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

Source: La Rovere and Christensen, Vascular Pharmacology, 2015

  • 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

The catheter-delivered MobiusHD device is a four-sided implant that reshapes the carotid sinus following its endovascular implantation.  The implant-induced arterial stretch is intended to improve functional outcomes for heart failure patients by creating a sustainable amplification of the baroreflex while maintaining normal blood flow and pulsatility.

  • Self-expanding, rectangular nitinol implant
  • Reshapes the carotid artery without expansion
  • Retains pulsatility
  • Increases carotid artery strain/stretch
  • Amplifies baroreceptor signals to CNS

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

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)

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.

Read the article in The Lancet.

Experience with MobiusHD as Treatment for Uncontrolled Blood Pressure

Patient
Atlanta, Georgia

Chandan Devireddy, MD
Emory University
Interventional Cardiologist

Clinical Evidence

A Feasibility Study Exploring the Effect of the MobiusHD®
in Patients with Heart Failure

Study Objective

  • Evaluate cardiac performance and functional status in heart failure (HFrEF) patients implanted with the MobiusHD® implant

Study Design

  • Prospective, open-label clinical trial
  • Subjects to be seen at following intervals: 1 week, 1, 3, 6, 12, 18, and 24 months

Key Eligibility Criteria

  • Plaque-free carotid artery
  • Stable Guideline Directed Medical Therapy (GDMT)
  • LVEF < 40%
  • NYHA Class III
  • 6MHW distance of 150 to 400m
  • NT-proBNP > 400 pg/ml

www.ClinicalTrials.gov Identifier: NCT04590001

The EVBA procedure has been evaluated in clinical studies targeting resistant hypertension. Clinical evidence to date includes 89 patients, including the results of a European cohort of 30 patients which have been 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.

READ THE ARTICLE ON THE LANCET.

Patient and Professional Experience with MobiusHD as Treatment for Uncontrolled Blood Pressure


MobiusHD® Hypertensive Patient
Atlanta, Georgia


Chandan Devireddy, MD
Emory University
Interventional Cardiologist

The EVBA procedure has been evaluated in clinical studies targeting resistant hypertension. Clinical evidence to date includes 89 patients, including the results of a European cohort of 30 patients which have been 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.

READ THE ARTICLE ON THE LANCET.

Patient and Professional Experience with the Hypertensive Condition

MobiusHD® Hypertensive Patient
Atlanta, Georgia

Chandan Devireddy, MD
Emory University
Interventional Cardiologist

A Feasibility Study Exploring The Effect Of The
MobiusHD® In Patients With Heart Failure

Study Objective
Evaluate cardiac performance and functional status in heart failure patients implanted with the MobiusHD® implant

Study Design
Prospective, open-label clinical trial to evaluate HFrEF patients

Subjects to be seen at following intervals: 1 week, 1, 3, 6, 12, 18, and 24 months

Key Eligibility Criteria

  • Plaque-free carotid artery
  • Stable Guideline Directed Medical Therapy (GDMT)
  • LVEF < 40%
  • NYHA Class III
  • 6MHW distance of 150 to 400m
  • NT-proBNP > 400 pg/ml

www.ClinicalTrials.gov Identifier: NCT04590001

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.

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Management

Ed Roschak

President & CEO

Martin Rothman

Chief Medical Officer

John McIntyre

Vice President, Regulatory and Quality Assurance

Barbara Niksch

Vice President, Clinical Affairs

Board of Directors

Michael Henson

Chairman

Ilan Neugarten

Ben Tsai

Dr. Thomas Thaler

Gary Burbach

Stan Rabinovich

Press Releases

Contact

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Irvine, CA 92618 USA

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