Device profile of the MobiusHD EVBA system for the treatment of resistant hypertension: overview of its mechanism of action, safety and efficacy

ABSTRACT

Introduction

Early promising results of renal nerve denervation awakened interest in developing medical device alternatives for patients with resistant hypertension. The subsequent sham-controlled renal nerve denervation randomized trials were disappointing leading researchers and innovators to explore alternative device and trial designs to address this significant unmet need. We describe the innovation process leading to the first endovascular carotid baroreflex amplification device currently undergoing clinical trials in the United States and Europe.

Areas covered

We provide a brief overview of carotid baroreceptor physiology and then couple this knowledge with the fundamental principles of strain pattern changes that led to the proposed innovation. The mechanism of blood pressure reduction via enhancing innate physiologic carotid sinus baroreceptor signaling through changes in pulsatile focal carotid bulb strain is described alongside preclinical testing and early clinical results.

Expert opinion

The collective data to date suggest endovascular carotid baroreflex amplification may be an innovative alternative for resistant hypertension patients. However, well-controlled studies will be needed to assess efficacy, safety, durability, and risk: benefit of this permanent intravascular carotid implant.

Subject codes

high blood pressure, hypertension, treatment, physiology

KEYWORDS:

• Resistant Hypertension
• carotid baroreceptor
• baroreflex
• barostimulation
• device
• MobiusHD
• endovascular carotid baroreflex amplification

Article highlights

1. Carotid baroreceptors play an important role in maintaining hemodynamic balance and are a potential therapeutic device target for blood pressure reduction.

2. The carotid baroreceptors are activated by pressure change induced carotid bulb stretch rather than pressure alone and pulsatile stretch is needed for sustained blood pressure response.

3. Sustained blood pressure reduction has been achieved with implantable electrical carotid baroreceptors stimulation devices.

4. The mechanism of action for blood pressure reduction with Endovascular Carotid Baroreflex Amplification is not intuitive and involves changes in pulsatile focal carotid bulb strain induced by implant induced geometric vessel changes.

5. Preclinical and early Endovascular Carotid Baroreflex Amplification clinical results in patients with resistant hypertension are promising but additional data is needed to confirm long-term safety and efficacy.

Declaration of interest

GS: Speaker or other honoraria from Cook, Terumo, QOOL Therapeutics and Orchestra Biomed; Consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme; Equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, Valfix.

MB: Past consultant for vascular dynamics and presently consultant for W.L. Gore and Associates

CC: Past consultant for Vascular Dynamics

WS: Consultant for Vascular Dynamics

Declaration of interest

G Stone has received speaker or other honoraria from Cook, Terumo, QOOL Therapeutics and Orchestra Biomed; been a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, Valfix. M Bates is a past consultant for vascular dynamics and presently consultant for W.L. Gore and Associates. C Chen is a past consultant for Vascular Dynamics. W Spiering is a consultant for Vascular Dynamics.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This invited review was not sponsored by Vascular Dynamics Inc. and the authors were not directly paid for their contribution to this manuscript. However, all four authors were remotely (MCB and C-Y C) or are presently (GWS and WS) consultants for Vascular Dynamics, inc and some of the company’s sponsored research was used to construct the paper. Additionally, research done by one of the authors (MCB) is supported, in part, by the National Institutes of Health under Award Number 5U54GM104942-04. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.