Improving outcomes for haemodialysis patients through minimally invasive arteriovenous fistula creation

4.22亿糖尿病患者是世界范围内最严重、代价最高且不断增长的卫生流行病之一。糖尿病是肾衰竭的主要原因，这是一种负担沉重的慢性疾病，导致**340万患者需要通过血液透析进行常规的体外血液过滤**。目前为患者准备透析的“黄金标准”包括一种开放的外科手术程序，以创建一个血管通路部位(AVF)，在那里血管被解剖并缝合在一起，形成一个“短路”，增加这些血管中的血流量，使透析机能够“接入”病人的血液供应并有效地过滤它。**动静脉瘘是患者的“生命线”，在创建过程中会产生负面后果(25%立即失败；50%在一年后失败，需要6个月才能痊愈)，构成严重的生命危险**并需要昂贵的重复手术(\&gt；3/年)。为了应对这一挑战，PFM将从技术上改进其新型导管系统，**使用支架/支架移植物**实现分离血管和较小血管之间更复杂的连接**，使临床医生能够以最小创伤的方式安全可靠地创建血管通路。这项获得专利的核心技术已获得CE标志，并在可行性研究和临床环境中得到验证，可以绕过动脉中的堵塞，在同一血管中只在两个管腔之间形成一个洞。这一最初的应用已成为“临床垫脚石”(最低风险)，以证明这一概念在解决更紧迫的临床需求的道路上：**创建安全可靠的AVF**。项目的成功将增加PFM的潜在市场并加快商业化进程，使他们能够为更多的患者提供一种微创的手术替代方案，提高生活质量，并显著降低医疗保健系统的成本。仅在英国，采用微创方法**减少AVF的失败次数，并使透析更早开始，可以为NHS节省7900万GB/年。**

One of the most significant, costly, and growing world-wide health epidemics is the 422million people suffering from diabetes. Diabetes is the leading cause of kidney failure, a burdensome chronic condition, resulting in **3.4million patients requiring their blood to be routinely filtered externally through haemodialysis**. The current 'gold-standard' for preparing patients for dialysis involves an open surgical procedure to create a vascular access site (AVF), where blood vessels are dissected and sutured together to form a "short-circuit" which increases blood flow in these vessels, allowing for a dialysis machine to "access" the patient's blood supply and efficiently filter it. **The AVF is a patient's "life-line" and negative outcomes during creation (25% fail immediately; 50% after 1-year, and take 6-months to heal) presents a serious danger to life** and necessitates costly repeat procedures (\>3/year).To address the challenge, PFM will technically advance its novel catheter system to **enable more complex connections between separate and smaller vessels** using a stent/stent-graft, allowing clinicians to create a vascular access site safely and reliably in a minimally invasive manner. The patented core technology has been CE marked, proven in feasibility studies and in a clinical environment for bypassing blockages in arteries, where only a hole between two lumens in the same vessel is created. This initial application has served as a "clinical stepping-stone" (lowest-risk), to prove the concept on the path toward addressing a more dire clinical need: **the creation of a safe and reliable AVF**. Project success will increase PFM's addressable market and accelerate commercialisation, allowing them to provide a minimally invasive alternative to surgery for more patients, improving quality-of-life, and significantly reducing costs for the healthcare system. In the UK alone, adopting a minimally invasive approach to **AVF creation that fails less often and enables dialysis to start earlier could save the NHS £79million/year.**