Press Release DEB Products

Press release
FIRST CORONARY STENT ON DRUG ELUTING BALLOON IMPLANTED
Innovation improves patient’s comfort and reduces procedure cost significantly

HELMOND, the Netherlands - May 25, 2010 - 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 during stent
placement only, instead of continous drug delivery by drug eluting stents. This reduces the
period that follow-up medication is needed, which means total procedure costs are reduced
significantly. The new procedure improves 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, that 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.

About Blue Medical
Located in the Dutch Brainport area, Blue Medical (www.bluemedical.com) is a global
medical devices company and innovator in the treatment of cardiovascular diseases.
The company develops, manufactures and markets innovative medical products for
cardiovascular diseases. Every year over 50,000 patients worldwide are treated with devices
of Blue Medical.

 

For further information:

Ronald A.M. Horvers, CEO, +31 492 588 900
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