Life turns upside down for people diagnosed with end-stage renal disease (ESRD) when they learn that dialysis is their only lifeline for survival. For many patients, this life-altering news is often coupled with another major change – a profound loss of control. ESRD patients face a long journey ahead with hours-long treatments at dialysis centers, multiple times per week, for years on end to ensure their bodies remain in-balance.

Vascular access is a critical component to ensure patients receive dialysis, and our job as interventionalists is to help preserve, maintain and restore this access. For approximately 50 years, the standard of care has been to create an arteriovenous (AV) fistula via surgery by connecting a vein and artery to increase blood flow to the vein in order to perform dialysis. However, new technology has recently become available that arms interventionalists with a non-surgical approach to create an endovascular arteriovenous fistula (endoAVF).

The WavelinQ^™ 4F EndoAVF System, BD’s next generation device, uses two thin, flexible, magnetic catheters which are inserted in adjacent blood vessels in the arm via the ulnar artery and ulnar vein, or the radial artery and radial vein, under X-ray guidance. A small burst of radiofrequency energy is used to create a channel between the artery and vein to create an endoAVF. Once complete, the catheters are removed and blood will flow from the artery to the vein, enhancing blood flow to support hemodialysis. An embolization procedure, which is a procedure that will block a vein to redirect blood flow more effectively, is then recommended.

Most importantly, this new technology offers additional locations to create an AV fistula, while leaving future standard surgical AV fistula creation options open. The endovascular approach is performed through two small punctures or incisions and eliminates the surgical scar that is a common result of open surgical AV fistula creation. An endoAVF is an option for patients who have concerns with traditional surgery for AV fistula creation.

After more than 50 years, we finally have an opportunity to give our patients a minimally invasive alternative to traditional surgery and a small piece of control back when it comes to managing their dialysis. We can help patients with options for dialysis access creation and help them feel empowered and part of the decision-making process to choose the right vascular access creation option for them.

WavelinQ^™ 4F EndoAVF System

Indications

The WavelinQ^™ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

Contraindications

Target vessels < 2mm in diameter.

For more information, visit the WavelinQ^™ 4F EndoAVF System page.
For product safety and risk information, please review the WavelinQ^™ 4F EndoAVF Information for Use.