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

腹主动脉瘤(AAA)每年在英格兰和威尔士造成约6000人死亡，在全球范围内造成17.5万人死亡。这些数字可能会随着人口老龄化而增加。AAA发生在穿过腹部的大动脉中，可能发生在任何年龄，但最常见的是随着患者年龄的增长，特别是60岁以上的患者。这种情况是由主动脉壁变弱引起的，与多种危险因素有关，包括年龄、动脉粥样硬化、冠心病、家族史和遗传因素，以及吸烟等生活方式因素。从历史上看，开放手术是通过缝合主动脉内隆起部分上下的人工管来修复AAA，这是一种具有挑战性的手术，风险和死亡率高于开胸手术。最近，涉及腔内移植(EVAR)的微创手术已经开发出来，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EVAR带来技术挑战，因为约50%的AAA患者的解剖结构不适合使用标准血管内移植治疗。为了克服这一问题，为AAA接近关键血管的患者开发了开窗血管内移植(FEVAR)。FEVAR设备上有洞，允许血液流向AAA附近的关键器官。对于那些可能不适合血管内修复的患者来说，这是一种相当常见的治疗方法。FEVAR设备相对较大，通常与女性和一些民族的安全治疗不兼容，因此对她们不利。Lombard将开发一种新的带窗移植产品(Meridian)，该产品为具有挑战性的解剖提供解决方案，并使FEVAR能够用于狭窄血管的患者；与任何竞争对手的设备相比，它的尺寸要窄得多，因此它有可能显著增加可治疗的患者的多样性。Meridian是一项开创性的医学创新，它通过以下方式提高了对严重血管疾病、女性和非高加索人群的适用性。\*减少输送直径可以降低血管损伤和并发症发生率。\*将该设备的使用扩大到包括治疗髂动脉瘤。\*肢体缺血更少，插入更容易，从而允许在局部麻醉下进行更多的手术，从而减少手术时间和住院时间。

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.