Medical device industry titan Boston Scientific (NYSE:BSX) won expanded CE Mark approval in the European Union to update the directions for use on its Promus Element and Promus Element Plus coronary stents.
The new labels can include 3-month dual anti-platelet drug therapy for certain patients, and Boston Scientific plans to introduce the new labeling in CE Mark countries, according to a press release.
Although company executives said in a prepared statement that they were "pleased" with the new approval, they noted the importance of clinical guidelines for DAPT therapy.
"Current European [Society] of Cardiology guidelines recommend 9 to 12 months of DAPT, with a minimum of 6 months for those who received a drug-eluting stent," according to a press release. "The American Heart Assn. and American College of Cardiology recommend up to 12 months of DAPT for DES post-stent implantation."
Boston Scientific used the occasion of its new labeling to note that its next-generation Synergy stent may address some of the issues associated with durable stent polymers, such as those on Promus Element and Promus Plus, by using a bioresorbable polymer that dissolves within 3 months of implantation.
"This update to our labeling highlights that the need still exists for a drug-eluting stent that reduces the risks associated with long-term durable polymer exposure," interventional cardiology division president Kevin Ballinger said in prepared remarks. "We believe our next generation Synergy Stent, with its unique PLGA bioabsorbable polymer, will address that need."
The Synergy device is not yet approved for the U.S. or European markets.
Boston Scientific could use a win in its stents corner, where 3rd-quarter sales of its domestic coronary stent systems (both drug-eluting and bare metal) were off 35% , international sales were off 14% and total global sales were off 24%.
Company officials tempered the news of the drop-off, saying it was primarily due to a strong comparison to the prior year’s quarter, when the Ion stent was launched during Q2 2011.
BSX shares were up 0.4% to $5.12 as of about noon today.
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