The FDA Breakthrough Device Designation helps patients with ESRD vein dilation indication to have enhanced access to FA-1 Device


The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Fist Assist Devices has secured the US Food and Drug Administration (FDA) breakthrough device designation (BDD) for its Fist Assist Model FA-1 device.

The Fist Assist Model FA-1 device is a wearable, intermittent pneumatic compression device, intended to promote vein dilation, when worn on the arm.

FA-1 device works by compressing the outflow vein, providing both biological and physiological benefits.

As the device is automated, it significantly improves patients’ compliance compared to other vein dilation alternatives, said the company.

Fist Assist regulatory advisor and CEO Hrishikesh Gadagkar said: “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.

“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.”

Fist Assist Devices is a medical device start-up focused on vein dilation for chronic kidney disease (CKD) patients, through End-Stage Renal Disease (ESRD).

According to the company, FA-1 is the world’s first wearable device for pre-surgical vein dilation that promotes AV fistula creation in chronic renal failure patients

With the FDA Breakthrough Device Designation, patients with an ESRD vein dilation indication are enabled to have enhanced access to FA-1 Device.

The device would help patients receive more timely access to advanced technologies for effective treatment of irreversible diseases, said the company.

Fist Assist Devices founder and CEO Tej Singh said: “This designation is another major milestone for Fist Assist Devices, LLC. We expect it to change the algorithm for patient care.

“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.”