BD’s WavelinQ 4-F endoAVF System Receives FDA 510(k) Clearance

 

February 13, 2019—BD (Becton, Dickinson and Company) announced that it has received FDA 510(k) clearance for its WavelinQ 4-F endoAVF system, which allows the creation of an arteriovenous (AV) fistula in either the ulnar artery and ulnar vein or the radial artery and radial vein in patients with end-stage renal disease (ESRD) on hemodialysis.

The company noted that this clearance expands upon the current indication for its WavelinQ 6-F endoAVF system.

The WavelinQ 4-F endoAVF system provides a minimally invasive option for AV fistula creation due to its low profile and allows more options for AVF anatomic location with additional venous wrist access points (ulnar vein or radial vein). This, in turn, increases procedural flexibility for physicians while reducing the risk of scarring or arm disfigurement for patients compared to open surgical AV fistula creation, according to BD.

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

Last year BD acquired TVA Medical and renamed the everlinQ endoAVF system to its current WavelinQ endoAVF system name. Both the 4- and 6-F WavelinQ endoAVF systems are CE Marked in Europe.

 

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