LOTUS aortic valve studied in REPRISE I,II,IIEXT.,III,RESPOND and REPRISE JAPAN. LOTUS Edge aortic valve studied in REPRISE EDGE.
Initial data of the next generation LOTUS Edge valve system shows low event rates
30-day results from the LOTUS Edge Feasibility Trial suggest that the advantages of the first-generation LOTUS Valve System are conserved with the next generation LOTUS Edge Valve System with 100% technical success, 95% none or trace PVL, and low VARC events. The PPM rate of 9.5% provides an initial indication that the Depth Guard feature, which is intended to enable predictable placement, early anchoring during deployment, minimal depth of valve frame and a reduced interaction with the LVOT, may effectively reduce the PPM rate. Due to the limited size of cohort studied in the LOTUS Edge Feasibility Trial, further investigation of LOTUS Edge is ongoing.
Poster presented by D. Walters, MD at ACC 2017