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August 4, 2021
Fist Assist’s FA-1 Compression Device Studied in FACT for Superficial Arm Vein Dilation
August 4, 2021—Fist Assist Devices, LLC, announced completion of the nonsignificant risk trial, Fist Assist Clinical Trial (FACT).
According to the company, FACT evaluated the use of the company’s model FA-1 intermittent pneumatic compression device to promote vein dilation in patients with kidney disease, to enable creation of arteriovenous fistulas (AVFs), and to ensure the safety of the device in this patient population.
The company announced in July 2021 that the FA-1 device would be distributed in the United States via an alliance with Airos Medical, Inc. The device is also distributed in India via an alliance with Medifocus.
Mary Hammes, DO, Associate Professor of Medicine and Director, Chronic Hemodialysis, at the University of Chicago in Chicago, Illinois, served as primary investigator of the FACT study.
“We are ecstatic to complete FACT and are very thankful to all patients, physicians, and hospitals that worked to complete this trial during the COVID pandemic, which was possible as the device is a patient centric, wearable in the home,” commented Dr. Hammes in the company’s press release.
Dr. Hammes summarized the study in the announcement, as follows:
“This is a landmark, global trial evaluating the effectiveness of the FA-1 intermittent compression device on presurgery stage 4 chronic renal failure patients.
“Patients were enrolled in three locations: The University of Chicago Medical Center, Chicago, Illinois; a medical clinic in Greenwood, Mississippi under the direction of Dr. John Lucas; and MS Ramaiah Medical Center under the direction of Dr. Sanjay Desai in Bangalore, India.
“On preliminary analysis, most enrolled patients showed statistically significant superficial vein dilation (P < .05) without any safety concerns.
“This will be a gamechanger for the over 40 million stage 4 chronic kidney disease patients in the United States alone because larger veins will help ensure better AVFs, whether created surgically or by new [endovascular AVF (endoAVF)] procedures. This data will also be the foundation for additional indications of use for the Fist Assist device and continues to add more information on novel ways to increase pre-surgery vein size and distensibility for eventual dialysis.”
John Ross, MD, Director of Regional Medical Center in Orangeburg, South Carolina, added, “This is groundbreaking research that will drive efficiencies in the end-stage renal disease community as it really proves that intermittent compression enlarges superficial veins, and larger veins provide better surgical/endoAVF options and outcomes. Plus, with the recent focus of fistulas being created percutaneously through endoAVF technology, this data is critically important as larger, presurgical veins will enable more patients to be candidates for the less invasive endoAVF procedures. This data could and should even drive [Centers for Medicare & Medicaid Services] reimbursement as larger superficial veins will help improve outcomes, which drastically reduces the cost burden on the patient, providers, and the entire health care system.”
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