PRAIRIE VILLAGE, Kan., Nov. 30, 2021 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, today announced that full results from its first-in-human (FIH) clinical study of the Amplifi™ Vein Dilation System were presented at the 2021 VEITH Symposium by Surendra Shenoy, MD-PhD, an Associate Professor of Surgery at the Washington University School of Medicine at Barnes-Jewish Hospital in St. Louis, Missouri.
“Data from the first five patients treated with the Amplifi System demonstrated more than a doubling of forearm and upper arm cephalic vein diameters following a mean treatment period of 8.6 days. We were able to successfully create an arteriovenous fistula (AVF) using treated veins in all patients and observed rapid and robust AVF maturation,” commented Dr. Shenoy. “This data is very encouraging and I believe this technology has the potential to offer a much-needed solution for increasing AVF suitability and reducing maturation failure.”
Quickly establishing a reliable, long-lasting vascular access site is critical for end-stage renal disease patients who require lifesaving hemodialysis treatment. Although an AVF is the preferred form of vascular access, many hemodialysis patients are not suitable for an AVF, often due to small vein diameters. For those patients who are suitable, AVF maturation failure rates are high and prior studies have shown a correlation between small vein diameter and fistula failure.¹ The Amplifi Vein Dilation System is designed to stimulate arm vein enlargement prior to AVF creation to make more patients eligible for AVF surgery, reduce the time required for AVF maturation, and increase successful maturation rates.
Dr. Shenoy added, “When physicians create AVFs today, we know there are often vein segments with pre-existing problems, but we don’t currently have adequate tools to identify these segments, which contributes to the high rate of AVF maturation failure. The Amplifi System could allow physicians to better identify these segments and either treat them at the time of AVF creation or exclude them from the AVF circuit. In this study, three of the five patients had pre-existing problems in the cephalic vein which were made more apparent by Amplifi System treatment. In one patient an AVF was made more proximally and in another angioplasty was performed, and both patients went on to have successful AVF maturation and use.”
“We are pleased to have the data from the Amplifi System FIH presented at the VEITH conference and look forward to building upon this initial clinical experience with our US IDE trial which is projected to begin enrollment in 2023,” said Erdie De Peralta, Vice President of Clinical and Regulatory Affairs at Artio Medical.
About Artio Medical
Artio Medical is a medical device company committed to developing innovative products for the treatment of peripheral vascular, neurovascular, and structural heart diseases. For more information, please visit www.artiomedical.com.
About the Amplifi ™ Vein Dilation System
An estimated 2.3 million end-stage renal disease patients require life-sustaining hemodialysis treatment worldwide. Creating and maintaining a suitable vascular access site is one of the most difficult and expensive aspects of hemodialysis. The National Kidney Foundation and Centers for Medicare and Medicaid Services agree that an arteriovenous fistula (AVF) is the preferred form of vascular access, however an estimated 35% of U.S. patients are ineligible for AVF surgery and more than 50% of AVFs fail to mature.²·³ The Amplifi Vein Dilation System is a wearable, external blood pump system designed to stimulate arm vein enlargement in hemodialysis patients prior to AVF creation through a treatment of the arm with rapid, non-pulsatile blood flow for up to 14 days. The Amplifi System aims to make more patients eligible for AVF surgery, reduce the time required for AVF maturation, and increase successful maturation after AVF creation.
1. Robbin, et al. “Arteriovenous Fistula Development in the First 6 Weeks After Creation”, Radiology. Volume 279, May 2016
2. Hemodialysis National Institute of Diabetes and Digestive and Kidney Disease, https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis
3. United States Renal Data System (USRDS) End Stage Renal Disease Annual Report 2018, https://www.usrds.org/
SOURCE Artio Medical, Inc.
