HELMOND, The Netherlands, May 25, 2010 /PRNewswire/ — Blue Medical
today announced a major step forward in its quest to improve the
quality of life of patients with cardiovascular disease, with the
start of the PIONEER trial, in which a new safe concept of
stent-drug combination is evaluated.
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.
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,
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
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