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

The MobiusHD device is designed to amplify the body’s natural baroreflex mechanism, signaling the brain to restore cardiac autonomic adaption and balance.

The endovascular baroreflex amplification (EVBA) procedure includes the use of established percutaneous, catheter-based techniques providing a straightforward, one-time approach to symptomatic heart failure patients with reduced ejection fraction (HFrEF).

  • Self-expanding, rectangular nitinol implant
  • Unique endovascular device for baroreflex
  • Reshapes the carotid sinus without expansion
  • Retains pulsatility and increases carotid sinus stretch
  • Amplifies baroreceptor signals to the brain

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

Source: La Rovere and Christensen, Vascular Pharmacology, 2015

  • 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.

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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

Address:
30 Fairbanks, Suite 100
Irvine, CA 92618 USA

P: +1.949.942.1640
E: [email protected]