Drug-Resistant High Blood Pressure Treatment and Therapy Options

Drug-resistant high blood pressure is a condition in which multiple drugs are prescribed and blood pressure remains high. In some cases, a non-pharmaceutical treatment option may be appropriate to consider. There are currently no FDA-approved devices for the treatment of hypertension, but carotid baroreflex therapy has shown promise with favorable, early clinical experience.

Carotid baroreflex therapies, such as the MobiusHD® device, have been designed to modulate the sympathetic nervous system and reduce blood pressure.

Baroreceptors are stretch-sensitive pressure sensors located along the carotid arteries in the neck. As a part of the body’s natural baroreflex, these receptors monitor the increased stretch of the arterial wall with pressure and send signals to the brain resulting in reduced sympathetic tone and blood pressure.

The unique, rectangular-shaped MobiusHD implant is a self-expanding, thin strut design that reshapes the carotid sinus following its catheter-delivered, endovascular implantation. This gentle implant-induced arterial stretch is intended to lower blood pressure by creating a sustainable amplification of the baroreflex while maintaining normal blood flow and pulsatility.

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EVBA: EndoVascular Baroreflex Amplification

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MobiusHD® System

The MobiusHD® System is the only hypertension treatment amplifying the natural baroreceptor response in the carotid sinus with a minimally invasive procedure.

CAUTION: investigational device. Limited by United States law to investigational use.

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AMPLIFY

Reshaping of carotid sinus amplifies baroreceptor signaling to the brain

REDUCE

Significant blood pressure reduction demonstrated in multiple clinical studies4

LONG LASTING

Durable safety and efficacy at two-years4

NON-SURGICAL

Minimally invasive access using endovascular techniques

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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.