beating heart of the UK economy. An SME is a small or medium-sized enterprise. Typically, they are defined as having fewer than 250 employees and a turnover of less than €50 million according to the EU.
Exstent was nominated following receipt of its ISO13485:2016 and MDSAP certification.
For the full story, visit www.sme-news.co.uk/winners/exstent-limited/.
Since February 2022, Exstent has been employing the MasterControl electronic Quality Management System software to manage its quality documentation and for completing its device history records. The implementation of this system has had a significant impact on Exstent being able to demonstrate control of its systems to external auditors, leading to Exstent achieving its ISO13485:2016 and MDSAP registration.
Gina Phillips, Exstent’s QARA Controller, collected the award on behalf of Exstent at the 2023 MasterControl Conference in Lisbon.
Ana Redondo is presenting on “Our 7-Year Experience Supporting the Ross Autograft with the Novel Technique of the Personalised External Aortic Root Support” at the 103rd Meeting of the American Association for Thoracic Surgery (AATS), 8 May 2023 in Los Angeles, USA. The presentation by Ana Redondo and Conal Austin reviews the experience at Evelina Children’s Hospital, London over the past 7 years with the PEARS graft when used in conjunction with the Ross operation. For more information, visit https://www.aats.org/resources/our-7-year-experience-supporting-the-ross-autograft-with-the-novel-technique-of-the-personalised-external-aortic-root-support