Embrella Cardiovascular, Inc. Receives European
CE Mark Approval for the Embrella Embolic
Deflector Device
May 19, 2010 03:37 PM Eastern Daylight Time
WAYNE, Pa.--(EON: Enhanced Online News)--Embrella Cardiovascular™, Inc., a medical device company,
announced its European notified body has granted CE Mark approval for the company’s Embrella Embolic
Deflector®, an aortic embolic protection device which acts as a protective shield to reduce the incidence of
embolization to the brain. This approval will allow the Company to begin marketing the device in European countries
and other countries around the world that recognize the CE Mark approval process.
The Embrella Embolic Deflector® will serve as an adjunctive device to be used in procedures such as the less
invasive Transcatheter Aortic Valve Implantation (TAVI) procedure. This technology is currently approved in
Europe for high risk patients with severe aortic stenosis. Frequently the aorta contains atheromatous plaque and the
valve can be densely calcified. During TAVI, wires, catheters and balloons pass over the aortic arch where they may
dislodge debris and calcific particles. Unless deflected from the arteries leading to the head, such debris may
embolize to the brain and cause stroke.
Commenting on this CE Mark approval, Embrella Chairman and CEO, Jeffrey O’Donnell said, “The TAVI market
is expected to grow dramatically over the next few years. According to analysts, the global TAVI market is
expected to grow from over $200 million in TAVI sales in 2009 to over $1.7 billion in 2015. This approval enables
us to begin to commercialize the Embrella Embolic Deflector® in European markets. We believe that cerebral
protection will be used as a standard of care in all Transcatheter Aortic Valve Implantation procedures.”
“We are pleased that we continue to receive positive feedback from physicians in Europe and Canada. They not
only find the Embrella Embolic Deflector® to be intuitive and easy to use, but it also performs effectively