Flexible Stenting Solutions (FSS), a developer of flexible peripheral arterial, venous, neurovascular and biliary stents, has gained CE mark approval for the FlexStent Iliac Self Expanding Stent System to treat symptomatic atherosclerotic disease of the common and / or external iliac arteries.
The FlexStent Iliac Self Expanding Stent System, which is delivered from a straightforward stent delivery system, is a nearly fully connected, flexible nitinol stent.
Janet Burpee, FSS CEO, said the extension of the FlexStent family of peripheral vascular stents to include sizes indicated for the treatment of the iliac artery is one more realisation of the utility of the stent design platform.
"FSS’s continued goal is to work towards expansion of the indications of this unique stent and simplify the peripheral vascular stenting procedure so the physician can focus on the patient," Burpee added.
The company expects to launch the 6 French / .035" over the wire delivery system, which enables accurate stent deployment by physician, in the third quarter of 2012 in the Europe.
With CE mark approval, the FlexStent family of peripheral vascular stent systems offers additional options to the physicians in the treatment of patients with peripheral artery disease (PAD) of the iliac, superficial femoral and popliteal arteries through stent diameters including five, six, seven, eight, nine and ten millimetres.