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From the Food and Drug Administration
January 3, 2001

Devices for In-Stent Restenosis

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Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001American Medical Association

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JAMA. 2001;285(1):34. doi:10.1001/jama.285.1.34

The FDA has approved two new devices for delivery of radiation to treat in-stent tissue growth following restoration of blood supply to a blocked coronary artery. Both brachytherapy systems are designed to be placed at the site of the in-stent restenosis following opening of the blockage with a balloon, atherectomy, or excimer laser catheter. The radiation treatment is intended to prevent exaggerated healing response at the site and recurrence of significant blockage within the stent.

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