Blue Medical has started Pioneer trial, in which a new safe concept of stent-drug combination is evaluated to improve the quality of life of patients with cardiovascular disease.
Pioneer, as part of Blue Medical’s clinical program, is the trial that enables for the first time the delivery of a coronary stent that is mounted on a drug eluting balloon.
On placement of the stent a predetermined load of Paclitaxel is delivered to the vessel wall to support the vessel in adapting to the stent and reducing adverse effects in the first days after implantation.
Blue Medical said that 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.
A coronary balloon angioplasty is a minimally invasive procedure performed to improve blood flow to the heart muscle. In an angioplasty procedure a balloon is inflated to open the coronary artery. In addition, a small wire mesh tube, called a stent, may be permanently placed to help the artery to remain open. 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.