High Blood Pressure Study

Are you, like millions of others, having difficulty lowering your blood pressure with medications? As you probably know, when high blood pressure can’t be controlled, it increases your risk of serious health problems such as heart disease, stroke, and kidney failure.

If you’re struggling to lower your blood pressure, and are already on medications, you may be a candidate for the CALM-2 Clinical Study. The study is evaluating an investigational device designed to lower blood pressure through a minimally-invasive procedure.

About the CALM-2 Study

What is the MobiusHD^® device?

The MobiusHD is an investigational implant designed to lower blood pressure through a minimally-invasive procedure. A single, small incision is made in the upper thigh. A small flexible catheter is inserted, and then advanced to the carotid artery in the neck. The catheter is used to deliver a small implant that is similar to a stent (the MobiusHD® device) in the carotid artery, and the catheter is removed. Once placed, the MobiusHD implant is designed to increase signals from our body’s baroreceptors, specialized nerves that trigger the body’s natural process to reduce blood pressure.

What is the CALM-2 Clinical Study?

Right now, doctors at select medical centers in the US and Europe are conducting a new research study to evaluate the MobiusHD implant and its ability to lower blood pressure (the CALM-2 Clinical Study). If you’ve been unable to lower your blood pressure and are already on medications, the CALM-2 Study may be right for you.

Frequent Questions

1. What is the purpose of a clinical study?

Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by local regulatory authorities. These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

2. Are there any costs involved in the CALM-2 Clinical Study?

If you choose to join the study, you will receive all study-related care at no cost. This includes the MobiusHD implant and procedure, as well as any follow-up visits to your study doctor’s office required for the study. You may also be reimbursed for your travel and expenses to attend study visits.

3. How long does the study last?

If you join the CALM-2 Clinical Study, your participation will last at least 5 years. Following your procedure, you will return to your study doctor’s office for 5 follow-up visits over the first year, and will then return for 2 visits per year over the next four years. These visits are an important part of the study, as they allow your study doctor to closely monitor your individual results and experiences.

4. What if I join the study and decide I do not want to participate anymore?

As with all clinical studies, your participation is completely voluntary, and you may choose to leave the study at any time.

5. Who is sponsoring the study?

The study is being sponsored by Vascular Dynamics, Inc. (www.vasculardynamics.com), a medical device company headquartered in Mountain View, CA

6. I am interested in hearing more. What is the next step?

To see if you might be eligible for the CALM-2 Clinical Study, and to be referred to a study center in your area, the next step is taking the pre-screening questionnaire. Please click here to get started.

See If You Are Eligible

To see if you might be eligible for the CALM-2 Clinical Study, and to get connected with your local study center to learn more, please take the questionnaire below. If you prefer to take the questionnaire over the phone, please call 1-855-578-8390.