June 28, 2012—Flexible Stenting Solutions, Inc. (FSS, Eatontown, NJ) announced that it has received CE Mark approval for its FlexStent iliac self-expanding stent system, which is indicated for the treatment of symptomatic atherosclerotic disease of the common and/or external iliac arteries. The European market launch of the FlexStent iliac system is expected in the third quarter of 2012.
According to FSS, the FlexStent iliac self-expanding stent system is a nearly fully connected, flexible, strong, and durable nitinol stent delivered from a straightforward stent delivery system. The 6-F, 0.035-inch over-the-wire delivery system provides accurate stent deployment.
The company stated that this approval extends the FlexStent family of peripheral vascular stent systems, which now includes stent diameters of 5, 6, 7, 8, 9, and 10 mm, and offers additional options in the treatment of patients with peripheral artery disease of the iliac, superficial femoral, and popliteal arteries.
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