FDA clears Promus Element Plus stent

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The FDA has approved Boston Scientific's Promus Element Plus everolimus-eluting platinum chromium coronary drug-eluting stent (DES) system. The company plans to begin marketing the product in the U.S. immediately.

The Promus Element stent, designed to treat patients with coronary artery disease, is built on a platinum chromium (PtCr) platform with the everolimus drug. Promus Element uses a proprietary PtCr alloy designed for coronary stenting, and features a dual-layer balloon and Bi-segment inner lumen catheter. The stent has a fluorinated co-polymer coating.

The Natick, Mass.-based company said it expects to record a pre-tax charge of approximately $40 million ($35 million after-tax) during the fourth quarter of 2011 as a result of the early approval and launch timing of the Promus Element Plus stent system in the U.S., related to inventory reserves which will impact gross margins. This charge was not included in the company's previously issued financial guidance for the fourth quarter.

The Promus Element Plus stent is currently offered in a matrix of 74 sizes, ranging in diameter from 2.25 mm to 4 mm and lengths of 8 mm to 32 mm on both Monorail and Over-the-Wire catheter platforms. The company expects that additional 32 mm and 38 mm stent lengths will be available in mid-2012.

The company received CE mark approvals for the Promus Element stent in October 2009, the Taxus Element paclitaxel-eluting stent in May 2010, and the Omega bare-metal stent in February. They expect to receive regulatory approval of the Promus Element stent and launch the product by mid-2012 in Japan.  In the U.S. the Taxus Element stent is commercialized as the Ion paclitaxel-eluting stent, which received FDA approval in April.