REPRISE II EXTENSION
A prospective, single-arm, multi-centre study designed to evaluate the safety & performance of the Lotus Valve System for TAVI in symptomatic patients with severe calcific aortic stenosis considered high risk for surgical valve replacement.
- 16 sites
- Available valve sizes: 23mm & 27mm
- Follow-up at 7 days/discharge, 30 days, 3 & 6 months, annually 1-5 years