Fist Assist Devices’ vein dilator for patients with end-stage renal disease (ESRD) has been designated a breakthrough device by the FDA.

The Model FA-1 device is a pneumatic compression device worn on the arm to promote vein dilation in patients with chronic renal failure whose vein size is inadequate for the creation of an arteriovenous (AV) fistula for hemodialysis. The FA-1 dilates the patient’s veins before surgery to promote AV fistula creation.

The automated compression device significantly improves patients’ compliance compared to other vein dilation methods, the company said.