It is estimated that there are roughly 468,000 are dialysis patients in the United States.
To undergo dialysis, it is necessary to connect the patient to the filtering system through tubes inserted in the body, requiring a regular access site be created on the body.
Access can be gained though a graft (soft tubing that connects a vein and artery in your arm), a Hemodialysis catheter (a tube placed in the neck, chest or groin), or an Arteriovenous (AV) fistula (surgically joining of a vein and an artery in the arm.)
An AV fistula is the most natural access site since it’s formed from your own blood vessels, and has the lowest chance of infection and clotting. Despite these benefits, the healing time for the AV fistula surgery is typically 6-8 weeks (called “maturing”), making it less ideal for some patients.
In June 2018, the FDA approved two devices – Ellipsys and WavelinQ – both used in nonsurgical creation of a dialysis fistula. The minimally invasive procedure retains the benefits of the traditional, surgical method, while eliminating the longer healing time.
This groundbreaking, minimally invasive option for patients with end-stage renal disease, called the Ellipsys EndoAVF procedure, can be performed as an outpatient procedure under conscious sedation, and takes approximately 20-40 minutes.
“Presbyterian/St. Luke’s Medical Center is the first hospital in Colorado to offer this procedure to End-Stage Renal Disease patients,” states Dr. Nick Yee, interventional radiologist with RIA Endovascular Clinic operating at Presbyterian/St. Luke’s Medical Center. “Providing this state-of-the-art technology to our patients is a true game changer that we hope will save and improve the quality of our patients’ lives.”
The FDA trial showed a technical success for fistula creation of 95% and the time between procedure and access to the fistula was 27% shorter than surgically created fistulas. Additionally, the functional access of the fistula was 92% (as compared to 50% of the surgical fistulas) at 12 months.
Read the full press release here.