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Self-expanding peripheral stent system approved by FDA

February 1, 2015

The FDA recently approved a self-expanding peripheral stent system for use in the common iliac, external iliac, superficial femoral and subclavian arteries, according to a press release.

The Protégé GPS Self-Expanding Peripheral Stent System (ev3, Inc.) consists of a stent and delivery system. The nitinol stent comes on a 6F over-the-wire delivery system, and has narrowed edges to avoid irritation or damage to the luminal diameter. The stent has tantalum radiopaque GPS markers on both ends for better visibility and more accurate insertion. The system also features a catheter with zones of varying flexibility and a soft, flexible tip designed for catheter advancement and placement, according to information from the company. Once in place, the stent permanently holds open a narrowed iliac artery and improves blood flow to the pelvis and legs.

William Maisel FDA News

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