Non-Surgical Creation of Dialysis Access

Nonsurgical Creation of Hemodialysis Fistula

What Is Hemodialysis?

For nearly half a million patients who suffer from kidney failure, hemodialysis can mean the difference between life and death. Hemodialysis is a procedure where a dialysis machine and a special filter called an artificial kidney are used to clean the body’s blood. For the last 50 years, an invasive surgical procedure was the only way to create an arteriovenous (AV) fistula, an access site to a patients’ bloodstream, which is needed to perform the life-saving hemodialysis treatment.

How It Works

  • Using ultrasound, a physician inserts a small needle into the vein in the upper forearm and advances it into an adjacent artery, then guides the device catheter into place.
  • Once in the artery, the catheter is closed and activated, creating a permanent connection between the vein and artery.
  • The catheter is removed and blood flows through the newly created AV fistula.
  • The patient leaves with an adhesive bandage on their arm and can often return to normal activities the next day.

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End-stage renal disease (ESRD) is the final stage of chronic kidney disease, in which the kidneys can no longer function to filter waste and excess water from the blood.

Hemodialysis is a life-saving treatment for patients with ESRD. More than 700,000 people in the U.S. are living with the disease and 500,000 of these patients undergo hemodialysis treatment to stay alive. Worldwide, there are more than 2.5 million patients with kidney failure requiring this life-saving treatment.

During hemodialysis, blood goes through a filter, called a dialyzer, and the filtered blood is returned into the body. To get the blood into the dialyzer, vascular access, or access to a patient’s bloodstream is needed. AV fistulas are often the preferred method for dialysis vascular access and are created by connecting an artery and a vein in the arm. Previously, the only way to create a fistula was through an open surgical procedure. New non-surgical techniques are used to create dialysis AV fistula.

This procedure offers an approach with the potential to dramatically reduce the amount of time between fistula creation and use of the fistula for dialysis– from about six months with surgical arteriovenous (AV) fistulas to as little as two months with non-surgical procedure. This can potentially accelerate a patient’s ability to receive timely, uninterrupted dialysis.

Frequently asked questions about non-surgical creation of AV fistula:

This device is a catheter system used to create an arteriovenous (AV) fistula for hemodialysis access using a single needle puncture in the arm without the need for surgery. The procedure can be done in hospitals, ambulatory surgery centers and a physician’s office (depending on insurance company requirements). After this minimally invasive procedure, the patient typically leaves with an adhesive bandage on the forearm.

Yes, the non-surgical vascular access system we use is cleared by the U.S. Food and Drug Administration (FDA).

More than 700,000 people in the U.S. are living with end-stage renal disease (ESRD) and 500,000 of these patients undergo hemodialysis treatment to stay alive. A portion of those patients would be eligible to consider endovascular creation of AV fistula. The overall ESRD patient population is growing at a rate of 8% per year.

Hemodialysis is a life-saving treatment for kidney failure that uses a machine to filter the patient’s blood outside the body in a same manner as your own kidney would. The treatment requires access to the patient’s bloodstream, known as vascular access, and is typically performed multiple times per week.

An AV fistula is created by connecting an artery to a vein in the patient’s arm. A fistula is a high blood flow conduit that serves as a vascular access point to enable the removal and return of blood during hemodialysis. An AV fistula is often referred to as a “lifeline” for patients with ESRD.

This procedure is typically performed with a single needle puncture in the arm under ultrasound guidance. The procedure can be performed in hospitals, ambulatory surgery centers, and physicians’ offices in potentially less than 30 minutes by experienced physicians. After the procedure, the patient typically leaves with an adhesive bandage on the forearm and can usually return to normal activities within 24 hours.

The non-surgical AV creation system provides physicians and patients access to a unique non-surgical option for AV fistula creation—a traditionally invasive procedure that, until the introduction of percutaneous fistula creation technologies, had not changed in the last 50 years.

This also expands the number of clinicians that can create fistulas including vascular interventional physicians as well as vascular surgeons, since it is a quick, minimally invasive procedure rather than a surgery.

Potential complications and outcomes that may be associated with creation or maturation of an arteriovenous fistula include, but may not be limited to the following:

  • Total occlusion, partial occlusion or narrowing of the fistula or adjacent veins
  • Failure to achieve fistula maturation (meaning the connection between artery and vein is not adequate for dialysis)
  • Steal syndrome in which the fistula causes reduction of blood flow to hand causing pain and coldness of hand
  • Hematoma which is bleeding under skin
  • Infection or other complications
  • Need for surgical vessel superficialization in which the AV fistula needs to be surgically brought up closer to skin surface
  • Need for additional maturation procedures to get the AV fistula ready for hemodialysis use
  • Not all patients may be candidates for this procedure based on their vascular anatomy.


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