Becton Dickinson wins FDA 510(k) for Wavelinq 4F endoAVF system

Becton Dickinson (NYSE:BDX) said today that it won FDA 510(k) clearance for its WavelinQ 4 French endovascular arteriovenous fistula creation system.

The Franklin Lakes, N.J.-based company said that the newly cleared WavelinQ 4F endoAVF system features improved technology that allows for the creation of an AVF in either the ulnar artery and ulnar vein or the radial artery and radial vein.

The new ability expands upon the company’s existing indications for its WavelinQ 6F endoAVF system, BD said.

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

“People living with ESRD are an underserved patient population with very limited treatment options available to them. We’re excited to add BD WavelinQ 4F endoAVF system to our portfolio of technologies that create, restore and/or maintain AV access for patients on hemodialysis. Endovascular specialists now have an additional tool that enables the flexibility needed to support AV fistula creation for their patients,” peripheral interventions prez Steve Williamson said in a press release.

Earlier this month, BD posted fiscal year 2019 first quarter earnings that topped expectations on Wall Street.

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