Amplifi Vein Dilation System
Vascular access medical device
A wearable external blood pump system, comprising inflow and outflow catheters and a rechargeable battery-powered controller, that increases flow through a target forearm vein to rapidly enlarge it in the days before arteriovenous fistula creation surgery.
- Wearable external blood pump with inflow and outflow catheters
- Rechargeable battery-powered controller
- Rapid pre-surgical vein enlargement over a period of days
- FDA Breakthrough Device designation
- FDA Investigational Device Exemption approval for the AMPLIFI-1 pivotal trial
- First-in-human study in 19 patients with no significant device-related adverse events
Built for
Vascular access surgeons, nephrologists and dialysis centers treating end-stage kidney disease patients who require arteriovenous fistula creation for hemodialysis