First wearable vein dilation device receives FDA breakthrough device designation
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The FDA granted breakthrough device designation to First Assist Devices LLC for its First Assist Model FA-1 device, according to a press release.
The device is designed to promote arteriovenous fistula (AVF) creation in adults with chronic renal failure before surgical vein dilation. The device can be worn on the arm and creates periodic pneumatic compression. According to the release, it is the first of its kind to receive the FDA designation.
“This designation is another major milestone for Fist Assist Devices LLC. We expect it to change the algorithm for patient care,” Tej Singh, MD, MBA, founder and CEO of Fist Assist Devices LLC, said in the release. “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 chronic kidney disease 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.”
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