Tele: 561.316.3330

Breaking Medical Device Industry News

Friday, October 22, 2021



Artio Medical’s Amplifi™ Vein Dilation System Highlighted at 2021 VIVA Conference

First-of-its-kind technology demonstrates exceptional initial results in hemodialysis patients

Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, today announced that preliminary clinical results from its first-in-human study of the Amplifi Vein Dilation System were presented at the 2021 Vascular Interventional Advances (VIVA) conference. Data were presented during a Late-Breaking Clinical Trial session 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.

A reliable, long-lasting vascular access site is critical for end-stage renal disease patients who require lifesaving hemodialysis treatment. Although an arteriovenous fistula (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 failure.1

Data presented from the first five patients treated in a prospective, non-randomized, single-arm first-in-human clinical study with Artio Medical’s Amplifi Vein Dilation System demonstrated more than a doubling of forearm and upper arm mean cephalic vein diameters with a mean treatment period of 8.6 days. AVFs were successfully created using treated veins in all patients. Maturation data is available for the first three patients showing that both the forearm and upper arm AVFs matured quickly with mean outflow vein diameter of 7 mm and a mean blood flow rate more than 1,000 mL/min after a 6-week maturation period. No device or procedural adverse events were observed.

The Amplifi System is designed for percutaneous placement and up to 14 days of use to stimulate arm vein enlargement in hemodialysis patients using rapid, non-pulsatile, venous blood flow. The device includes a wearable external blood pump, inflow and outflow catheters, and a controller all of which are removed completely during AVF creation. The company is planning for a potential US clinical trial in 2022.

“I was excited to have the privilege to present these results from Artio’s first-in-human study with the Amplifi System at the 2021 VIVA Conference Late-Breaking Clinical Trial session,” commented Surendra Shenoy, MD-PhD. “Not long after AVFs were first pioneered for hemodialysis in 1966 by doctors Cimino, Brescia, and Appel, concerns were raised about patients who were not suitable for AVF surgery and the high rate of AVF maturation failure. Despite these challenges, AVF remains the preferred option for most patients today. The Amplifi System is the first device I have seen that has real potential to address both of these challenges in a major way, to make good on the promise of providing reliable, long-lasting vascular access sites for this unique and vulnerable patient population.”

First human use in January 2021.

Other Articles

Zerigo Health Raises $43 Million in Series B Funding

This round will allow Zerigo Health to respond to the increasing demand for its innovative connected chronic skin condition solution for the over 40 million Americans living with psoriasis, vitiligo, and eczema.

DentalMonitoring, the Leading AI-Based Dental Software Company, Announces a $150 Million Growth Financing, Reaching a Valuation Over $1 Billion

The round is led by a new investment of $90 million from Mérieux Equity Partners and $60 million from Vitruvian Partners, an existing financial investor, demonstrating confidence in the company’s ambitious plans.

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Endolumik Inc. of Morgantown Secures $175,000 Angel Investment from Country Roads Angel Network

Endolumik, Inc. was founded in May 2020 by Mara McFadden, chief executive officer, and Dr. Nova Szoka, inventor of the surgical device.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

By using this website you agree to accept Medical Device News Magazine Privacy Policy