3 results
Approved WMOCompleted
The OneShotTM System procedure is designed to provide the anatomical and physiologic benefits of catheter-based RDN at lesser risk to the subject, due to a reduction of complexity of the procedure and design improvements intended to enhance…
Approved WMOCompleted
The primary objective of this clinical investigation is to investigate the effect of the Provox Luna system on compliance of HME use. Compliant use is defined as daily use of an HME for at least 20 hours per day 86% (=24/28; each study period is 4…
Not approvedWill not start
The objective of this clinical investigation is to evaluate the clinical performance of Provox Luna in comparison to the usual care of the patient.