www.fdanews.com/articles/179478-convertx-nabs-fda-clearance-for-kidney-stent-system
ConvertX Nabs FDA Clearance for Kidney Stent System
November 30, 2016
The FDA has cleared BrightWater Medical’s ConvertX kidney tube stent system for treatment of obstructions.
The device is implanted and converts from a catheter to a stent without the need for radiation or sedation. It then remains implanted in the patient like a standard internal kidney tube stent.
BrightWater Medical is will submit an application for the ConvertX system to the EU for CE marking. — Cynthia Jessup