FDA approves BD’s arteriovenous fistula system

Becton Dickinson & Co. (NYSE:BDX) said that FDA has cleared its WavelinQ 4 French (4F) endovascular arteriovenous fistula (endoAVF) system for people with end-stage renal disease (ESRD).

The 4F endoAVF will allow for the creation of a  fistula in either the ulnar artery and ulnar vein or the radial artery and radial vein, providing a minimally invasive alternative to open surgery, the Franklin Lakes, N.J.-based company said.

With a slimmer profile than BD’s WavelinQ 6F endoAVF system, the 4F version increases a patient’s anatomical AVF location options, enabling additional venous wrist access points (ulnar vein or radial vein) and reducing the risk of scarring or arm disfigurement for patients compared to open surgical AV fistula creation, the company said.

In the U.S. alone, there are more than 440,000 patients with end-stage renal disease who are surviving on hemodialysis, according to the National Institutes of Health.

“People living with ESRD are an underserved patient population with very limited treatment options available to them,” said BD’s worldwide president of peripheral intervention Steve Williamson in a prepared statement. “Endovascular specialists now have an additional tool that enables the flexibility needed to support AV fistula creation for their patients.”

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