Amplifi Vein Dilation System: 1st Human Use Successful Reports Artio Medical

UltraSight Raises $13 million to Bring AI Guidance for Cardiac Ultrasound to Patient Point of Care

The Yozma Group Korea, Atain Specialty Insurance Company and the Weizmann Institute of Science participated in the round.

Jon Hopkins New Senior Vice President-Chief Development Officer of Legion Healthcare Partners

Over the past 23 years, Jon has held various positions at Varian Medical Systems including Director of Sales, Americas West & Latin America, Varian Proton Solutions and prior Director of Worldwide Sales, Varian Particle Therapy.

Sinan Batman Appointed CTO of TeraRecon

Batman brings rich industry experience to TeraRecon, including Chief Engineer at Carestream/Kodak Health Group, where he defined the vision for image-centric workflow information systems.

January 27, 2021

Amplifi Vein Dilation System, successfully completed first human use has been reported by Artio Medical, Inc. The first clinical procedure was performed by Adrian Ebner, MD, the Head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asuncion, Paraguay.

An arteriovenous fistula (AVF) is the preferred type of vascular access for most end-stage renal disease patients requiring hemodialysis, and clinical research has shown that AVFs last longer and have fewer complications than other forms of access.1 Currently, about 35% of U.S. hemodialysis patients are ineligible to receive an AVF, predominantly due to small vein diameters.2 Of those patients who are eligible, more than 50% of AVFs fail to mature without additional procedures, and many of these sites are abandoned prior to routine use.2 Studies suggest baseline vein diameter may play an important role in eligibility for AVF surgery, and in achieving AVF maturation and use.3

“Vascular access is a constant challenge for end-stage renal disease patients who depend on hemodialysis treatment. Most patients are plagued with interrupted or delayed care due to repeated access site failures and require additional procedures and surgeries to maintain vascular access,” commented Dr. Ebner. “Many also frequently experience access site complications, often resulting in hospitalization and the need for additional care. I am pleased to be a part of the first human use for the Amplifi system. This is the first technology that seeks to address these challenges by proactively preparing patient’s veins for AVF creation.”

Artio Medical’s Amplifi Vein Dilation System is designed to stimulate arm vein enlargement in hemodialysis patients using rapid, non-pulsatile blood flow. The innovative system is designed for percutaneous placement and includes a wearable, external blood pump, inflow and outflow catheters, and a controller. The Amplifi system is used for 7 to 10 days and removed completely during AVF creation.

“I believe this device has the potential to change the standard of care for hemodialysis patients, allowing more patients to be eligible for AVF surgery and reducing the risk of AVF failure and abandonment,” continued Dr. Ebner. “The degree of vein dilation we observed during the treatment period for the first patient was remarkable, and the AVF made with the treated vein matured very rapidly.”

“Artio Medical is committed to developing novel devices that have the potential to provide better patient outcomes,” stated F. Nicholas Franano, MD, President and CEO of Artio Medical. “Many thanks to Dr. Ebner and the entire clinical team at Sanatorio Italiano for helping Artio reach this important milestone. We look forward to sharing the results of our first clinical experience with the Amplifi system.”

Artio Medical acquired the first-of-its-kind vein dilation technology through the acquisition of Flow Forward Medical, Inc. in June 2020. The Amplifi Vein Dilation System aims to address common issues related to vascular access site creation and maintenance for the 2.3 million patients worldwide with end-stage renal disease who require hemodialysis.2 Artio expects to complete the first-in-human clinical study in the first half of 2021.

spot_img

DON'T MISS

Subscribe to Medical Device News Magazine here.

Related Articles