Fist Assist Devices Receives FDA “Breakthrough Device” Designation for the World’s First Wearable Vein Dilation Device for ESRD Patients

The FA-1 is the world’s first wearable device 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.

Access to the FA-1 Device by patients with an ESRD vein dilation indication is now expedited through the FDA Breakthrough Device Program, which 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 Fist Assist Devices, LLC with priority FDA review and interactive communication regarding device development, clinical data, and future indication applications during the premarket review process.

“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,” said Hrishikesh Gadagkar, Ph.D., Fist Assist regulatory advisor and CEO, Idonea Solutions. “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 Fist Assist Model FA-1 device is a wearable, intermittent pneumatic compression device that is worn on the arm to promote vein dilation. The device compresses the outflow vein, which has both biological and physiological benefits, and because it is automated, the FA-1 device significantly improves patients’ compliance compared to other vein dilation alternatives.

“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.”

About End Stage Renal Disease

According to KidneyX (www.kidneyx.org), a public-private partnership between the United States Department of Health and Human Services and the American Society of Nephrology, approximately 40 million adult Americans are currently have chronic kidney disease, and each year more than 100,000 Americans begin hemodialysis as a result of kidney failure.

About Fist Assist Devices, LLC

Fist Assist Devices is a privately held company from Silicon Valley, California that has developed the Fist Assist technology over the past 30 years. The Fist Assist technology is patent protected and is focused on developing an 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. The Fist Assist FA-1 device is distributed in India via an alliance with Medifocus (http://medifocusindia.com) and in the United States via an alliance with AIROS® Medical, Inc. (www.airosmedical.com).

For further information, connect to www.fistassistdevices.com.