REPRISE II

A prospective, single-arm, multicentre study designed to evaluate safety and performance of the Lotus™ Valve System for symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

  • 14 sites
  • Available valve sizes: 23mm & 27mm
  • Follow-up at 7 days/discharge, 30 days, 3 & 6 months, annually 1-5 years