Fist Assist Devices has announced that it recently received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Fist Assist Model FA-1 device.
According to the company, the FA-1 is the world’s first wearable 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 haemodialysis access.
Access to the FA-1 device by patients with an end-stage renal disease (ESRD) vein dilation indication is now expedited through the FDA Breakthrough Device programme—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 programme provides Fist Assist with priority FDA review and interactive communication regarding device development, clinical data, and future indication applications, during the premarket review process, according to a press release from the company.
“As this is a first-of-its-kind wearable device for haemodialysis patients focused on presurgery vein dilation, we are ecstatic to have the FDA recognise 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, Fist Assist regulatory advisor and CEO of 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 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. We expect it to change the algorithm for patient care,” said Tej Singh, founder and CEO of Fist Assist. “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 [chronic kidney disease] patients.
“The FA-1 device benefits patients, physicians and healthcare 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 designation gets us one step closer to accomplishing our goals.”