Fist Assist Devices announced today that it received FDA breakthrough device designation for the Fist Assist model FA-1 device.
Las Vegas-based Fist Assist touts its FA-1 device as the world’s first wearable for pre-surgical vein dilation that promotes AV fistula creation in adult patients diagnosed with chronic renal failure whose pre-operative assessment of the venous anatomy suggests that superficial arm vein or perforator vein size is inadequate for the creation of an AV fistula for hemodialysis.
According to a news release, the company designed the Fist Assist model FA-1 to be an intermittent pneumatic compression device worn on the arm to promote vein dilation. The automated device compresses the outflow vein and, according to Fist Assist, significantly improves patient compliance compared to other vein dilation alternatives.
Fist Assist Founder & CEO Dr. Tej Singh said in the release that recently published data from the FACT trial on stage 4 vein dilation and the pFACT trial on perforator vein dilation confirmed the value of the company’s intermittent vein compression.
“The FA-1 device benefits patients, physicians, and health care delivery systems because larger veins give patients more treatment options regarding surgical or endoAVF procedures,” Singh said. “Ultimately our goals are to help patients achieve better outcomes and have more hope. This breakthrough designation gets us one step closer to accomplishing our goals.”