Technology | Stents | April 03, 2019

New Indication Added for Covered Stent to Treat Hemodialysis AV Fistula

The U.S. Food and Drug Administration (FDA) recently granted an additional indication to Bard Peripheral Vascular's Covera Vascular Covered Stent for the treatment of a stenosis or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an arteriovenous (AV) fistula.

April 3, 2019 — The U.S. Food and Drug Administration (FDA) recently granted an additional indication to Bard Peripheral Vascular's Covera Vascular Covered Stent for the treatment of a stenosis or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an arteriovenous (AV) fistula.

The device was previously approved for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arterio-venous (AV) access grafts only. 

It is an expandable, flexible, metal (nitinol) tube-shaped device (stent) that is covered with a material called expanded polytetrafluoroethylene (ePTFE). Each covered stent is mounted on the end of a delivery catheter system.

The access circuit begins at the point of surgical connection between an artery and a vein (AV fistula) and ends where the venous drainage of the upper arm enters the chest (i.e., the subclavian vein). The access circuit must remain open to permit hemodialysis treatments. The tent is placed using a balloon catheter

The FDA said the Covera covered stent should benefit patients by keeping the treated area open for a longer time compared to use of balloon angioplasty alone. The covered stent may also reduce the number of procedures needed to keep the same narrowing open, however, additional procedures may be needed for treatment of other narrowings that develop subsequent to the use of this device. The use of the Covera Vascular Covered Stent is associated with little added risk compared with treatment using a balloon angioplasty alone, the FDA said.

For more information: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm634191.htm?utm_campaign=2019-03-25%20Recently%20Approved%20Devices&utm_medium=email&utm_source=Eloqua

Related Content

Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
News | Cath Lab

November 10, 2021 — Shockwave Medical a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely ...

Home November 10, 2021
Home
News | Cath Lab

November 10, 2021 — Philips Healthcare announced North American availability of new innovations in its portfolio of ...

Home November 10, 2021
Home
News | Cath Lab

October 6, 2021 — Boston Scientific Corp. announced it entered into a definitive agreement to acquire Baylis Medical ...

Home October 06, 2021
Home
News | Cath Lab

September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device ...

Home September 21, 2021
Home
Feature | Cath Lab | By Aaron Detate and Lars Thording

In the electrophysiology (EP) lab, hundreds of thousands of used devices are sent to reprocessors every year to get ...

Home September 14, 2021
Home
News | Cath Lab

July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of ...

Home July 22, 2021
Home
Subscribe Now