96242Novel arteriovenous (AV) fistula device to treat hypertension in drug resistant patientsClosedCollaborative R&DInnovate UKHigh 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.