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Self-Expanding Peripheral Stent System Receives Approval
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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.
The device is indicated for the improvement of luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries (up to and including 100 mm in length, with a reference vessel diameter of 7.5 mm to 100 mm), according to the FDA.
The stent system should not be used in patients who are not suitable candidates for balloon angioplasty or stent placement, those not indicated for anticoagulation, those with allergies to metals in the stent, and those with a blockage that will not allow complete inflation of the angioplasty balloon or proper placement of the stent.
The manufacturer is required to report any adverse events related to the stent system, and the Center for Devices and Radiological Health will continue to evaluate its safety and effectiveness, according to the FDA.