FDA Panel Assesses Drug-Eluting Stents and Clotting

Questions about whether the risks of clotting, heart attacks and death are higher for patients with drug-eluting stents compared bare stents are the subject of a two-day panel by the FDA. The questions center on whether and how long patients with the drug-eluting stents should stay on anti-clotting drugs such as Plavix. In a worst case scenario, the elevated risks, which the FDA does believe exists, could ultimately sabotage a $5 billion market for the devices.

Principal players (with a bevy of newcomers waiting in the wings) Boston Scientific and Johnson & Johnson have different spins on the risk. Boston Scientific “acknowledges a slight increase in clotting associated with its drug-coated stent, the Taxus,” but the company asserts that there is no corresponding increased risk of heart attack or death. Johnson & Johnson argues that the risk of clotting, heart attack or death is equivalent for drug-eluting and bare stents.

The question of increased risk of clotting will certainly influence approvals of pending drug-eluting stents from Medtronic, Abbott and others.

Detailed coverage of the drug-eluting stent market is provided in the October 2006 issue of MedMarkets (subscribers).

Tags: medtech, stents

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