Fist Assist Devices, LLC Announces Release of the p-FACT Cohort Data

Fist Assist Devices, LLC, announces that data associated with the p-FACT cohort, a data subset of the recently completed, non-significant risk Fist Assist Clinical Trial (FACT Trial) that focused on vein dilation in stage 4 patients with chronic renal failure, shows clear evidence that the Fist Assist device dilates the perforator vein. The p-FACT data derived from the FACT trial evaluated the use the FA-1 device developed by Fist Assist Devices, LLC, a novel, intermittent pneumatic compression device, to promote superficial vein dilation in patients with chronic kidney disease to enable creation of all types of arteriovenous fistulas and to ensure the safety of the device in this patient population.

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,” said Tej Singh M.D., M.B.A., Chief Executive Officer and Founder of Fist Assist Devices, LLC. “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!”

“This is revolutionary data for the ESRD community, namely the patients, physicians, and companies associated with EndoAVF procedures,” said Greenwood, Mississippi vascular access surgeon and FACT Investigator Dr. John Lucas. “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 end stage renal disease utilize the perforator vein as a key component of the procedure. 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.”

Medical Device News Magazine
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy