Blue Medical said that on placement of the stent a predetermined load of Paclitaxel will be delivered to the vessel wall to support the vessel in adapting to the stent and reducing adverse effects in the first days after implantation.
The team of investigator Dr Jacques Koolen has 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, Dr Peter Smits of Maasstad Hospital Rotterdam.
The drug eluting balloon product in the Pioneer trial delivers drugs at the stent placement only, instead of continous drug delivery by drug eluting stents. This reduces the period that medication is needed, which means total procedure costs are reduced significantly. The new procedure improves 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.
Drug eluting stents, which release drug from the stent surface after implantation, are commonly used to prevent re-closure of the vessel. A downside is that patients are required to take antiplatelet medication daily for a long period with significant discomfort and risks associated.