FDA-approved fist assist device
Patients with chronic kidney disease (CKD) progressing from chronic disease stage 4 to stage 5 end-stage renal disease (ESRD) usually require dialysis when stage 5 is reached.When this happens, they need the veins to be in good shape, especially 2 or 3 mm or larger for proper treatment: they need good fistula, the arteries are connected to the veins in the arm so they can be on dialysis. According to experts, a healthy vein size is helpful for fistula placement.
Many patients in this population are older (in their 70s and 80s) and their veins may not meet the criteria for a good fistula due to age or trauma from past treatment with these veins. If they don’t have a proper vein, the current standard of care is to exercise to increase the vein diameter, such as having the patient squeeze a ball in their hand or have them make a fist.
However, patients often have difficulty adhering to these exercises, resulting in The results are inconsistent at bestThere is a high risk for the patient to find a way to fit a vein: failure to do so will eventually lead to placement of a central venous catheter for dialysis, which is painful and carries the risk of infection and central venous stenosis.
Enter the Model FA-1 device from Fist Assist in Las Vegas, a wearable arm massager that add loop, for patients with chronic renal failure. Specifically, FA-1 is an i
“No company has given any enthusiasm or concern for the need for veins in the arm,” Tej Singh, CEO and founder of Fist Assist Devices, said in an interview. “No company has ever made this kind of drug for kidney failure or infusions. Equipment. We had a product and a lot of people said to me, ‘Why didn’t I think of this?’”
it seems there are other Method for creating a fistula in a hemodialysis patient.
While effective, FA-1 is not a solution for the day of surgery. To get the necessary benefit from the device, patients should wear it for 30 minutes in the morning and another 30 minutes in the evening for four weeks until any treatment or procedure — from blood draws to placement of fistulas to IVs needed to place medications deliver goods. Arm veins are the entry point for many critical medical conditions, Singh said. Ideally, patients wear it for an hour at a time for best results.
FDA approved trial Fist Assist’s FA-1 device was found to effectively dilate perforating veins, which facilitates endoAVF placement and may lead to improved hemodialysis success and endoAVF patency rates. EndoAVF is a novel method for creating fistulas in the elbow region with a minimally invasive method. The trial explained that EndoAVF proved to be a safe hemodialysis option, and a potential challenge with endoAVF placement was insufficient perforating vein diameter. Ultimately, the trial declared that Fist Assist’s FA-1 device was safe, simple, effective and cost-effective. As a result, it may increase the use of endoAVF in the future and provide cost savings for CKD globally, according to trials and trials. other research.
In December 2021, Fist Assist received Breakthrough Device Designation A wearable venous dilation device from the FDA for patients with end-stage renal disease (ESDR).
The FA-1 is an FDA 510k-approved device in the U.S. that increases local arm circulation by intermittently compressing the arm, and its application may improve not only dialysis, but blood draws and cancer care outcomes. The device is already CE marked and is being sold in India. Sales in Australia will follow, according to Singh, for indications such as venous dilation and vascular access maturation.
On May 1, Fist Assist is expected to launch a crowdfunding round to raise funds for the official sale launch. So far, family members have personally funded the company without any venture capital infusions, Singh said. That’s Singh’s belief in this product and its potential to revolutionize patient care.
“We’ve directed the entire company to the point of sales and marketing. Say put the money on your arm, right?” he said.
Singh is already considering the next iteration of the product, which will include a wristband compatible with running and other sports, so patients have more mobility while wearing it.
Photo: Fist Assist
