April 26th, 2011
FDA Briefs: New Stent Approved, Advisory Committee Meeting on ACCORD Lipid
Boston Scientific said on Monday that it had received FDA approval for a third-generation drug-eluting stent, the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System. The “unique platinum chromium (PtCr) alloy” is specifically designed for use in the coronary arteries.
The FDA announced that the Endocrinologic and Metabolic Drugs Advisory Committee would meet on May 19 to discuss the ACCORD Lipid trial. According to the FDA agenda:
The results of the ACCORD Lipid trial indicated that there was no statistically significant difference in the proportion of clinical trial subjects treated with simvastatin plus placebo [versus] simvastatin plus fenofibrate who experienced a major adverse cardiac event. In a prespecified subgroup analysis from the ACCORD Lipid trial, there was an increase in the proportion of female trial subjects treated with simvastatin plus fenofibrate versus simvastatin plus placebo who experienced a major adverse cardiac event. The clinical significance of this finding is unclear. An additional safety concern associated with the use of fenofibrate plus simvastatin, or any other statin, is muscle toxicity.