www.fdanews.com/articles/172373-emba-gets-ce-mark-for-hourglass-embolization-device
Emba Gets CE Mark for Hourglass Embolization Device
July 30, 2015
Emba Medical Limited has received CE Mark approval for its Hourglass Embolization Device, the Dublin-Ireland company announced Wednesday.
The device represents a breakthrough in peripheral embolism devices because it provides precise, secure, over-the-wire delivery and immediate occlusion with a single integrated device, the company claims.
Device co-developer Andrew Cragg says its unique design was created to take advantage of natural hemodynamic forces to provide immediate, stable occlusions.
The Hourglass is a class IIb medical device that will be manufactured in Miramar, Fla. It is not approved for sale in the U.S. — John Bechtel