Abbott Stent Needs More Safety Study, FDA Panel Says (Update1)

By Lisa Rapaport and Elizabeth Lopatto


Nov. 29 (Bloomberg) -- Abbott Laboratories' experimental heart stent hasn't been studied enough to ensure its safety beyond one year of use, a U.S. advisory panel said.

Outside experts for the Food and Drug Administration at a meeting today urged additional data to show the device, called Xience, doesn't cause potentially fatal blood clots. The panel will vote later today on whether to recommend approval. The FDA generally follows the advice, though it isn't required to do so.

The agency is considering whether to clear Xience to compete with Boston Scientific Corp.'s Taxus and Johnson & Johnson's Cypher, the two drug-coated stents on the U.S. market. Sales of the devices, used to prop open diseased heart arteries, plunged 40 percent to $2 billion in the U.S. last year over concerns they caused fatal blood clots. Abbott said today it plans to follow patients with Xience for five years, including studies that are already under way.

``We cannot say there is adequate assurance of safety in absolute terms,'' FDA panel chairman Clyde Yancy, medical director of Baylor Heart and Vascular Institute in Dallas, said at the meeting today. ``The data submitted does provide adequate assurance up to 12 months. Beyond 12 months, half the panel believes there is insufficient data, but that doesn't mean we think the device is inherently unsafe.''