Fist Assist Devices has just announced completion of the FACT trial, which evaluated the use of an intermittent pneumatic compression device, model FA-1, to promote vein dilation in patients with kidney disease. The trial’s results suggest the device could enable an increase in the creation of functional arteriovenous fistulas by enlarging superficial veins. The trial also demonstrates the device’s safety in this patient population.
“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 or endoAVF options and outcomes” said John Ross, director of Regional Medical Center in South Carolina and inductee in the American College of Surgeons and Academy of Master Surgeon Educators.
The Fist Assist technology is patent protected and focused on developing an intermittent, external wearable pneumatic compression for arm massage and increased vein circulation in the United States, and increased forearm vein enhancement and AV fistula dilation/maturation in India, Canada, Europe, Australia, and New Zealand.
“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-19 pandemic, which was possible as the device is a patient-centric wearable in the home” said Mary Hammes, primary investigator of the trial and associate professor of Medicine and director, Chronic Hemodialysis, at the University of Chicago, USA. “This is a landmark, global trial evaluating the effectiveness of the FA-1 intermittent compression device on pre-surgery, stage 4 chronic renal failure patients.”
Patients were enrolled in three locations: The University of Chicago Medical Center, Chicago, USA; a medical clinic in Greenwood, USA, under the direction of John Lucas; and MS Ramaiah Medical Center, Bengaluru, India, under the direction of Sanjay Desai.
On preliminary analysis, most enrolled patients showed statistically significant superficial vein dilation (p<0.05) without any safety concerns. A press release from the company states: 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 improved arteriovenous fistula creation, whether they are created surgically or by new EndoAVF procedures. “This data is likely to 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,” the release adds.
Ross outlines the benefits of larger preprocedural veins: “[…] 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 CMS reimbursement as larger superficial veins will help improve outcomes, which drastically reduces the cost burden on patients, providers, and the entire healthcare system.”