Protembis GmbH, a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo® Cerebral Protection System. The ProtEmbo® System is an intra- aortic filter device that deflects embolic material away from the brain during transcatheter aortic valve replacement (TAVR). The device is a low profile system which is delivered through the left radial artery, an ideal access site enabling physicians to avoid interference with TAVR equipment, typically delivered through the femoral artery.
Nikos Werner, M.D., Professor of Medicine, Head of Cardiology at the Heart Center Trier, Germany, and Principal Investigator in Germany commented: “Embolic protection in TAVR procedures has been shown to be effective in reducing the ischemic burden in the brain, but physicians look forward to next generation devices that are easy to use, cover all three potential access arteries to the brain, and can be simply and rapidly deployed without interfering with the TAVR procedure. The initial procedures with the ProtEmbo® System are very promising in this regard and show that the device can fulfil all of these criteria, with even smaller pores allowing effective protection of the brain.”
This new generation of the ProtEmbo® System has an improved frame shape and a dedicated ergonomic handle to facilitate push-pull and torque of the device during deployment and retrieval. The filter, using 60 micron pores, is self-positioning in the aortic arch across all three major cerebral arteries, maintaining blood flow to the brain. The filter surface is heparin-coated to avoid clot formation.