Barostim Baroflex Activation Therapy | PIH Health | Whittier, CA

Barostim Baroflex Activation Therapy

Image of Barostim device

Barostim Baroflex Activation Therapy uses neuromodulation – the power of the brain and nervous system – to improve symptoms for patients with systolic heart failure (HFrEF). Barostim is delivered by the Barostim NEO Generator™, an implantable device that uses a patented technology to send electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors trigger the body’s baroreflex which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduces the symptoms of heart failure (HF). Barostim NEO received FDA Breakthrough Device Designation and is FDA-approved for use in HF patients in the US. It has also received the CE Mark for HF and resistant hypertension in the European Economic Area.

Minimally Invasive and Safe

Picture of Barostim device within the body

  • Barostim can be implanted in an electrophysiology or catheterization laboratory as an outpatient procedure
  • 79% of study patients already had an implanted cardiac device[1]
  • System is completely subcutaneous, without hardware in the heart or vasculature
  • Therapy tailored to patient, and system is fully reversible
  • Safety was demonstrated with a device or procedure related to major adverse neurological or cardiovascular event-free rate of 97%1, 2

 

 

 

 



[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180050

Of the 125 subjects implanted, there were 4 events: 2 infections requiring explant, 1 acute decompensated heart failure event, and 1 stroke