Boston Scientific Corp. said it gained US approval for a new version of its drug-coated heart stent, a product the company will manufacture itself rather than licensing from a competitor.
Boston Scientific, the second-biggest heart-device maker by revenue, will begin selling the Promus Element stent system immediately, the Natick-based company said today in a statement.
While Boston Scientific had anticipated approval in advance of a mid-2012 target date, the company said it expects to record a $40 million pretax charge in the fourth quarter as a result of the early clearance by the US Food and Drug Administration.
“This approval marks an important milestone for Boston Scientific — the beginning of a transition to higher margins on our everolimus stent offering in the US as we shift from the Promus stent to the internally manufactured Promus Element Plus stent system,’’ Hank Kucheman, the company’s chief executive officer, said in the statement. “We are proud that our research, clinical, regulatory, and manufacturing teams delivered a self-manufactured everolimus stent several months ahead of our goal.’’
Boston Scientific had licensed Promus from Abbott Laboratories, which sells the device as Xience. Sales of Boston Scientific’s stents, devices used to prop open clogged arteries, fell to $198 million in the US in the third quarter from $210 million a year earlier, Boston Scientific reported Oct. 20.
The FDA approved Abbott’s latest version of its drug-coated stent, called Xience Prime, on Nov. 1, the Abbott Park, Illinois-based company said in a statement.
Johnson & Johnson announced in June it will pull out of the $4 billion global market for drug-coated stents by the end of the year after losing ground to Boston Scientific and Abbott.