The U.S. Food and Drug Administration on Tuesday approved Guidant
Corp.'s less-invasive treatment for clearing clogged carotid
arteries, a leading cause of stroke.
Last week, the FDA approved a similar stent system made by Guidant's
competitor, Johnson & Johnson.
The device was approved for use in patients with previous stroke
symptoms or a severely blocked carotid artery, the FDA said, adding
they must also not be candidates for surgical alternatives.
The agency also said Guidant must conduct additional studies on more
patients to evaluate long-term safety and effectiveness. J&J's
approval also required a follow-up study.