Boston Scientific ($BSX) has received the FDA's OK for the Promus Element system everolimus-eluting stent, which the company will begin marketing immediately. The transition to the Promus Element shows Boston Scientific's commitment to shifting to internally manufactured everolimus-eluting stents in the U.S.
The Promus Element stent was backed by the Platinum clinical program, which included 5 multicenter studies and more than 1,800 patients worldwide. In April, 12-month results from the randomized, controlled Platinum Workhorse trial demonstrated the Promus Element stent's clinical noninferiority versus the Promus stent in treating de novo coronary artery lesions while also showing a procedural benefit of reduced rates of geographic miss and unplanned stenting.
"This approval marks an important milestone for Boston Scientific--the beginning of a transition to higher margins on our everolimus stent offering in the U.S. as we shift from the PROMUS Stent to the internally manufactured PROMUS Element Plus Stent System," said Hank Kucheman, CEO of Boston Scientific, in a statement. "In these challenging markets, this opportunity should represent $200 [million] in additional annualized gross margin contribution for the U.S. and Japan exiting 2012, which is part of the $650 [million] to $750 [million] opportunity for improvements in operating profit expected over the next several years."
Boston Scientific, which is the second-biggest heart-device maker by revenue, had licensed Promus from Abbott Laboratories ($ABT). Abbott sells the device as Xience, as Bloomberg notes. The Illinois-based company recently got the FDA's nod for its next-generation Xience Prime system for the treatment of coronary artery disease.
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