First Coronary Stent on Drug Eluting Balloon Implanted

By Blue Medical, PRNE
Monday, May 24, 2010

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 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.

NOTE FOR THE EDITOR

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 /
info at bluemedical.com

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