Boston Scientific's Promus Element stent wins CE Mark

November 2, 2009 by MassDevice staff

The third-generation platinum-chromium drug-eluting stent to immediately hit the market in the European Union, just before its private-label deal with Abbott for the original Promus expires.

Boston Scientific said it will immediately begin to market its Promus Element drug-eluting stent in the European Union, now that it's won CE Mark approval for the device.

The news comes just in time for the Natick, Mass.-based medical devices giant, whose deal to put its Promus brand on rival Abbott's Xience V stent is about to expire. It could also help BSX mitigate the damage to its share of the DES market after recent studies indicated that paclitaxel, the drug it uses to coat its Taxus stent line, is less effective than the Promus Element's everolimus coating.

Boston Scientific said its putting the Promus Element stent through its paces in the Platinum clinical trial, a 1,500-patient study comparing the device with an earlier, cobalt-chromium alloy Promus model that uses the same drug dose and polymer. A pair of parallel sub-trials will evaluate the Promus Element in small vessels and long lesions.

Food & Drug Administration approval of the Promus Element could come as soon as 2012, the company said, with CE Marking for the Taxus Element expected during the second quarter of 2010. FDA approval for the latter stent is expected some time in 2011.

Boston Scientific shares were trading at $8.17 as of about 10 a.m. Nov. 2, up half a cent or 0.62 percent from the day's opening price.