FDA OKs Guidant's carotid stent system

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The FDA has approved Guidant Corp.'s RX ACCULINK carotid stent system and RX ACCUNET embolic protection system designed to reduce the risk of stroke associated with carotid artery disease.

According to Guidant, the new carotid stent system will provide a minimally invasive treatment alternative to conventional open carotid artery surgery to patients who are at high surgical risk. High-risk patients indicated for carotid stenting include those with significant heart, kidney or lung disease, recurrence of a blockage following a prior carotid surgery, or with difficult-to-access neck anatomy, said Guidant.

The traditional surgical treatment for carotid artery disease usually entails general anesthesia and involves an incision in the patient's neck and artery to remove plaque from inside the vessel wall.

In contrast, during a carotid stenting procedure, the embolic protection system is positioned and a stent is deployed using a catheter inserted into a small puncture in the patient's groin. The patient usually remains conscious while the stent is implanted at the site of the blockage. The embolic protection system is designed to capture and remove particles of plaque that might be dislodged during the procedure.