Healthcare Industry News:  Embrella Cardiovascular 

Devices Interventional Regulatory

 News Release - May 19, 2010

Embrella Cardiovascular, Inc. Receives European CE Mark Approval for the Embrella Embolic Deflector Device

WAYNE, Pa.--(HSMN NewsFeed)--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 without affecting the index procedure,” added Carol Burns, Vice President, Product and Business Development.

About Embrella Cardiovascular

Embrella Cardiovascular™, Inc., is dedicated to creating a new standard-of-care for cerebral embolic protection during cardiovascular procedures. Embrella's Embolic Deflector®, an aortic embolic protection device which acts as a protective shield to reduce the incidence of embolization to the brain, has been granted CE Mark approval. Embrella is a private, venture backed medical device company whose investors include BioStar Ventures, MedFocus Fund, Hatteras Venture Partners and Edwards Lifesciences Corporation.

Source: Embrella Cardiovascular

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