Embrella Cardiovascular has been granted European CE mark approval for its Embolic Deflector, an aortic embolic protection device which acts as a protective shield to reduce the incidence of embolization to the brain.
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. The 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.
Jeffrey O’Donnell, chairman and CEO of Embrella, 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 $200m in TAVI sales in 2009 to over $1.7bn 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.”
Carol Burns, vice president of product and business development, said: “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.”