Covidien’s Stellarex drug-eluting balloon wins CE Mark

European regulators granted market clearance for Covidien‘s (NYSE:COV) Stellarex drug-eluting balloon for treating peripheral artery disease, the company said today.

Covidien is due to sell the Stellarex assets to Spectranetics (NSDQ:SPNC) as soon as its $43 billion merger with Medtronic (NYSE:MDT) closes, which is expected to occur later this month or in early February.

"PAD is a progressive disease that affects millions of people around the world. [Drug-eluting balloons] are emerging as an alternative to traditional treatment options, such as angioplasty or stenting, because of their ability to restore blood flow, prevent the reoccurrence of new blockages and preserve future treatment options," principal investigator Dr. Henrik Schröeder of Berlin’s Jewish Hospital said in prepared remarks. "In clinical trials, the Stellarex [DEB] has demonstrated promising results with strong patency rates and low reoccurrence of target lesions at 24 months."

The $30 million deal for Stellarex covers the Stellarex angioplasty platform, a paclitaxel-eluting balloon used to treat peripheral artery disease. When the deal was announced Spectranetics said it expected to launch the Stellarex device as soon as it won CE Mark approval, which at time was forecast for late 2014 or early this year.

The device, which uses a drug coating called EnduraCoat designed to prevent drug loss during the procedure, could hit the U.S. market in 2017, the companies said at the time.

Earlier this week, both Medtronic’s and Covidien’s shareholders voted to approve their merger, which must be cleared by the Irish High Court before it can be consummated.