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

主动脉是人体内最大的动脉，从心脏向下通向腹部。动脉粥样硬化（一种常见的情况，动脉被斑块堵塞，导致它们变硬和变窄）会削弱和变薄血管壁，可能发生动脉瘤，动脉瘤可能破裂，导致大量内出血，如果不及时治疗会迅速死亡。腹/胸主动脉瘤（AAA/TAA）修复术的标准治疗方法是开放性手术，然而，动脉瘤腔内修复术（EVAR）手术-通过导管通过腹股沟小切口插入血管内覆膜支架的微创方法-已变得越来越受欢迎，其受益包括降低风险（特别是对于老年/不健康的患者），住院时间更短，恢复更快，并发症减少，死亡率更低。虽然血管内覆膜支架置入术彻底改变了AAA/TAA的治疗，但并非没有并发症。覆膜支架的有效功能取决于支架和血管壁之间的紧密配合;然而，动脉粥样硬化患者极有可能存在钙化斑块沉积和其他血管壁异常，这可能会损害插入支架的有效配合。约40%的患者在覆膜支架外部周围发生血液泄漏（内漏），这可能导致动脉瘤再充盈并继续生长。I型内漏（最严重）的修复需要额外的手术和治疗，这是昂贵的，增加了并发症，风险和死亡率。目前的方法集中于一旦出现内漏的“修复”。很明显，对于一种能够主动“预防”血管内支架植入物放置中昂贵且危及生命的内漏问题的装置存在未满足的需求。Newtec Vascular Products已经为一种新型血管外科装置“StentSeal”申请了专利，该装置旨在通过在支架植入物和血管壁之间形成完美的密封来防止内漏，并改善AAA和TAA修复的结局（可转移至其他血管）。影响包括显著节省成本、改善患者结局、减少并发症/死亡率和提高腹主动脉瘤腔内修复术的成本效益。本项目的重点是通过详细的市场研究和材料调查、器械设计和概念开发（将概念推进到TRL 3）来证明该方法的可行性。项目产出将为下一阶段的研发（原型设计，临床前测试，首次人体临床试验）提供信息，然后在全球主动脉覆膜支架市场商业化，预计到2028年将达到45亿美元。该项目将为Newtec带来显著的出口导向型增长，可观的投资回报率，增加就业机会和进一步的研发投资机会。

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.