‘StentSeal’ – an innovative vascular surgery device to prevent ‘endoleaks’ in endovascular stent-graft placement

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The aorta is the largest artery in the body, leading from the heart down to the abdomen. Atherosclerosis (a common condition where arteries become clogged with plaques, causing them to harden and narrow) weakens and thins the vessel walls and aneurysms can occur, which can rupture, causing massive internal bleeding and rapid death if left untreated. The standard treatment method for an Abdominal/Thoracic Aortic Aneurysm (AAA/TAA) repair is open surgery, however endovascular aneurysm repair (EVAR) procedures - minimally invasive methods where an endovascular stent graft is inserted via a catheter through a small incision in the groin - have become increasingly popular with benefits including reduced risks (especially for older/unfit patients), shorter hospital stays, quicker recovery, reduced complications and lower mortality rates. Whilst endovascular stent-graft placement has revolutionized the treatment of AAA/TAA, it is not without complications. The effective functioning of the stent-graft depends upon a very close fit between the stent and the vessel wall; however, patients with atherosclerosis are highly likely to have calcified plaque deposits and other vessel wall abnormalities which can compromise the effective fit of the inserted stent. ~40% of patients experience blood leakage (endoleaks) around the outside of the stent-graft, which can result in the aneurysm refilling and continuing to grow. Repair of Type I endoleaks (most critical) requires additional surgery and treatment which is expensive, increases complications, risks and mortality. Current approaches focus on the 'repair' of endoleaks once presented. There is a clear unmet need for a device that can actively 'prevent' the costly and life-threatening problem of endoleaks in endovascular stent-graft placement.Newtec Vascular Products has patented a novel vascular surgery device 'StentSeal', designed to **prevent** endoleaks through creating a perfect seal between the stent graft and the vessel wall, and improve outcomes in both AAA and TAA repair (with transferability to other vessels). Impacts include significant cost savings, improved patient outcomes, reduced complications/mortality and improved cost-effectiveness of EVAR.The focus of this project is to prove the feasibility of the approach through detailed market research and materials investigation, device design and concept development (progressing the concept to TRL3). Project outputs will inform next stages of R&D (prototyping, pre-clinical testing, first-in-man clinical trial), prior to commercialisation in the global Aortic Stent Graft market, estimated to reach $4.5billion by 2028\. The project will deliver significant export led growth for Newtec, a substantial ROI, increased employment and further opportunity for R&D investment.