Amplifi Vascular, an innovative company focused on transforming vascular access for hemodialysis patients, has developed the first-of-its-kind Vein Dilation System. This technology is designed to increase patient eligibility and enhance both the creation and early maturation of arteriovenous fistulas (AVFs).
The company recently announced three major milestones that underscore its progress and commitment to improving patient outcomes: the positive results from its first-in-human (FIH) study, the successful completion of a $6.9 million Series A financing round, and the receipt of approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE).
The Amplifi FIH Study involved a total of 19 patients who were selected to participate in a procedure aimed at pre-dilating the veins before surgical creation of the AVF. The study successfully met its primary objectives, showing rapid enlargement of the veins following the procedure. This enlargement is crucial as it supports the successful creation of the fistula, facilitates physiological maturation—characterized by veins reaching a diameter of at least 5 mm and a blood flow rate of 500 ml/min or more—and allows for early functional use of the AVF.
Throughout the study, there were no significant adverse events related to the device reported, which adds to the safety profile of the Vein Dilation System. These promising results highlight the system’s potential to tackle the underlying issues associated with prolonged maturation times and the historically high failure rates of AVFs. By improving these aspects, the technology could significantly boost the success rates of forearm AVFs and potentially minimize the reliance on alternative access methods, such as dialysis catheters and vascular grafts.
With the FDA’s approval of the IDE, Amplifi is poised to launch the AMPLIFI-1 clinical trial in the United States. This investigation will further assess the safety and performance of the Vein Dilation System, comparing its effectiveness and time to functional maturation against standard care practices. The outcome of this study could have substantial implications for the future of vascular access in hemodialysis, paving the way for enhanced treatment options for patients and improved overall kidney care.
KEY QUOTES:
“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. Furthermore, the FDA IDE approval empowers us to commence a U.S. clinical investigation, directly addressing the underlying causes of extended maturation times and elevated failure rates in AVF creation.”
Sean Morris, President and Chief Executive, Amplifi Vascular
“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.”
Surendra Shenoy, MD, Washington University, St. Louis School of Medicine
