Embrella Embolic Deflector device highlighted during JIM 2010 meeting in Rome

Feb 19 2010

Embrella Cardiovascular™, Inc., a privately held company announced that the Embrella Embolic Deflector™ device was highlighted during a live case transmission last week at the Joint Interventional Meeting (JIM) in Rome, Italy. The Embrella Embolic Deflector™ device was used in a transcatheter aortic valve implantation (TAVI) procedure performed at Helios Klinikum Heart Center, Siegburg, Germany by Ulrich Gerckens, M.D., Chief of the Department of Cardiology/Angiology and Interventional Cardiologist Ralf Müller, M.D.

“Our clinical experience with the device has been extremely positive. With the first in man experience by Dr. John Webb last month and these clinical trial cases we have completed eight procedures with excellent results”

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 interventional procedures.

The JIM 2010 meeting was attended by cardiologists worldwide. Dr. Gregg Stone, Professor of Medicine at Columbia University Medical Center/New York-Presbyterian Hospital was the moderator of the session in which the Embrella Embolic Deflector™ device was used to provide cerebral protection during a TAVI procedure. In TAVI procedures there is a risk that embolic debris may become dislodged and travel to the brain during the passage of catheters around the aortic arch, with the inflation of a balloon across the stenotic and calcified aortic valve and during the placement of the prosthetic valve.

The procedure was transmitted from the cardiac catheterization lab in Siegburg, Germany. Dr. Ralf Müller commented, “We used the Embrella device in a TAVI procedure with the Medtronic CoreValve prosthesis. The Embrella remained in position without any adverse device interaction. The device was easy to position and to retrieve. During the procedure we also had transcranial Doppler (TCD) monitoring which did not show any showers of emboli during the procedure while the Embrella device was in place. Diffusion weighted MRI of the brain performed 3 hours after the procedure excluded cerebral embolism.”

Last week also marked the initiation of the Safety and Feasibility Trial with Dr. John Webb, Clinical Associate Professor, Department of Cardiology, St. Paul's Hospital/University of British Columbia, Vancouver, Canada as the Principal Investigator for the study. The first clinical trial cases have been enrolled in Germany by Dr. Ralf Müller in Siegburg and by Dr. Joachim Schofer, Professor of Cardiology from the University Hospital in Hamburg. The Embrella Embolic Deflector™ System has been used successfully in index procedures such as Balloon Aortic Valvuloplasty (BAV) and also TAVI procedures using both the Edwards Lifesciences and the Medtronic implants.

“Our clinical experience with the device has been extremely positive. With the first in man experience by Dr. John Webb last month and these clinical trial cases we have completed eight procedures with excellent results,” commented Carol Burns, Vice President Product and Business Development.

Jeffrey O’Donnell/CEO and Chairman said, “We are very encouraged by the device performance and the early TCD and post procedure diffusion weighted MRI data. We look forward to completing the clinical trial positioning the company one step closer toward European commercialization bringing this technology to more physicians and patients.”

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

SOURCE Embrella Cardiovascular, Inc.