Amplifi Vascular recently announced the successful initiation of the AMPLIFI-1 trial at Brigham and Women’s Hospital in Boston, USA. The first North American patients were treated by a multidisciplinary clinical team led by Mohamad Hussain and Dirk Hentschel.
The AMPLIFI-1 trial is designed to evaluate the safety and effectiveness of the Amplifi vein dilation system in patients requiring distal arteriovenous fistula (AVF) creation for haemodialysis access. A central objective of the study is to determine whether Amplifi therapy can enable functional AVF maturation at two weeks. Amplifi Vascular describes this as a “clinically meaningful acceleration” compared with the traditional AVF maturation pathway, which can often take several weeks to months and may require prolonged catheter dependence.
The first cases were completed at Brigham and Women’s Hospital following just over two days of Amplifi therapy. Amplifi Vascular reports that both patients began with cephalic veins below conventional thresholds for distal AVF creation and subsequently underwent successful surgical AVF creation, with immediate post-creation ultrasound findings indicating early physiologic AVF maturation, as defined in the protocol.
“Using the Amplifi system at Mass General Brigham, we were able to successfully create arteriovenous fistulas in patients who previously had no conventional AVF options after just over two days of treatment,” said Hussain, principal investigator for AMPLIFI-1. “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. We are excited about this innovation and look forward to the results of the AMPLIFI-1 trial.”
AMPLIFI-1 is expected to enrol patients across leading vascular surgery, interventional, and nephrology centres in North America.
Amplifi Vascular advises that the Amplifi system is an investigational device and is not approved or cleared by the US Food and Drug Administration (FDA), specifying that safety and effectiveness have not yet been established.
