Blue Medical Receives European CE Mark Approvals for Drug Eluting Balloon and Stent on Drug Eluting Balloon Combination DeviceBy Blue Medical Devices Bv, PRNE
Monday, November 15, 2010
First Ever CE Approved Combination Device is an Attractive Treatment for Coronary Artery Diseases
HELMOND, The Netherlands, November 16, 2010 - Blue Medical today announced that the company received CE Mark approval
for Blue Medical science based Drug Eluting Balloon (DEB) and simultaneously
for Blue Medical's coronary CoCr stent mounted on a Drug Eluting Balloon
(CoCr Stent on DEB) in Europe for treatment of coronary diseases.
DEB therapy delivers a controlled dose of Paclitaxel to the coronary
artery during balloon angioplasty. A unique combination of a one-time short
and precise drug delivery with DEB during placement of a coronary stent is
now for the first time approved and available in Europe.
"Increased late stent thrombosis risk and the long term dual
anti-platelet medication which are associated with the majority of current
drug eluting stents is a concern in treating our patients today," said
Primary Investigator of the PIONEER Study Peter Smits, M.D., head of
Intervention Cardiology at the Maasstad Hospital, Rotterdam, The Netherlands.
"DEB therapy in combination with bare metal coronary stents offers a
potential solution for reducing late lumen loss without the need for long
term dual-anti-platelet medication, improving patent comfort and reducing
risks for bleeding and stent thrombosis."
The CE Mark approval is based on extensive in-vivo research performed
world-wide and preliminary data collected in Blue Medical's clinical trial,
PIONEER. Based on the CE mark, Blue Medical will introduce the CoCr stent on
DEB, called Pioneer and its DEB, called Protege across Europe by the end of
"This CE Mark is the first approval by a regulatory agency for the use of
DEB therapy in combination with a bare metal stent and provides a new
attractive treatment for patients in Europe who are in need of other
options," said Ronald Horvers, CEO of Blue Medical. "We worked closely with
the respected Dutch competent authority CBG and with KEMA as notified body to
ensure a solid science base for this CE approval."
About Blue Medical
Blue Medical (www.bluemedical.com), headquartered in Helmond, The
Netherlands, is a global medical devices company and innovator in treatment
of cardiovascular diseases. The company develops, manufactures and markets
innovative products for vascular diseases extending life for over 75,000
patients worldwide annually.
Information: Ronald A.M. Horvers, CEO, +31-492-588-900 / info at bluemedical.com
Tags: Blue Medical Devices Bv, Helmond, Netherlands, November 16, The Netherlands