Healthcare Industry News:  Embrella Cardiovascular 

Devices Interventional

 News Release - January 5, 2010

Embrella Cardiovascular, Inc. Completes Successful First Clinical Experience

WAYNE, Pa.--(HSMN NewsFeed)--Embrella Cardiovascular, Inc., a privately held company announced that it has completed its first clinical case using the Embrella Embolic Deflector™. The company has developed a novel technology designed to make less invasive cardiovascular procedures safer for patients by decreasing the risk of emboli traveling to the brain. The procedure was performed at St. Paul’s Hospital in Vancouver, Canada by Dr. John Webb, Director of Cardiac Catheterization and Interventional Cardiology.

The Embrella Embolic Deflector™ is an aortic embolic protection device which acts as a protective shield to reduce the incidence of embolization to the brain. The porous membrane deflects these dangerous emboli which can cause neurological complications. It is an adjunctive device positioned at the beginning of an index procedure and removed at the completion of the procedure. The device is inserted through the right radial or right brachial artery, away from the femoral artery which is the typical access site for index procedures.

The Embrella Embolic Deflector™ device was used in a 91 year old patient undergoing a Balloon Aortic Valvuloplasty (BAV) procedure. During BAV procedures there is a risk that atheromatous plaque may be dislodged and travel to the brain during the passage of catheters around the aortic arch or during the subsequent balloon dilation of the stenotic and calcified aortic valve. “We are thrilled with the successful outcome of our first clinical case,” said Jeffrey O’Donnell, CEO, Embrella Cardiovascular, Inc. “A Balloon Aortic Valvuloplasty is just one of the many cardiovascular procedures that could be aided by an aortic embolic protection device. Throughout this next decade other structural heart procedures such as Transcatheter Aortic Valve Implantation (TAVI), will undoubtedly advance. We believe the Embrella device will play a role in the acceptance of these procedures by making them safer for patients with less cost associated with possible morbidity from neurological complications. We also see utility for the technology in cardiac surgery procedures, ” added O’Donnell.

The device was inserted through the right radial artery, and passed through the brachiocephalic artery and positioned along the greater curvature of the aorta. The device remained in position during the entire BAV procedure. “We were pleased to see how well the device tracked into the aorta and how easily it was positioned. It covered the orifice of the brachiocephalic, left common carotid and the left subclavian arteries. There was no interaction with the device as we advanced several wires and catheters past the Embrella device enroute to the aortic valve,“ commented Dr. Webb.

“This is a significant milestone for Embrella Cardiovascular. The engineering team worked diligently focusing on design simplicity and ease of use. This marks the first clinical case using an embolic protection device positioned in the aorta specifically designed for interventional procedures. Our next stage of development is the Feasibility Trial which will be initiated later this month at clinical sites in both Canada and Germany,” stated Carol Burns, Vice President, Product and Business Development.

The Embrella Embolic Deflector™ device is not available for clinical use in the United States.

About Embrella Cardiovascular

Embrella Cardiovascular,™ Inc. is dedicated to creating a new standard-of-care for cerebral embolic protection during cardiovascular procedures. Embrella Cardiovascular,™ Inc. believes that this technology will be successfully utilized as a safe, efficacious and cost effective method to prevent dangerous clot or debris from embolizing into the carotid arteries during cardiovascular procedures.

Source: Embrella Cardiovascular

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