FDA Panel Provides Cautious Support for Drug-Eluting Stents 4184

BUSINESS NEWS

When FDA's circulatory system devices advisory panel met in December to review drug-eluting coronary stents, many industry analysts raised concern that use of the devices could be sharply curtailed given the firestorm of safety issues that had been raised prior to the meeting. Yet, after two days of data review and analysis, the panel adopted a more moderate stance than generally anticipated. Although acknowledging that previous clinical studies of drug-eluting stents indicated a greater incidence of late-term thrombosis than with bare-metal stents, the panel concluded that the magnitude of the greater incidence is uncertain and additional data are needed. Despite the apparent increase in stent thrombosis, drug-eluting stents were not found to increase the risk of death or myocardial infarction compared with bare-metal stents.

The panel also emphasized that drug-eluting stents are generally safe and effective when used as intended.

The consensus of the panel was that safety concerns do not outweigh the benefits of drug-eluting stents, which have demonstrated superiority over the bare-metal variety in reducing the risk of restenosis, the buildup of scar tissue at the site of the artery repair.

Although the panel called for more-detailed postmarket studies on the safety and efficacy of drug-eluting stents, FDA is not expected to implement any changes in the premarket approval process. Thomas Gunderson, managing director and senior medtech research analyst with Piper Jaffray & Co. (Minneapolis), said, "FDA is not likely to now raise the bar for newcomers to the market. The panel is apparently not recommending any changes in procedures or requirements in clinical studies as part of the FDA approval process. The emphasis here is on postmarket surveillance and follow-up."