Andreas Baumbach1,2,3; Darren Mylotte4, MD; David Hildick-Smith5, MD; Simon Kennon2, MD; Michael Jonas6, MD; Krzysztof Bartus7, MD; Jaroslaw Trebacz7, MD; Rotem Halevi8, PhD; Yael Kislev8, PhD; Lena Plotnikov8, PhD; Peter Andreka9, MD
1. Center for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom; 2. Barts Heart Centre, St. Bartholomew’s Hospital, London, United Kingdom; 3. Yale University School of Medicine, New Haven, CT, USA; 4. University Hospital, SAOLTA Healthcare Group, and the National University of Ireland, Galway, Ireland; 5. Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United Kingdom; 6. Kaplan Medical Center, Rehovot, Israel; 7. Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland; 8. Pi-Cardia, Rehovot Science Park, Rehovot, Israel; 9. Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary
Senile calcific aortic stenosis (AS) is a multifactorial degenerative disease which results in calcification of the aortic valve leaflets. A bridging pattern of calcium involving both the centre and bases of the leaflets is typical and causes progressive restriction of valve opening, yielding the clinical syndrome of symptomatic AS. The Leaflex™ device (Pi-Cardia, Rehovot, Israel) is designed to score calcium deposits on the aortic surface of calcified aortic valve leaflets. The scoring lines aim to segment restrictive deposits and thereby increase mobility, reducing the severity of AS without implantation of a bioprosthetic valve. The device has undergone ...