Artio Medical Successfully Completes Enrollment of First-in-Human Trial Investigating the Amplifi™ Vein Dilation System
Novel vein dilation system aims to improve vascular access for hemodialysis patients
PRAIRIE VILLAGE, Kan., July 29, 2021 /PRNewswire/ -- Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, announced today it has completed enrollment in its first-in-human study evaluating the company's Amplifi™ Vein Dilation System. Five patients were treated by Dr. Adrian Ebner, the Head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asuncion, Paraguay. The Amplifi System is designed to stimulate arm vein enlargement in hemodialysis patients using rapid, non-pulsatile venous blood flow. After 7 days of treatment, the device is removed during surgery to create an arteriovenous fistula (AVF). The Amplifi System aims to make more hemodialysis patients eligible to receive an AVF, increase AVF maturation success, reduce maturation time, and prolong the usable life of AVFs.
"I am very pleased with my initial experience using the Amplifi System. The device was simple to implant and well tolerated by all patients," noted Dr. Ebner. "We observed significant vein enlargement in each enrolled patient and were able to successfully create AVFs in all patients after treatment, including patients who were poor candidates for AVF before treatment."
A reliable vascular access site is critical to delivering life-saving hemodialysis treatment, however these sites can be difficult to create and maintain, and complications and site failure remain a significant healthcare burden1. An AVF is the preferred type of vascular access for hemodialysis patients,2 yet only 63% of US hemodialysis patients use an AVF for vascular access. The National Kidney Foundation recommends forearm AVF as the first choice for vascular access, citing ease of creation, low complication rates, and preservation of more proximal access options3, however, only 32% of all AVF creations in the US are attempted in the forearm.4 In patients who are eligible for AVF, more than 50% fail to mature without additional procedures or surgeries, and many are abandoned prior to routine use.5 Studies suggest baseline vein diameter may play an important role in eligibility for AVF surgery, and in achieving AVF maturation and use.6 The Amplifi Vein Dilation System is the first and only medical device intended to dilate and prepare veins prior to AVF surgery.
"I am grateful for Dr. Ebner and the entire team at Sanatorio Italiano who contributed to the success of this first-in-human study," stated F. Nicholas Franano, MD, President and CEO of Artio Medical. "The company looks forward to sharing data on these first five patients in the coming months and building upon this promising early clinical experience. We remain focused on delivering a much-needed solution to the millions of patients worldwide who need hemodialysis."
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
Patients with end-stage renal disease have a complete loss of kidney function and usually require routine hemodialysis. 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. The AmplifiTM Vein Dilation System is a wearable, external blood pump system designed to stimulate arm vein enlargement in hemodialysis patients using rapid, non-pulsatile blood flow. The system is used for 7 days and removed during AVF surgery. The Amplifi System aims to make more patients eligible to receive an AVF and to increase successful maturation after AVF creation surgery.
1Mccarley P., et al. "Vascular access blood flow monitoring reduces access morbidity and costs". Kidney International. Vol. 60, Iss 3. Sept 2001, Pages 1164-1172.
2Hemodialysis National Institute of Diabetes and Digestive and Kidney Disease, https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis
3National Kidney Foundation KDOQI Guidelines. "Clinical Practice Guidelines and Clinical Practice Recommendations". 2006 Update. http://kidneyfoundation.cachefly.net/professionals/KDOQI/guideline_upHD_PD_VA/va_guide2.htm
4Pisoni RL., et al. "International Differences in the Location and Use of Arteriovenous Accesses Created for Hemodialysis: Results From the Dialysis Outcomes and Practice Patterns Study (DOPPS)". American Journal of Kidney Diseases. Vol 71, Iss 4, April 2018.
5United States Renal Data System (USRDS) End Stage Renal Disease Annual Data Report. 2018. https://www.usrds.org/
6Robbin M., et al. "Arteriovenous fistula development in the first 6 weeks after creation". Radiology. Vol. 279: No. 2 - May 2016
SOURCE Artio Medical, Inc.
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