Amplifi Vascular has announced positive first-in-human (FIH) study results for its vein dilation system, designed to increase eligibility, improve creation and early maturation of arteriovenous fistulas (AVFs) for haemodialysis.
The milestone comes alongside the closing of a US$6.9 million series A financing, and US Food and Drug Administration (FDA) approval of its investigational device exemption (IDE).
The Amplifi FIH study enrolled 19 patients to pre-dilate veins prior to surgical AVF creation. The study met its primary objectives, with rapid post-procedure vein enlargement supporting successful fistula creation, physiological maturation (≥5mm in diameter and ≥500ml/min flow), and early functional use.
No significant device-related adverse events were reported. Results support the system’s potential to address the root cause of extended time to maturation and historical high degree of failure leading to an increase in rates of forearm AVF success and to potentially reduce the dependence on dialysis catheters and grafts.
“Our first-in-human study not only met its primary objectives but also demonstrated rapid post-procedure vein enlargement, facilitating successful fistula creation, physiological maturation, and early functional use,” stated Sean Morris, president and chief executive of Amplifi Vascular. “Furthermore, the FDA IDE approval empowers us to commence a US clinical investigation, directly addressing the underlying causes of extended maturation times and elevated failure rates in AVF creation.”
FDA IDE approval enables Amplifi to initiate AMPLIFI-1, a US clinical investigation evaluating safety, performance, and time to functional maturation compared with standard care.
Surendra Shenoy (Washington University, St Louis School of Medicine, St Louis, USA) said: “Early outcomes suggest that proactive vein dilation prior to AVF surgery can significantly improve the likelihood of achieving a usable fistula sooner—an outcome that matters greatly to our dialysis patients.”
