Trial Examines Coronary Stent Delivered by Drug-Eluting Balloon


May 25, 2010

May 25, 2010 – The first patient has been implanted with a bare metal coronary stent mounted on a drug-eluting balloon in the European Pioneer trial, which began this week.

During stent placement, a predetermined load of the antiproliferative drug paclitaxel is delivered to the vessel wall to help prevent vessel scaring tissue growth inside the stent. The Pioneer drug-eluting balloon is designed to deliver a cobalt chrome alloy bare metal stent.

The team of investigator Dr. Jacques Koolen enrolled the first patient in the Catharina Hospital Eindhoven. This will soon be followed by enrollment in five additional centers in the Netherlands under guidance of the Principal Investigator Peter Smits of Maasstad Hospital Rotterdam.

The drug-eluting balloon product in the Pioneer trial delivers drugs at the stent placement only, instead of continuous drug delivery by drug-eluting stents. This reduces the period that medication is needed, which means total procedure costs may be reduced significantly. The new procedure is supposed to improve a patient's comfort, as the period for which he has to take daily antiplatelet medication is reduced from up to two years to one month.

Blue Medical has developed two drug-eluting balloons, the Pioneer and the Protégé angioplasty balloon.

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