AMPLIFI-1 Trial Launched for Amplifi Vein Dilation System in Distal AVF Creation

May 27, 2026—Amplifi Vascular announced the initiation of the AMPLIFI-1 pivotal trial evaluating the safety and effectiveness of the Amplifi vein dilation system, an investigational technology designed to facilitate distal arteriovenous fistula (AVF) creation for hemodialysis access.

AMPLIFI-1 is expected to enroll patients across vascular surgery, interventional, and nephrology centers in North America.

According to the company, the first North American patients were treated at Brigham and Women’s Hospital in Boston, Massachusetts, by a multidisciplinary team led by Mohamad Hussain, MD, and Dirk Hentschel, MD.

Amplifi Vascular reported that the first cases were completed after just over 2 days of therapy in patients with cephalic veins below conventional thresholds for distal AVF creation. Both patients subsequently underwent successful surgical AVF creation, with immediate postprocedure ultrasound findings suggesting early physiologic AVF maturation as defined in the study protocol.

“Using the Amplifi system at Mass General Brigham, we were able to successfully create AVFs in patients who previously had no conventional AVF options after just over 2 days of treatment,” commented Dr. Hussain in the press release.

Dr. Hussain, Principal Investigator for AMPLIFI-1 at Brigham and Women’s Hospital, continued, “This first-in–North America experience not only highlights the potential of this technology but also underscores the importance of a highly coordinated multidisciplinary approach to safely deliver novel therapies for patients with advanced kidney disease.”

A primary objective of the study is to determine whether Amplifi therapy can enable functional AVF maturation within 2 weeks. This accelerated maturation timeline could reduce prolonged dependence on central venous catheters, which remain associated with infection, thrombosis, hospitalization, delayed care, and increased costs in patients undergoing hemodialysis, noted the company.

The company stated that the Amplifi system is designed to remodel the target vein before surgery through controlled, directional, continuous flow-mediated dilation therapy delivered to the cephalic vein over a short treatment interval.