Fist Assist’s Wearable Vein Dilation Device Earns Breakthrough Status

Fist Assist Devices, a company specializing in vein dilation for chronic kidney disease, has gained FDA breakthrough status for its Fist Assist Model FA-1 device.
 
According to the company, FA-1 is the world’s first wearable device to promote AV fistula creation via pre-surgical vein dilation for chronic renal failure patients whose pre-op venous anatomy suggests superficial arm or perforator vein size is inadequate to create an AV fistula for hemodialysis.
 
“As this is a first-of-its-kind wearable device for hemodialysis patients focused on pre-surgery vein dilation, we are ecstatic to have the FDA recognize this innovative approach to vein dilation and the potential of this therapeutic wearable device that supports the patient’s journey through ESRD,” Hrishikesh Gadagkar, Ph.D., Fist Assist regulatory advisor and CEO, Idonea Solutions told the press. “We appreciate the FDA’s thorough review of Fist Assist’s Breakthrough Device designation request and look forward to a collaborative relationship as the company develops its FDA de novo classification application.”
 
The wearable, intermittent pneumatic compression device is worn on the arm to spur vein dilation. It compresses the outflow vein for both biological and physiological benefits. The FA-1 device is automated to improve patient compliance as well.
 
“This designation is another major milestone for Fist Assist Devices, LLC. We expect it to change the algorithm for patient care,” said Dr. Tej Singh, Founder and CEO of Fist Assist Devices, LLC. “The recently published data from the FACT trial on stage 4 vein dilation and pFACT trial on perforator vein dilation confirms the value of intermittent vein compression to CKD patients. 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. 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.”