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BAROSTIM NEO & Your Patients

BAROSTIM NEO

A small device with a powerful effect

BAROSTIM THERAPY™ is effectively administered through BAROSTIM NEO™, a minimally-invasive, long-lasting device. 1 

Extravascular, implantable system:

BAROSTIM NEO Carotid Sinus Lead Implantable Pulse Generator (IPG) Device:

Carotid Sinus Lead: 
A 2mm electrode is sutured to the carotid artery and connected to the IPG, electrically activating the baroreceptors. 

Implantable Pulse Generator (IPG) Device: 
A highly powerful, implantable pulse generator is inserted under the collar bone, stimulating approximately 40 times more frequently than a pacemaker.

Wireless Programmer System:
The unique on/off capability can promote the observation of the differences that BAROSTIM THERAPY™ makes in blood pressure and other Hemodynamic parameters.

For more information, please view the  Technical Specification Sheet

References:
1. BAROSTIM NEO system™ reference guide. Available here – Last accessed March 2016. 

Implantation Procedure

How to place BAROSTIM NEO™

The placement of the BAROSTIM NEO™ System, the device that delivers BAROSTIM THERAPY™, requires a minimally-invasive procedure under general anaesthesia.

1. Preparation

  • Ensure all materials required for the procedure are available

2. Lead Placement

  • Make an incision in the neck
  • Expose the carotid artery
  • Connect the lead to the IPG
  • Map the lead
  • Suture the lead
  • Disconnect the lead from the IPG

3. IPG Placement

  • Create the pocket
  • Tunnel the lead
  • Create the strain relief loop
  • Connect the lead to the IPG

4. Closure

  • Secure the IPG
  • Close the incisions

Customisation

How to individualise BAROSTIM THERAPY™

Recipients of BAROSTIM THERAPY™ will need to return for regular follow-up visits after the implantation procedure.

Patient Management
Personalised therapy that puts you in control. 1,2

Wireless programmer system
Allows for non-intrusive, fully customisable patient follow-up. 1

Deactivating & Reactivating the BAROSTIM NEO™ system
If needed, temporary deactivation can be achieved through the use of a medical magnet. Reactivation occurs automatically upon removal. 2

References:
1. BAROSTIM NEO system™ reference guide. Available here – Last accessed March 2016. 2. CVRx data on file. 33 HTN patients surveyed who have been on BAROSTIM THERAPY™ for a period of at least 6 months.

Your Patient Toolkit

Patient Brochures

Find out more about how BAROSTIM THERAPY™ can help, by downloading brochures specific to your patient's condition:


Heart Failure

Hypertension

    Patient FAQs

    Can I use a mobile phone?
    Yes. When talking on a mobile phone, it is recommended to keep the antenna 15 centimetres away from BAROSTIM NEO™ and to use the phone on the ear that is opposite to where your device is located. We also recommend that you avoid leaving your mobile phone in an area (such as a breast pocket) that is near BAROSTIM NEO™.

    Are household appliances safe to use?
    Yes. Most household appliances are safe for you to use, as long as they are in good working order and properly maintained.

    Can I use other types of electrical equipment?
    Yes. When using items such as earphones, Electronic Article Surveillance (EAS) system tag deactivators, arc welders, induction furnaces, and other similar electrical or electromechanical devices, it is recommended to keep them 15 centimetres away from the BAROSTIM NEO™ device.

    Will magnets affect BAROSTIM NEO™?
    Magnets, loudspeaker magnets, and items that contain magnets (such as magnetic therapy products, handheld massagers, and stereo speakers) can temporarily affect the operation of BAROSTIM NEO™. Therefore, it is recommended that you keep such items at least 15 centimetres away from BAROSTIM NEO™. For this reason, we do not recommend the use of magnetic pillows and mattress pads.

    Will I be able to travel?
    Yes. BAROSTIM NEO™ is not affected by security scanners typically found in airports. If you have concerns about security screening methods prior to being screened, simply show your Patient Identification Card and request an alternative form of screening.

    Can I have an MRI?
    There are specific conditions under which the BAROSTIM NEO™ can be safely exposed to MRI use. Your doctor should consult the CVRx instructions for use prior to performing an MRI or any other medical procedure. 

    What should I do if I move or change doctors? 
    Ensure your contact information is correct on your Patient Identification Card. Show the card to your new doctor and suggest he or she visit  www.barostimtherapy.com for more information.

    BAROSTIM NEO Global Registry

    Real-world surveillance

    The BAROSTIM NEO™ Global Registry monitors the effect of BAROSTIM THERAPY™ in patients in a commercial setting.  Specifically, it evaluates the performance of BAROSTIM NEO™ in patients who have resistant hypertension, patients who have heart failure with reduced ejection fraction, and patients who have heart failure with preserved ejection fraction and resistant hypertension.  The BAROSTIM NEO™ Global Registry is advised by a Steering Committee of world-renowned specialists:

    The BAROSTIM NEO™ Hypertension Registry Prof. Dr. med. Michael Koziolek
    University Medical Centre Göttingen, Germany

    Prof. Dr. med. Hannes Reuter
    University Hospital of Cologne, Germany
    The BAROSTIM NEO™ HFrEF Registry Prof. Dr. med. Jochen Müller-Ehmsen
    Asklepios Clinic Altona, Germany
    The BAROSTIM NEO™ HFpEF Registry Prof. Dr. med. Burkert Pieske
    Charité University Medicine Berlin and German Heart Center Berlin, Germany

    For more information, please visit the ClinicalTrials.gov website of your interest:

    If you would like further information about the BAROSTIM NEO™ Global Registry, or would like to enroll, please send a brief message to: GlobalRegistry@cvrx.com.

     

    BAROSTIM NEO GLOBAL REGISTRY

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