Novel arteriovenous (AV) fistula device to treat hypertension in drug resistant patients

新型动静脉（AV）瘘装置治疗耐药患者高血压

• 批准号: 96242
• 金额: $ 39.63万
• 依托单位: AVEN MEDICAL UK LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=96242
• 关键词: Novel; arteriovenous; AV; fistula; device

High blood pressure affects approximately a quarter of adults worldwide. The overall incidence is on the rise and is expected to increase by 60% by 2025\. Having high blood pressure puts people at greatly increased risk of stroke, heart attacks, heart failure, kidney failure and other serious medical conditions. It may play a role in 13% of all deaths worldwide.The reduction of blood pressure may be achieved by life-style modification and certain drugs. However, only 60% of patients achieve acceptable blood pressure lowering and in the long-term only 20% are well controlled. Between 10 and 30% of patients are resistant to drugs, and around 50% do not take their tablets when specified which reduces the effectiveness. The management of high blood pressure is time-consuming and expensive for healthcare providers-- it accounts for $48.6 billion of healthcare spend in the USA and up to £2.1 billion in the UK.Aven Medical is developing an implantable medical device (the AveNue) that may be used to reduce blood pressure in patients with high blood pressure where other treatments have failed. The device is like a small rivet with a central hole that is placed by a medical specialist during a short procedure in a hospital. The implant creates a permanent opening that allows blood to flow from the high pressure arterial circulatory system into the low pressure venous system thereby reducing the patient's blood pressure.The device is in the early stages of development, working prototypes have been produced and laboratory studies have proven it to be technically feasible. The primary focus of this project is to complete human cadaver studies to confirm safe implantation, to complete in-vivo studies to determine flow characteristics and refine the design and to prepare for first-in-human studies of the device.If successful, the market is massive, we estimate the total opportunity to be in the region of £3 billion per annum. The AveNue device design is based upon a well-known product that has been used in over 60,000 medical procedures and is approved for use in Europe and in the USA. Because of this, we can be certain that the material used (medical grade stainless steel) is suitable. The innovative design feature is the establishment of a permanent passageway between an artery and a vein that allows the reduction of blood pressure.

全世界大约有四分之一的成年人患有高血压。总体发病率呈上升趋势，预计到2025年将增加60%。患有高血压的人患中风、心脏病、心力衰竭、肾衰竭和其他严重疾病的风险大大增加。它可能在全球13%的死亡中起作用。血压的降低可以通过改变生活方式和某些药物来实现。然而，只有60%的患者达到了可接受的血压降低，长期来看，只有20%的患者得到了良好的控制。10%至30%的患者对药物有耐药性，约50%的患者在指定时不服用药片，从而降低了疗效。对于医疗保健提供者来说，高血压的管理既耗时又昂贵——在美国，高血压占医疗保健支出的486亿美元，在英国则高达21亿英镑。Aven Medical正在开发一种植入式医疗设备（AveNue），可用于降低其他治疗无效的高血压患者的血压。该装置就像一个有中心孔的小铆钉，由医疗专家在医院的一个简短程序中放置。植入物创造了一个永久的开口，允许血液从高压动脉循环系统流入低压静脉系统，从而降低患者的血压。该设备处于开发的早期阶段，工作原型已经生产出来，实验室研究已经证明它在技术上是可行的。该项目的主要重点是完成人体尸体研究以确认安全植入，完成体内研究以确定流动特性并完善设计，并为该设备的首次人体研究做准备。如果成功，市场是巨大的，我们估计每年的总机会在30亿英镑左右。AveNue设备的设计基于一种知名产品，该产品已在60,000多个医疗程序中使用，并在欧洲和美国获得批准使用。正因为如此，我们可以肯定使用的材料（医用级不锈钢）是合适的。创新的设计特点是在动脉和静脉之间建立了一个永久性的通道，可以降低血压。