Reshaping Neuromodulation™ with the MobiusHD® System
An endovascular device-based approach to help patients suffering from heart failure.
CAUTION: Investigational device. Limited by United States law to investigational use.
Reshaping Neuromodulation With the MobiusHD Device
EVBA Procedure
The percutaneous EVBA procedure uses well-established carotid access techniques and allows for precise placement of the MobiusHD implant in the target location.
- Pre-procedure imaging:
- Confirm carotid artery suitability
- Define implant location
- Endovascular procedure using standard techniques
- Angiographic confirmation
- MobiusHD implant deployment
Positive Initial HFrEF Findings
This clinical trial is intended to evaluate the safety and effectiveness of the MobiusHD device in patients suffering from heart failure with reduced ejection fraction. (www.ClinicalTrials.gov Identifier: NCT04590001)
Symptomatic Improvement (n=21) 
Confirmatory Evidence (n=21)
- All patients were successfully implanted with the MobiusHD device in pre-procedurally determined locations
- Initial evidence through 12 months FU shows favorable effects on cardiac function and clinical profile
- Improved quality of life (KCCQ OSS)
- Increased exercise tolerance 6MWD
- Improved NYHA class
- Improved LVEF
- Reduction in NT-proBNP
A Feasibility Study Exploring the Effect of the
MobiusHD Device in Patients with Heart Failure
Study Design
- Prospective, open-label clinical trial
- Subjects to be seen at the following intervals: 1 week, 1, 3, 6, 12, 18, and 24 months
Key Eligibility Criteria
- Suitable carotid artery anatomy
- Stable Guideline Directed Medical Therapy (GDMT)
- LVEF ≤ 40%
- NYHA Class III
- 6MWD distance of 150 to 400m
- NT-proBNP ≥ 400 pg/mL
Baroreflex Neuromodulation
- The autonomic nervous system (ANS) is integral to cardiovascular system function
- Heart failure (HF) pathophysiology is mediated by autonomic dysfunction with a sustained imbalance of increased sympathetic activity and decreased parasympathetic activity
- The baroreflex, a key powerful regulator of cardiovascular homeostasis, is a critical consideration in heart failure
- Baroreflex neuromodulation has a role as an HF therapy
Baroreceptors and Baroreflex Mechanism
- The baroreflex provides a powerful centralized neuromodulation to ANS
- Maintains normal homeostasis: Inhibition of sympathetic activity and augmentation of parasympathetic drive
- Therapeutic target to restore natural physiological autonomic adaptation and balance
- Carotid baroreceptors are mechanoreceptors
- Located in carotid sinus (more sensitive than the aortic arch receptors)
- Activated by arterial wall stretch, not pressure
- Triggers increased signaling to the brain
- Sustained baroreceptor activation response to pulsatile carotid sinus stretch
About Vascular Dynamics
Vascular Dynamics is developing an innovative, endovascular platform technology to offer compelling treatment options for patients at risk of life-threatening conditions underserved by conventional treatments.
The company’s MobiusHD technology features the first endovascular device to use the body’s natural baroreflex mechanism to modulate the autonomic nervous system. The endovascular baroreflex amplification (EVBA) approach targets both afferent and efferent neural pathways to realize a reduction in sympathetic tone and an increase in parasympathetic activity.
Clinical evaluations of this unique baroreflex modulation therapy for heart failure and high-risk hypertensive patients are in progress.
Press Releases
Vascular Dynamics' Early Clinical Results for Novel Heart Failure Treatment Show Promise as Stan Rabinovich is Named to Board of Directors
May 18, 2021
Positive Preliminary Clinical Trial Results Reported for Vascular Dynamics’ Novel Heart Failure Treatment Technology
Feb 9, 2021
Vascular Dynamics Names Prof. Martin Rothman Chief Medical Officer
Jan 23, 2019
Vascular Dynamics Announces Initial Enrollment in Rigorously Designed Hypertension Trial
Sept 4, 2018
Vascular Dynamics Appoints Ed Roschak CEO
Dec 4, 2017
Vascular Dynamics Interim Data on MobiusHD Presented at TCT Conference Shows Significant Reductions in Ambulatory Systolic Blood Pressure At Six Months
Oct 30, 2017
Data Published in The Lancet Shows Positive Results at Primary Endpoint in the Treatment of Resistant Hypertension with MobiusHD Device
Sep 1, 2017