Novel, Intermittent Compression Device Clinical Trial Aims to Prove
Vein Dilation to Improve Fistula Outcomes in Patients with Stage 4
Kidney Disease
LOS ALTOS, Calif.–(BUSINESS WIRE)–Fist Assist Devices, LLC, a novel medical device startup based in
Silicon Valley, Calif., today announced the approval of FACT (Fist
Assist Clinical Trial) by the University of Chicago Medical Center
Institutional Review Board (IRB). This research will evaluate the
effects of using the Fist Assist® device to develop
superficial veins prior to arteriovenous fistula (AVF) creation for
patients with end-stage renal disease (ESRD) by either surgery or new
endovascular procedures.
The Fist Assist® device is the only wearable, patent-protected
intermittent compression device that supports vein dilation for patients
with ESRD. The non-invasive device applies intermittent pressure to a
specific superficial arm vein to help dilate the vein prior to surgical
or endovascular fistula placement. As extensively studied, larger veins
before fistula creation can ensure that the fistula reaches optimal size
without delays or extra procedures, ultimately reducing costs for both
patients and dialysis providers.
“This truly is an exciting time for our company. Partnering with Dr.
Mary Hammes, Associate Professor in the Department of Nephrology at the
University of Chicago, and her colleagues is a great opportunity to
conduct this pioneering research at the Medical Center where the concept
for the device was formulated more than 30 years ago,” said Tej Singh
M.D., CEO and Founder of Fist Assist Devices, LLC. “We are confident
that Dr. Hammes and her team will conduct a high-quality study that will
serve as the foundation for our FDA de novo submission. This
non-significant risk trial will be carefully watched by many, including
Fist Assist Devices, LLC’s newly created Medical Advisory Board.”
Today, renal failure affects about 20 million people in the United
States, and it is expected to affect 4.9 million patients globally by
2025,1 and many of these cases will progress to ESRD.
Currently, 437,000 patients in the United States receive hemodialysis
treatment for ESRD, and an additional 150,000 patients are expected to
be added to this number annually.2 These statistics
demonstrate the urgent need to find more effective methods to promote
vein dilation and develop cost-effective, non-invasive devices to help
AVF mature and prevent renal failure.
“We are delighted to conduct the FACT trial and work with the Fist
Assist device,” said Dr. Mary Hammes, Associate Professor of Medicine,
Director, Chronic Hemodialysis at the University of Chicago. “The Fist
Assist device is a groundbreaking device for patients with end-stage
renal diseases. We hope our study demonstrates the significant benefit
of the device to patients, providers and everyone affected by ESRD.”
About Fist Assist Devices, LLC
Fist Assist Devices, LLC is a privately held company located in Silicon
Valley, Calif. that has developed the patent-protected Fist Assist
technology over the past 30 years. Fist Assist Devices, LLC is focused
on developing and marketing an intermittent, external wearable pneumatic
compression to increase arm vein enhancement and AV fistula dilation.
The device is currently approved for sales in India, but is not yet
commercially available in Europe or the United States.
For further information, connect to https://www.fistassistdevices.com.
About University of Chicago Medical Center
The University of Chicago Medical Center , with a history dating to
1927, is a not-for-profit academic medical health system based on the
campus of the University of Chicago in Hyde Park, and with hospitals,
outpatient clinics and physician practices throughout Chicago and its
suburbs. University of Chicago Medical Center has a nationally
recognized nephrology program that is led by physicians with unmatched
expertise in the region and whose commitment to scientific research
means patients have access to emerging kidney disease therapies not
widely available.
For further information, connect to www.uchicagomedicine.org.
| 1 |
Fresenius Medical Care, www.freseniusmedicalcare.com/en/investors/at-a-glance/outlook/ |
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| 2 |
Centers for Disease Control and Prevention, www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html#calculation |
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Contacts
Tej Singh MD, MBA
CEO & Founder
Fist Assist Devices, LLC
fistassistdevices@gmail.com
(650)
444-2599