CALM Clinical Studies
The CALM (“Controlling And Lowering Blood Pressure With The MobiusHD®”) clinical studies are evaluating the safety and efficacy of the MobiusHD® device as a treatment for resistant hypertension.
CALM-FIM (First-In-Man): A prospective multicenter single-arm safety study.
Fully enrolled in the EU. [clinicaltrials.gov]
Currently enrolling in the US. [clinicaltrials.gov]
Data from this trial will be presented at upcoming medical conferences and published.
CALM-DIEM: A single-arm, safety, efficacy post-market study.
In Europe the study is enrolling 200 patients. Trial is ongoing [clinicaltrials.gov]
CALM-START: A multicenter, prospective, randomized, blinded, sham-controlled study
In Europe the study is enrolling 110 patients. [clinicaltrials.gov]
CALM-II:A multicenter, prospective, blinded, randomized, sham-controlled study.
A FDA IDE pivotal study. Worldwide planned enrollment is 300 patients.
The CALM-II trial will be initiated in 2017.