The Challenge of Drug-Resistant Hypertension

Half of all people taking prescription medications are still unable to keep their high blood pressure under control. About one in ten treated patients will have drug-resistant hypertension, defined by recently updated guidelines as the failure to reach a targeted blood pressure goal of less than 130/80 mmHg despite adhering to full doses of at least three anti-hypertensive medications. Drug-resistant hypertension results in dramatically increased, often life-threatening, risks of kidney disease, heart disease, and stroke.

Treatments for Drug-Resistant High Blood Pressure

Vascular Dynamics Inc. (VDI) is sponsoring the FDA-approved CALM-2 study of the endovascular baroreceptor amplification (EVBA) procedure using the investigational MobiusHD® device as a treatment for drug-resistant hypertension.

The EVBA procedure includes the use of the first minimally invasive technology that utilizes the body’s natural blood pressure control system, the baroreceptor mechanism or baroreflex, to address resistant hypertension. Baroreceptors are specialized nerves located in the carotid artery which detect changes in stretch of the arterial wall and signal the brain to control blood pressure. The MobiusHD device is a thin, self-expanding rectangular implant that reshapes the carotid sinus following its endovascular implantation. It is intended to amplify the baroreflex while maintaining normal blood flow and pulsatility of the artery.

Learn more about Therapy options
Learn more about the MobiusHD System investigational study

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Hypertension impacts 1 billion people worldwide and the clinical consequences are devastating1,2,3

When your blood pressure is high:

 
You are 4x more likely to die from a stroke
You are 3x more likely to die from heart disease
of people who have a first heart attack...
of people who have a first stroke...
of people with chronic heart failure...
 

Have high blood pressure

 
Only about half
of people with high blood pressure have their condition under control
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Clinical Trials

  • CALM-FIM

    CALM-FIM was a prospective, first-in-human, open-label study done at six sites in Europe. The MobiusHD system was studied in patients with an office systolic blood pressure ≥160 mmHg despite taking at least three antihypertensive agents, including a diuretic.

    Results showed a significant decrease in mean ambulatory blood pressure in 73% of patients at 24 hours and blood pressure reduction of 21/12 mmHg at six months, as compared to baseline4.

      Publication can be found here.

  • CALM-2

    The MobiusHD System is being studied in the CALM-2 clinical trial in patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy.

    The CALM-2 clinical trial is currently enrolling at select medical centers in the United States and Europe. For more information visit www.calm2study.com

    See if you qualify

©2018 Vascular Dynamics, Inc. All rights reserved.  |  Reshaping Hypertension is a trademark of Vascular Dynamics, Inc. MobiusHD is a registered trademark of Vascular Dynamics, Inc.