4 results
The objective is to test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprising two algorithmic components: a Safety Supervision Module (SSM) and an automated Range Correction Module (…
The objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprising two algorithmic components: a Safety Supervision Module (SSM) and an automated Range…
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…