FDA clears system to reduce stroke risk during stent and angioplasty procedures

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA clears system to reduce stroke risk during stent and angioplasty procedures

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FDA clears system to reduce stroke risk during stent and angioplasty procedures

02/09/2015 11:56 AM EST

The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.

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