RESPOND POST MARKET STUDY

Professor Jochen Wöhrle (University of Ulm, Germany) compares the results of the Respond study with his own experience of more than 200 Lotus valve procedures.  In both cases, less than 10% of patients had mild regurgitation.

A prospective, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Valve used in routine clinical practice.

  • 1014 patients enrolled: 41 centers in Europe, Asia-Pacific, and Latin America  
  • Available valve sizes: 23mm, 25mm, & 27mm  
  • Primary Endpoint: All-cause mortality at 30 days and 1 year post-implantation  
  • Key Secondary Endpoint: Grade of paravalvular aortic valve regurgitation pre-discharge
  • Clinical endpoints at 30 days: Defined according to VARC 2 guidelines

       

RESPOND POST MARKET STUDY RESULTS
1014 Patients at 30 days*