Boston Scientific Corporation (NYSE: BSX) today welcomed the online release of several important articles scheduled for publication in the March 8th edition of the New England Journal of Medicine (NEJM).
These articles confirm the safety and efficacy of the Company’s TAXUS(R) Express2(TM) paclitaxel-eluting coronary stent system (TAXUS Stent) when used for the indications included in its approved labeling. The TAXUS Stent was approved by the U.S. Food and Drug Administration (FDA) in March 2004 for use in first-time lesions up to 28 mm in length in coronary vessels between 2.5 and 3.5 mm in diameter.
In total, the findings support Boston Scientific’s own internal analyses, publications, physician communications and public presentations of the TAXUS trial data, showing that patients who received the TAXUS Stent for on-label indications had nearly a 50 percent reduction in the need for repeat procedures to treat vessel renarrowing, with no increase (in-fact a slight numerical decrease) in the risk of all-cause death or large heart attack, compared to the patients who had received the “control” bare-metal stent (BMS). These findings had previously been verified by independent examination of the data, and are now further confirmed by the additional independent analyses reported by Drs. Mauri et al, and Dr. Stone et al in the NEJM.
“This collection of information extends and solidifies our understanding of the role of drug-eluting stents by reaffirming the small magnitude of any increase in stent thrombosis, confirming the absence of an associated significant risk of death or heart attack for on-label indications, and calling for individualized physician decisions regarding the use of drug- eluting stents versus alternative revascularization approaches in currently off-label or extended use, until definitive trials for those uses are completed,” said Donald S. Baim, M.D., Chief Medical and Scientific Officer for Boston Scientific.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.