4 results
To measure serum insulin and glucose profiles after bolus insulin administration by a patch-pump versus a catheter based pump, reproducibility of these insulin profiles and the effect of catheter wear-time on these profiles in patients with type 1…
The primary objective of the study is to evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs in the 3 months following implantation. Secondary objectives are related to safety and efficacy:• To…
The objective of this study is to investigate whether an interatrial shunt device is superior to sham procedure in prevention of: (1) incidence of and time to cardiovascular mortality through 12-24 months; (2) incidence of and time to heart…
The purpose of the INTIBIA pivotal study is to demonstrate the safety and effectiveness of the INTIBIA System in the intended population through 24 months of follow-up. Data at 12-months will be used to support regulatory approval.The objective of…