ev3 launches Protege EverFlex self-expanding stent system

By Angela McDaniels

Seattle, March 9 - ev3 Inc. said the Food and Drug Administration has cleared for marketing the company's Protege EverFlex self-expanding stent system for the palliative treatment of malignant neoplasms in the biliary tree.

ev3 has also obtained European marketing clearance for general use of the Protege EverFlex in the peripheral vasculature and begun a commercial release of the product throughout Europe, according to a company news release.

The Protege EverFlex is supplied in lengths of up to 150 mm, making it the longest self-expanding nitinol stent available worldwide, the company said.

It is designed to provide durability in challenging clinical situations: ev3 said that in rigorous simulated fatigue testing, the Protege EverFlex survived five to 20 times longer than any competitive stent tested.

"Long stents have the potential to withstand forces better than multiple overlapping stents," Dierk Scheinert of the University of Leipzig Heart Center in Leipzig, Germany, said in the release.

"Through its combination of length and durability, I believe the Protege EverFlex stent system will enable treatment of more challenging lesions."

The Protege EverFlex provides delivery and deployment similar to that of the current Protege stent family, is compatible with a 6 French guiding catheter and is available on a 0.035-inch compatible delivery platform, the company said.

ev3 is a medical device company based in Plymouth, Minn., that develops endovascular technologies for the minimally invasive treatment of vascular diseases and disorders.

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