FDA News

FDA clears WavelinQ 4F endoAVF system

Becton, Dickinson and Company recently announced it has received FDA 501(k) clearance for its WavelinQ 4F endoAVF system.

The system, building on BD’s WavelinQ 6F endoAVF system, lends to the creation of an arteriovenous fistula in either the ulnar artery and ulnar vein or the radial artery and radial vein, which is less invasive than open surgery for patients with ESRD who are on hemodialysis, according to a company press release. The system reportedly reduces the risk of scarring or arm disfigurement that often accompanies open surgical arteriovenous fistula creation.

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

Reference:

www.bd.com/en-us/company/news-and-media/press-releases/feb-13-2019-bd-advances-technology-to-create-endovascular-av-fistulas-for-chronic-kidney-disease-patients-who-require-hemodialysis

Becton, Dickinson and Company recently announced it has received FDA 501(k) clearance for its WavelinQ 4F endoAVF system.

The system, building on BD’s WavelinQ 6F endoAVF system, lends to the creation of an arteriovenous fistula in either the ulnar artery and ulnar vein or the radial artery and radial vein, which is less invasive than open surgery for patients with ESRD who are on hemodialysis, according to a company press release. The system reportedly reduces the risk of scarring or arm disfigurement that often accompanies open surgical arteriovenous fistula creation.

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

Reference:

www.bd.com/en-us/company/news-and-media/press-releases/feb-13-2019-bd-advances-technology-to-create-endovascular-av-fistulas-for-chronic-kidney-disease-patients-who-require-hemodialysis