Meridian - Development and validation of an innovative fenestrated endovascular stent graft for aortic aneurysm repair

Meridian - 用于主动脉瘤修复的创新型有窗血管内覆膜支架的开发和验证

• 批准号: 10038131
• 金额: $ 144.09万
• 依托单位: LOMBARD MEDICAL LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10038131
• 关键词: Meridian; Development; validation; innovative; fenestrated

Abdominal aortic aneurysm (AAA) causes ~6000 deaths/year in England and Wales, and \>175 000 deaths globally. These figures will likely increase due to our ageing population.AAAs occur in the aorta as it passes through the abdomen and may occur at any age but are most common as patients age, especially beyond 60 years of age. The condition is caused by weakening of the aortic wall and is associated with multiple risk factors including age, atherosclerosis, coronary heart disease, family history and genetics, plus lifestyle factors such as smoking.Historically, open surgery was used to repair AAA using artificial tubes sewn inside the aorta above and below the bulging section, a challenging procedure with many risks and mortality rates higher than open heart surgery.More recently, minimally invasive procedures involving endovascular grafting (EVAR) have been developed which significantly reduce the risks for patients. However, the individual anatomy of the patient's blood vessels can create technical challenges for EVAR as ~50% of patients with AAAs have anatomy that is not ideal for treatment using standard endovascular grafts.To overcome this, fenestrated endovascular grafts (FEVAR) have been developed for patients where the AAA gets close to key blood vessels. FEVAR devices have holes created in them to allow blood to flow to key organs close to the AAA. This is now a fairly common treatment for patients who may not otherwise be candidates for endovascular repair. FEVAR devices are relatively large and are often not compatible with safe treatment for women and some ethnic groups, thus disadvantaging them.Lombard will develop a new fenestrated graft product (Meridian) which provides a solution for challenging anatomies and enables FEVAR for patients with narrow blood vessels; it has the potential to significantly increase the diversity of patients that can be treated due to its much narrower size relative to any competitor device.Meridian is a ground-breaking medical innovation by:\*Increased applicability in those with severe vascular disease, females, and non-Caucasian groups.\*Reduced delivery diameter leads to lower vessel trauma and complication rates.\*Extending the use of the device to include the treatment of iliac aneurysms.\*Less limb ischaemia and easier insertion allows more procedures under local anaesthetic which reduces operative times and hospital stays.

腹主动脉瘤（AAA）在英格兰和威尔士每年造成约6000例死亡，在全球每年造成175000例死亡。这些数字可能会增加，由于我们的人口老龄化。AAA发生在主动脉，因为它通过腹部，并可能发生在任何年龄，但最常见的患者年龄，特别是超过60岁。这种情况是由主动脉壁弱化引起的，与多种风险因素有关，包括年龄、动脉粥样硬化、冠心病、家族史和遗传，以及吸烟等生活方式因素。历史上，开放手术用于修复AAA，使用人工管缝合在主动脉内隆起部分的上方和下方，最近，已经开发了涉及血管内移植（EVAR）的微创手术，其显著降低了患者的风险。然而，患者血管的个体解剖结构可能会给腹主动脉瘤腔内修复术带来技术挑战，因为约50%的AAA患者的解剖结构对于使用标准血管内移植物进行治疗并不理想。为了克服这一点，已经为AAA靠近关键血管的患者开发了开孔型血管内移植物（FEVAR）。FEVAR器械上有孔，允许血液流向靠近AAA的关键器官。这是目前对于不适合腔内修复术的患者的一种相当常见的治疗方法。FEVAR器械相对较大，通常与女性和某些种族群体的安全治疗不兼容，从而使其失去优势。（Meridian），为具有挑战性的解剖结构提供解决方案，并为血管狭窄的患者提供FEVAR;由于其尺寸相对于任何竞争对手器械要窄得多，因此有可能显著增加可治疗患者的多样性。突破性的医学创新：* 增加了对严重血管疾病患者、女性和非高加索人群的适用性。减小输送直径可降低血管创伤和并发症发生率。将该器械的使用范围扩展至髂动脉瘤的治疗。更少的肢体缺血和更容易的插入允许更多的程序下局部麻醉，减少手术时间和住院时间。