Principal Medical has developed the solution for the majority of AV access pathologies. Our novel, patented AV graft optimizes the flow through the graft to achieve optimal hemodynamics.
Narrowing the center of the graft prevents iatrogenic high flow (and resulting pathologies) outside of dialysis sessions. During dialysis sessions, the narrowing increases the inflow-outflow pressure differential through the dialyzer, potentially allowing for even higher flow while dialyzing.
Our graft has similar but superior geometry to precision banded grafts and fistulas. Precision banded accesses show patency rates of 90% at 2 years and lower intervention and thrombosis rates than typical accesses [1]. By putting a tapering in the center, our graft:
End Stage Renal Disease currently impacts 786,000 people in the US, with 130,000 new patients every year. Many of these patients need dialysis, and thus require AV access.
Hemodialysis requires high-flow, high volume access to the patient's blood, which is put through a dialyzer to filter the blood, usually for three hours per day, three times per week.
Current methods of achieving vascular access with high flow through the dialyzer have significant limitations and frequently result in the following pathologies:
Fistula and graft AV access create short circuits. All flow through the access is unused by the body, putting additional strain on the heart as it must keep up with both the demands of the body and the demands of the new vascular short circuit. On average, this requires an additional 1000ccs/min of cardiac output all day, every day, for months or years.
This loss of cardiac output is harmful for a population already burdened by cardiovascular pathologies.
This creates a conflict - patients need high flow through the dialyzer, but are harmed by the pathological hemodynamics of existing AV access methods.
[1] Miller, G.A., Goel, N., Friedman, A., Khariton, K., Arnold, W.P., Preddie, D.C., et al. (2009). The MILLER banding procedure is an effective method for treating dialysis-associated steal syndrome. Kidney International, 76(9), 962-967. https://doi.org/10.1038/ki.2009.461
[2] USRDS 2020 Report - https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/6-mortality