TELEGRAFT

Clinical need: 10% of the population worldwide is affected by chronic kidney disease (CKD) and millions die each year because they do not have access to treatment. Giving global shortage of kidney donors, the vast majority of patients rely on hemodialysis (HD). Over 2.6M people worldwide currently receive HD to stay alive, yet this number may only represent 10% of people needing treatment. Solution: Up to 70% of current arteriovenous grafts (AVG) fail in the first year after implantation. This is primarily due to thrombosis, luminal scar formation, and infection. In our ground-breaking new AVG, biomimicking zwitterions prevent thrombosis, drug delivery prevents scar formation and infection, and an ECM coating ensures fast tissue integration allowing early HD. Smart: TELEGRAFT comprises two diagnostic tools to monitor and prevent device complication. Pressure transmitters are used to monitor blood flow and optical sensors to detect inflammation and infections. The data is processed by AI machine learning models and displayed in an easy to understand dashboard for healthcare professionals. The data allows online telemonitoring and consultations by remote healthcare professionals. This makes home dialysis safe for patients, even in areas with poor infrastructure, where patients live far from HD clinics. Surgical implantation: The TELEGRAFT system will be demonstrated in an operational environment through a 2-stage randomized clinical trial enrolling 60 patients at 5 hospitals across Europe and through a home HD field study. Resource constrained setting: (1) In low and middle income countries, TELEGRAFT will substitute complicated and expensive kidney transplantation and allow simpler and cheap implantation of AVG for HD. (2) TELEGRAFT is the only solution with diagnostic tools allowing real-time online detection and remote monitoring of complications and device failure. This allows transition from HD at the hospital to the resource constrained home setting.