In the last week, two peer-reviewed clinical papers on ExoVasc® have been published discussing the observed desired clinical outcomes of the PEARS procedure.
The first ‘Personalised external aortic root support for elective treatment of aortic root dilation in 200 patients’, by Lucas Van Hoof et al, published in Heart, Journal of the British Cardiovascular Society, discusses the results of a clinical study performed on the first 200 consecutive ExoVasc patients following implantation at 23 different centres between 2004 and 2019. Based on 596 postoperative patient years, it concludes that PEARS has a low operative mortality and that aortic dissection has not been observed to date in the part of the aorta restrained by the ExoVasc® PEARS implant.
The second ‘Personalized External Aortic Root Support (PEARS) for Aortic Root Aneurysm’, by Louise A Kenny et al, published in Operative Techniques in Thoracic and Cardiovascular Surgery: A Comparative Atlas, describes the preoperative planning and surgical technique for the ExoVasc® Personalised Aortic Root Support with detailed illustrations. It also concludes that following implantation in 384 patients, the author is not aware of any patient with aortic dissection or rupture following PEARS.
Exstent Limited has completed its relocation to new premises on Tewkesbury Business Park. The larger facility is equipped with a more spacious cleanroom for the production of ExoVasc® Personalised External Aortic Root Support implants, and accommodates the enlarged team as the company meets the growing demand for this innovative device.
We are pleased to announce the appointment of Victoria Sharpe as the new Managing Director of Exstent Limited. Victoria is a Chartered Engineer with a wealth of experience in the medical device industry and will lead the company through the next phase of its growth.
The Brisbane-based Courier-Mail carries a three page article describing how a patient with Marfan syndrome became the first to undergo repair to her dilated aortic root during pregnancy. The ability to perform PEARS surgery without the use of cardiopulmonary bypass reduced the risk to her unborn child. Five months later the patient gave birth to her healthy daughter.
The July issue of the British Journal of Cardiology carries a report on a multicentre study of 117 consecutive patients who received ExoVasc mesh implants for aortic root aneurysm from 2004 to 2017. The report concludes that the operation achieves the objectives of valve-sparing root replacement, and it is seen as a low-risk conservative operation which is complementary to more invasive procedures, such as valve sparing root replacement or total root replacement.
On 15 November 2019 an ExoVasc PEARS surgical workshop was held in Prague with presentations from four UK surgeons and Czech surgeons and cardiologists who are involved with the PEARS programme. Clinical data was presented as well as case reports on ExoVasc PEARS recipients. At the end of the workshop, a live questionnaire was run concerning various technical aspects of the manufacture and implantation of the ExoVasc.
Exstent participated in the 33rd Annual Meeting of the European Association for Cardio-Thoracic Surgery, which took place in Lisbon, Portugal, 3-5 October 2019. The company also had a stand at the associated exhibition.
The 7 News channel in Australia reports on the introduction of the ExoVasc PEARS procedure at the Prince Charles Hospital in Brisbane in which surgeon Olivia Williams describes the PEARS procedure as ‘one of the most important advancements to have occurred in cardiac surgery over the last couple of decades.’
You can watch the video by clicking on the image below.
On Friday 24 May 2019, Tal Golesworthy celebrated the 15th anniversary of receiving his ExoVasc® Personalised External Aortic Root Support.
His aorta remains dimensionally stable and fully functional without aortic regurgitation, aortic dissection, aortic rupture, or the need for any form of drug intervention.
Since Tal’s implant in 2004, PEARS has successfully treated asymptomatic aortic dilation in 210 patients with Marfan Syndrome, Loeys-Dietz Syndrome, Bicuspid Aortic Valve Disease and various other idiopathic diseases. There are 657 patient-years’ post-operative experience and four female patients have had five uneventful pregnancies and deliveries. PEARS surgery is offered by 23 surgical centres in Ireland, UK, Belgium, The Netherlands, Czech Republic, Malaysia, Australia and New Zealand.
Tal marked the occasion with a lunch with some of the medical professionals involved in the PEARS project as well as members of the support team.