MobiusHD Device for High Blood Pressure

(CALM-2 Trial)

This trial tests a new device called the MobiusHD to determine if it can safely and effectively lower high blood pressure. The study compares two groups: one receives the real MobiusHD device, while the other undergoes a sham (fake) procedure. It targets individuals who have struggled with high blood pressure (145-200 mmHg) for at least 8 weeks, despite taking up to 5 different blood pressure medications. Participants will help researchers assess whether this new method works better than relying solely on medication. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research in blood pressure management.

The trial requires you to continue taking your current blood pressure medications, specifically a combination of an ACE inhibitor or angiotensin receptor blocker, a calcium channel blocker, and a diuretic.

Research has shown that the MobiusHD device is generally safe for people with high blood pressure. One study found that it lowered blood pressure over three years and was usually well-tolerated by patients. Another study noted improvements in quality of life and exercise ability, with no major safety issues. However, more detailed studies are needed to fully understand its long-term safety and effectiveness.¹²³⁴⁵

Researchers are excited about the MobiusHD device because it offers a novel approach to treating high blood pressure, unlike standard treatments such as medications that target blood vessel constriction or fluid retention. The MobiusHD device is implanted to work on the carotid artery, using a new mechanism that potentially recalibrates the body's natural blood pressure regulation system. This method could provide a more sustained and effective way to manage hypertension, especially for patients who don't respond well to conventional medication. Additionally, the implant approach might reduce the need for multiple daily medications, simplifying treatment for patients.

In this trial, participants will receive either the MobiusHD device or undergo a sham implantation. Studies have shown that the MobiusHD device can lower blood pressure in people with resistant hypertension, which is high blood pressure that doesn't respond well to treatment. One study found that patients using the MobiusHD device experienced a significant drop in blood pressure over three years, and the device proved to be safe. The MobiusHD enhances the body's natural ability to control blood pressure by calming the part of the nervous system that manages stress. This device is placed in the carotid arteries, which are important blood vessels in the neck. Overall, research suggests that the MobiusHD could be a promising option for managing high blood pressure.¹³⁵⁶⁷