BD receives FDA 510(k) clearance of WavelinQ 4F endoAVF system

BD has announced the 510(k) clearance from the US Food and Drug Administration (FDA) for the WavelinQ 4F endoAVF system earlier this month. The endoAVF system is the company’s most recent innovation in endovascular arteriovenous fistula (endoAVF) creation technology, which allows for the creation of an arteriovenous fistula in either the ulnar artery and ulnar vein or the radial artery and radial vein, expanding upon the current indication for the the WavelinQ 6F system.

In the USA alone, there are more than 440,000 patients with end-stage renal disease (ESRD) who are surviving on haemodialysis. EndoAVF systems provide clinicians with a minimally invasive arteriovenous fistula (AVF) creation alternative to open surgery. The WavelinQ 4F, with a slim profile, increases the anatomical AVF location options and enables additional venous wrist access points (ulnar vein or radial vein), providing increased procedural flexibility for physicians while reducing risk of scarring or arm disfigurement for patients compared to open surgical AV fistula creation.

“With BD WavelinQ 4F endoAVF system, I can provide my ESRD patients with two additional fistula location options compared to a surgical fistula,” said Paul Kreienberg, Albany Medical Center, Albany, USA. “These additional AV fistula sites and a minimally invasive procedure can increase the likelihood that patients will get a usable AV fistula.”

“People living with ESRD are an underserved patient population with very limited treatment options available to them,” said Steve Williamson, worldwide president of Peripheral Intervention at BD. “We are excited to add BD WavelinQ 4F endoAVF system to our portfolio of technologies that create, restore and/or maintain AV access for patients on haemodialysis. Endovascular specialists now have an additional tool that enables the flexibility needed to support AV fistula creation for their patients.”