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IDE Approval for Ventana Fenestrated Stent Graft System

by Savitha C Muppala on Sep 11 2011 9:55 PM

Ventana fenestrated stent graft system from Endologix, Inc has received Investigational Device Exemption (IDE) conditional approval from the FDA.

 IDE Approval for Ventana Fenestrated Stent Graft System
Ventana fenestrated stent graft system from Endologix, Inc has received Investigational Device Exemption (IDE) conditional approval from the FDA.
This approval allows the company to commence clinical trials of the device meant to treat juxtarenal and pararenal aortic aneurysms.

This device is a new aortic extension meant to be used with AFX Endovascular AAA system and Xpand renal stent grafts, manufactured by the same company.

Presently, the Ventana and Xpand stent grafts is allowed only for investigation purposes.



Source-Medindia


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