The Embrella Embolic Deflector, which was used in a transcatheter aortic valve implantation (TAVI) procedure performed at Helios Klinikum Heart Center in Germany, is an aortic embolic protection device that 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 Embrella Embolic Deflector System has been used in index procedures such as Balloon Aortic Valvuloplasty (BAV) and also TAVI procedures using both the Edwards Lifesciences and the Medtronic implants.

Carol Burns, vice president of Product and Business Development, said: “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.”

Jeffrey Donnell, CEO and chairman, said: “We are 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.”

Ralf Muller, interventional cardiologist, said: “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.”