Artio Medical’s Amplifi Vein Dilation System Evaluated in FIH Study

November 2, 2022—Surendra Shenoy, MD, presented results from the first-in-human (FIH) study of the Amplifi vein dilation system (Artio Medical, Inc.), which is composed of a wearable pump and catheters that help dilate veins before creation of a forearm arteriovenous fistula (AVF) in patients with end-stage renal disease (ESRD).

The findings were presented by Dr. Shenoy in a Late-Breaking Clinical Trials session at The VEINS conference, hosted by the VIVA Foundation and held October 30-31, 2022, in Las Vegas, Nevada.

According to the VIVA Foundation press release, the Amplifi system is designed to deliver nonpulsatile, supraphysiologic wall shear stresses within the target vein to stimulate flow-mediated dilation. The treatment yields dilated veins that have a higher probability of maturation with subsequent AVF creation.

The press release noted that a forearm AVF that has fewer complications and preserves proximal sites for future access is the best initial access option for dialysis patients with ESRD. However, maturation failure of forearm AVF is as high as 85% and only 32% of AVFs are attempted in the forearm. Small vein diameter strongly correlates with maturation failure; 6-mm veins have a 75% probability of maturation versus 10% for 3-mm veins.

As summarized by the VIVA Foundation, the first cohort of five ESRD patients in this prospective, nonrandomized, single-arm, open-label, FIH clinical study were treated between Q1 and Q3 2021 at Sanatorio Italiano in Asunción, Paraguay. A second cohort was treated in Q3 2022.

Mean treatment duration was 8.6 days in cohort 1 and 6.3 days in cohort 2. All AVFs in cohort 2 were created in the forearm. After treatment, an AVF was created with a treated vein, and ultrasound examination was performed at day 1, week 2, and week 6. There were no serious device or procedural adverse events.

Treatment with the Amplifi system resulted in a 151% increase in cephalic vein diameter, with a 134% concomitant increase in flow rate. AVFs made with treated veins were fully mature within 2 weeks, and all patients were cleared for hemodialysis using their AVFs by week 6.

The Amplifi system is in development and not available for commercial use, advised the VIVA Foundation press release.