Fist Assist’s FA-1 Device Receives FDA Breakthrough Device Designation for Presurgical Vein Dilation to Promote AVF Creation in ESRD Patients

December 16, 2021—Fist Assist Devices, LLC, a medical device company focused on vein dilation for patients with chronic kidney disease experiencing end-stage renal disease (ESRD), announced that it received Breakthrough Device designation from the FDA for the company’s FA-1 device.

According to the company, the FA-1 is a wearable, intermittent pneumatic compression device for presurgical vein dilation that promotes arteriovenous fistula (AVF) creation in adult patients diagnosed with chronic renal failure whose preoperative assessment of the venous anatomy suggests that superficial arm vein or perforator vein size is inadequate for the creation of an AVF for hemodialysis.

The device compresses the outflow vein, which has both biological and physiological benefits, and because it is automated, the FA-1 device improves patients’ compliance compared to other vein dilation alternatives, noted Fist Assist.

Fist Assist Devices advised that the FDA Breakthrough Device program will expedite access to the FA-1 device for patients with an ESRD vein dilation indication. The FDA program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions such as ESRD. The program provides priority FDA review and interactive communication regarding device development, clinical data, and future indication applications during the premarket review process.

Tej Singh, MD, Chief Executive Officer and Founder of Fist Assist Devices, commented in the company’s press release, “This designation is another major milestone for Fist Assist Devices, LLC. We expect it to change the algorithm for patient care.”

Dr. Singh continued, “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.”

On June 22, the company announced FDA clearance for the FA-1 device with an indication for arm massage and increased vein circulation. In that announcement the Fist Assist advised that the FA-1 device is marketed for increased forearm vein enhancement and arteriovenous fistula dilation/maturation in India, Canada, Europe, Australia, and New Zealand.