Improving outcomes for haemodialysis patients through minimally invasive arteriovenous fistula creation

全球范围内最重要、代价最高且不断增长的健康流行病之一是4.22亿人患有糖尿病。糖尿病是肾衰竭的主要原因，肾衰竭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外部过滤 **。目前为患者准备透析的“黄金标准”涉及开放式外科手术以创建血管通路部位（AVF），其中血管被切开并缝合在一起以形成“短路”，从而增加这些血管中的血流，允许透析机“进入”患者的血液供应并有效过滤。** AVF是患者的“生命线”和消极的结果（25%立即失败; 1年后50%，需要6个月才能愈合）对生命构成严重威胁 **，需要昂贵的重复手术（\>3/年）.为应对这一挑战，PFM将在技术上推进其新型导管系统，以 ** 使用支架/支架移植物实现分离和较小血管之间更复杂的连接 **，允许临床医生以最小侵入的方式安全可靠地创建血管进入部位。该专利核心技术已获得CE认证，并在可行性研究和临床环境中得到验证，用于动脉旁路阻塞，仅在同一血管的两个管腔之间创建一个孔。这一最初的应用已经成为“临床踏脚石”（风险最低），以证明这一概念在解决更迫切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的可寻址市场并加速商业化，使他们能够为更多患者提供微创手术替代方案，提高生活质量，并显着降低医疗保健系统的成本。仅在英国，采用微创方法创建AVF，失败率较低，并使透析能够更早开始，每年可以为NHS节省7900万英镑。

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.**