Boston Scientific (NYSE:BSX) added another product to its recent string of regulatory approvals, announcing European CE Mark approval and immediate commercial launch for the company’s Agent paclitaxel-coated balloon catheter.
The device, which is essentially a drug-laced version of the company’s Emerge balloon platform, was approved in treatment of both in-stent restenosis and de novo small vessel coronary disease, Boston Scientific announced today.
The Emerge balloon dilation catheters won FDA clearance and CE Mark approval in 2012 for treatment of coronary artery disease. The new Agent balloon is not yet cleared for the U.S. market.
The Massachusetts medical device maker has been on a roll, announcing one regulatory win after another this month. Earlier this week the company announced FDA approval for its Rebel bare-metal stent and earlier this month Boston Scientific landed CE Mark approval for a new mid-size version of its Lotus aortic valve. Just before that the company touted CE Mark for its Ranger drug-eluting balloon.
BSX shares were up 1.5% today, trading at $13.21 as of about 3:25 p.m. EST after the company saw positive momentum from a Wall Street-beating 2nd-quarter financial report and a heightened outlook for the year.