Fist Assist's FA-1 Device Shown to Significantly Dilate the Perforator Vein in p-FACT Cohort Data

August 18, 2021—Fist Assist Devices, LLC, announced data from the p-FACT cohort, a subset of the recently completed Fist Assist Clinical Trial (FACT) that focused on vein dilation in stage 4 patients with chronic renal failure. The p-FACT substudy evaluated the use of the company's FA-1 intermittent pneumatic compression device to promote superficial vein dilation in patients with chronic kidney disease to enable creation of all types of arteriovenous fistulas (AVFs) and to ensure the safety of the device in this patient population. According to the company, the p-FACT data show clear evidence that the Fist Assist device dilates the perforator vein.

“This is revolutionary data for the end-stage renal disease (ESRD) community, namely the patients, physicians, and companies associated with endoAVF procedures,” commented FACT investigator John Lucas, MD, in the company's press release. "Larger veins not only make vascular access surgery easier and more likely to succeed, but a larger, dilated perforator vein is essential for the endoAVF to mature properly. Both endoAVF technologies presently approved and available for treatment of ESRD utilize the perforator vein as a key component of the procedure."

Dr. Lucas, who is a vascular access surgeon in Greenwood, Mississippi, continued, "The statistically significant p-FACT data demonstrates that intermittent compression results in a larger perforator vein for stage 4 patients. Based on the FACT trial p-FACT data, almost every stage 4 renal disease patient planning to have having an endoAVF procedure should consider using the FA-1 device in preparation for their procedure. Larger veins, especially the perforator vein, will surely improve outcomes."

"This is very exciting data for all patients and the global ESRD community," concluded Dr. Lucas.

Tej Singh MD, Chief Executive Officer and Founder of Fist Assist Devices, added, "We are thrilled to announce the results of the p-FACT data. The statistically significant data, with a P value of < .05, shows that the FA-1 device clearly dilates the perforator vein in stage 4 chronic renal failure patients. This is very important data as it not only shows that the FA-1 device is safe, the data also demonstrates that intermittent pneumatic pressure dilates superficial veins including, most importantly, the perforator vein needed for endoAVF success. Condition of the perforator vein is critical for endoAVF planning, and we can now show without a doubt that the Fist Assist FA-1 device can dilate that clinically important vein and have a key role in endoAVF consideration and planning!"

The company stated its technology is for intermittent, external wearable pneumatic compression for arm massage and increased vein circulation in the United States and increased forearm vein enhancement and AV fistula dilation/maturation in India, Canada, Europe, Australia, and New Zealand.

On July 8, Fist Assist announced that the FA-1 device would be distributed in the United States via an alliance with Airos Medical, Inc. The device is also distributed in India via an alliance with Medifocus.