Improving outcomes for haemodialysis patients through minimally invasive arteriovenous fistula creation

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.**