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

全世界大约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%。高血压使人们患中风、心脏病、心力衰竭、肾衰竭和其他严重疾病的风险大大增加。它可能在全世界13%的死亡中起作用。降低血压可以通过改变生活方式和某些药物来实现。然而，只有60%的患者达到了可以接受的降压效果，而且从长远来看，只有20%的患者得到了很好的控制。10%到30%的患者对药物产生抗药性，大约50%的患者在指定的时候不服用药片，这降低了疗效。对于医疗保健提供者来说，高血压的管理既耗时又昂贵--它占美国医疗保健支出的486亿美元，在英国高达21亿GB。Aven Medical正在开发一种植入式医疗设备(The Avenue)，可用于在其他治疗方法无效的高血压患者中降低血压。该设备就像一个中心有一个孔的小铆钉，由医学专家在医院的一个短程序中放置。植入物创造了一个永久性的开口，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。该装置处于早期开发阶段，工作原型已经生产出来，实验室研究证明它在技术上是可行的。该项目的主要重点是完成人体身体研究以确认植入的安全性，完成体内研究以确定流动特性并改进设计，并为该装置的首次人体试验做准备。如果成功，市场是巨大的，我们估计每年总机会在30亿GB左右。Avenue设备的设计基于一种著名的产品，该产品已在60,000多个医疗程序中使用，并被批准在欧洲和美国使用。因此，我们可以确定所使用的材料(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条永久通道，允许降低血压。

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.