Aortic Valve System
Advancing Clinical Science
Boston Scientific has a very comprehensive TAVR clinical program, including multiple studies that follow more than 2,500 patients.
Through this clinical program, we are focused on demonstrating that the LOTUS valve platform offers outstanding clinical data. Watch now to see our latest clinical data updates, including a downward trend in PPM and low PVL rates.
Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.
LOTUS Valve Platform Clinical Program
30 Day Results from the LOTUS Edge Feasibility Trial Presented at ACC 2017
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