3 results
To evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve…
To establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are not preferred/appropriate due to…
Objectives of Part A, B and C are the following: Part A: determination of the optimal mass dose of S095012 to inject with 89Zr-S095012 and optimal time point for PET scans for appropriate visualisation of 89Zr-S095012 through PET imaging. Part B…