Embrella Embolic Deflector Used for First Clinical Case

January 4, 2010—Embrella Cardiovascular, Inc. (Wayne, PA) announced the completion of the first clinical case using the Embrella Embolic Deflector device. John Webb, MD, performed the procedure at St. Paul's Hospital in Vancouver, British Columbia.

According to the company, the Embrella Embolic Deflector is an aortic embolic protection device that acts to reduce the incidence of embolization to the brain; the porous membrane deflects the emboli. 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 that is the typical access site for index procedures. Embrella advised that the device is not available for clinical use in the United States.

The Embrella device was used in a 91-year-old patient undergoing a balloon aortic valvuloplasty procedure, in which 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. In this case, 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 procedure, the company stated.

“We were pleased to see how well the device tracked into the aorta and how easily it was positioned,” commented Dr. Webb. “It covered the orifice of the brachiocephalic, left common carotid, and left subclavian arteries. There was no interaction with the device as we advanced several wires and catheters past the Embrella device en route to the aortic valve.”