Everflex: FDA Releases Summary Documents

Last week we covered FDA’s clearance of Covidien’s Everflex™ peripheral vascular stent here. Now the agency has released summary information pertaining to the use of the product. The information can be found here and confirms that the Self-Expanding Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 180mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 – 7.5mm.

The stent was approved based largely on the results from the DURABILITY II study, with a requirement that Covidien continues to monitor the study data on a six monthly basis for the first two years post-approval and annually thereafter.

Source: FDA