New Products In Brief

Next-generation everolimus-eluting platinum chromium coronary stent system gains FDA market go-ahead, announced Nov. 22. Marketing will begin immediately, the firm said. The approval comes roughly six months ahead of schedule. Boston Scientific Corp.previously had anticipated approval around mid-2012. The internally manufactured Promus Element Plus will replace Boston Scientific’s previous-generation Promus everolimus-eluting stent, supplied by Abbott, and “should represent $200 million in additional annualized gross margin contribution for the U.S. and Japan exiting 2012,” the company said. Boston Scientific “will receive 100% of the profit from Promus Element, whereas Abbott receives 40% of Promus profit under a licensing agreement,” Wells Fargo analyst Larry Biegelsen noted in a Nov. 23 report. The new system features an enhanced catheter delivery system for improved deliverability over Promus, the company claims. Boston Scientific gained European CE mark approval for the Promus Element stent in 2009; in Japan, the firm expects to receive regulatory approval and launch the product by mid-2012.

Biotronik SE & Co. KG announces Nov. 23 receipt of European CE mark approval of its Lumax 740 series implantable cardioverter defibrillator with ProMRI technology – making them the...