Clinical Trials

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.

Are you a Healthcare Professional outside of the U.S.?

 

The following page contains content about Vascular Dynamics products, which are only available for healthcare professionals outside of the United States. This content is NOT intended for U.S. audiences. Do you wish to continue?

No Yes

Caution: In the United States, the MobiusHD® system is limited by law to investigational use only.

You have Successfully Subscribed!

Are you a Patient outside of the U.S.?

 

The following page contains content about Vascular Dynamics products, which are only available for patients outside of the United States. This content is NOT intended for U.S. audiences. Do you wish to continue?

No Yes

You have Successfully Subscribed!

Are you a Healthcare Professional in the U.S.?

 

The following page contains content about Vascular Dynamics products, which are only available for healthcare professionals in the United States. This content is ONLY intended for U.S. audiences. Do you wish to continue?

No Yes

Caution: In the United States, the MobiusHD® system is limited by law to investigational use only.

You have Successfully Subscribed!

Are you a Patient in the U.S.?

 

The following page contains content about Vascular Dynamics products, which are not available for marketing in the United States. This content is ONLY intended for U.S. audiences. Do you wish to continue?

No Yes

You have Successfully Subscribed!

Are you a Patient outside of the U.S.?

 

The following page contains content about Vascular Dynamics products, which are only available for patients outside of the United States. This content is NOT intended for U.S. audiences. Do you wish to continue?

No Yes

You have Successfully Subscribed!

Are you a Patient in the U.S.?

 

The following page contains content about Vascular Dynamics products, which are not available for marketing in the United States. This content is ONLY intended for U.S. audiences. Do you wish to continue?

No Yes

You have Successfully Subscribed!

Subscribe To Our Newsletter

Join our mailing list to receive the latest news and updates from our team.

You have Successfully Subscribed!

MobiusHD®Procedure

You have Successfully Subscribed!