4 results
The objective of the study is to assess the safety, tolerability and efficacy of PRO044.
The primary objective of the study is to provide evidence that the use of a sealing surgical patch applied to the surgical field following parotidectomy is non-inferior in efficacy to the common practice of CSD insertion by wound closure, measured…
The primary efficacy variable is if the TachoSil application was feasible. A feasible application implies that the entire TachoSil adhere, TachoSil covers at least 1 cm beyond the margins of the anastomosis line and if more TachoSil sponges are used…
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…