Boston Scientific Corp. (BSX) recently launched the TAXUS Element Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The company’s third-generation drug-eluting stent (DES) received CE Mark approval in May 2010. The TAXUS Element Stent System was designed for coronary stenting and combines the performance of the Element Stent platform with the time tested clinic success of the TAXUS program.
The TAXUS Element Stent System can also be used for patients who are suffering from diabetes, which affects about a third of all patients with coronary artery disease in Europe. Medical practitioners believe that patients suffering from both diabetes and coronary artery disease tend to have less favorable outcomes from revascularization procedures.
Earlier, in March 2010, Boston Scientific announced results from its PERSEUS clinical program comparing outcomes in workhorse lesions for the TAXUS Element Stent System with the TAXUS Express2 Stent System. The results showed similar safety profile and statistically superior efficacy outcomes in small vessels for the TAXUS Element Stent system compared to the control group.
Boston Scientific received, in October 2009, CE Mark approval for its PROMUS Element Everolimus-Eluting Stent System, which has many similar features as the TAXUS Element Stent System.
With regards to approval from the US Food and Drug Administration (FDA), Boston Scientific expects approval for the TAXUS Element Stent System in mid June 2011 followed by approval for the PROMUS Element Stent System in mid 2012. With regards to regulatory approval in Japan, Boston Scientific anticipates approval for the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS Element Stent System in mid 2012. Both devices are, at present, investigational devices in the US and Japan.
We currently have a Neutral rating on Boston Scientific.
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