FSS’ FlexStent Iliac system receives CE Mark

Flexible Stenting Solutions, Inc. ("FSS"), a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced today that it has extended its CE Mark authorized family of peripheral vascular stents to include the FlexStent^® Iliac Self Expanding Stent System.    

The FlexStent^® Iliac Self Expanding Stent System is indicated for the treatment of symptomatic atherosclerotic disease of the common and/or external iliac arteries. With this product line extension, the FlexStent^® family of peripheral vascular stent systems now includes stent diameters of 5, 6, 7, 8, 9 and 10 mm, and offers the physician additional options in the treatment of patients with peripheral artery disease (PAD) of the iliac, superficial femoral and popliteal arteries.

The addition of the FlexStent^® Iliac Self Expanding Stent System to the FSS CE Mark authorized family of peripheral vascular stents enhances marketing opportunities for FSS products in the European medical device space. Market launch of the FlexStent^® Iliac Self Expanding Stent System in Europe is expected in Q3 2012.

As with the FlexStent^® Femoropopliteal Self Expanding Stent System, the FlexStent^® Iliac Self Expanding Stent System is an innovative, nearly fully connected, flexible, strong and durable nitinol stent delivered from a straightforward stent delivery system. In addition to simplicity and ease of use, the 6 French / .035" over the wire delivery system provides the physician with a means for very accurate stent deployment.

"FSS continues to be customer focused which means developing effective, easy-to-use stenting systems," commented Bradley Beach, FSS's Chief Operating Officer and co-inventor on all FSS technologies. Janet Burpee, FSS's CEO, further stated that "The extension of the FlexStent^® family of peripheral vascular stents to include sizes indicated for the treatment of the iliac artery is one more realization of the utility of this truly unique 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."