Reshaping Neuromodulation™ with the MobiusHD® System
An endovascular device-based approach to help patients suffering from autonomic imbalance.
CAUTION: Investigational device. Limited by United States law to investigational use.
Baroreflex Neuromodulation
Device-Based Treatment for Autonomic Imbalance
Chronically elevated sympathetic nervous system activity is an underlying pathophysiological mechanism of a number of disease conditions.
A promising investigational device treatment option involves neuromodulation of the carotid baroreflex which is essential to the body’s natural regulation of the autonomic nervous system, including the sympathetic and parasympathetic systems.
The baroreflex relies on specialized stretch-sensitive baroreceptors located along the carotid arteries in the neck. Baroreceptors monitor increased arterial wall stretch and send signals to the brain resulting in reduced sympathetic tone and increased parasympathetic activity.
Baroreceptors and Baroreflex Mechanism
- Powerful centralized neuromodulation
- Arterial baroreceptors are mechanoreceptors
- Located in aortic arch and carotid sinus
- Respond to stretch and wall tension
- Important afferent input to the brain (CNS)
- Increased signaling from baroreceptors to CNS
- Centralized correction of ANS imbalance
- Inhibition of sympathetic activity to maintain homeostasis
EVBA: EndoVascular Baroreflex Amplification
Reshaping Neuromodulation With the MobiusHD Device
MobiusHD System
The MobiusHD System is the only device treatment amplifying the natural baroreceptor response in the carotid sinus with an endovascular procedure.
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
Clinical Evidence
Positive Preliminary Findings
- Three month results for the first thirteen patients
- All patients were successfully implanted with the MobiusHD device
- No serious adverse events
- All implants were placed in pre-procedurally determined locations
- All thirteen patients showed improved quality of life and 6MHW and reductions 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
- 6MHW distance of 150 to 400m
- NT-proBNP > 400 pg/ml
The EVBA procedure has been evaluated in clinical studies targeting resistant hypertension. Clinical evidence to date includes data from 89 patients. The initial results of a European cohort of 30 patients were reported by Spiering et al (The Lancet, 2017).
Additional clinical evidence is also available including three year follow-up data showing sustained, beneficial decreases in blood pressure.
Experience with MobiusHD as Treatment for Uncontrolled Blood Pressure
Patient
Atlanta, Georgia
Chandan Devireddy, MD
Emory University
Interventional Cardiologist
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