Key Study Results

Key Study Results

Rheos® Pivotal Hypertension Trial

The effectiveness and safety of the Rheos System was evaluated in the Rheos Pivotal Trial.  A total of 322 resistant hypertension patients participated in the trial. A subset of 60 patients from this trial had images of their heart taken prior to having the Rheos implant and after 12 months of therapy.

Key Findings:

  • 13% reduction of left ventricular mass

Average_left_ventricle_mass_index

Source: Bisognano JD, et al. Journal of Clinical Hypertension 2009; 11(Suppl A, no.4) A1

Pressure Volume Study

In a pressure volume study by Wachter R. et al, PV loop images were taken of a 78 year old male patient who had received 12 months of Barostim Therapy™  to evaluate the therapy’s impact on heart structure and function. The below PV loops demonstrate that Barostim Therapy significantly improves cardiac function by increasing the stroke volume and reducing the arterial resistance.
PV Loops

Source: Wachter R. et al. Artery Research 2011(5) 4:166-167.

 

Barostim neo™ Heart Failure Study

11 patients with HFrEF enrolled in an open-label study of  Barostim neo. Therapeutic effect was measured by chronic changes in NYHA functional class, Minnesota living with HF questionnaire, 6-minute walk distan ce, and estimated glomerular filtration rate (eGFR).

Key Findings:

  • Reduction in the pathologic elevation of sympathetic nerve activity present in HFrEF
  • Improved 6-minute hall walk
  • Improved NYHA class

HF barostim 1

HF barostim 2

Source:  Gronda et al., AHA 2012

 

Barostim neo® Randomized Controlled Trial for Heart Failure

A 146-patient, prospective, randomized, controlled clinical study to determine efficacy and safety for patients with heart failure has been completed.

Participating centers were from Europe and North America.  Key patient characteristics were NYHA Class III and LVEF ≤ 35%.  Patients were randomized to Barostim Therapy® plus medical management or to medical management.  Results were presented at the 2015 American College of Cardiology at a Featured Clinical Research Session and simultaneously published in JACC-HF: “Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction”¹.

Key Findings:

  • Barostim Therapy safe in heart failure with reduced ejection fraction (HFrEF) patients
  • Improved 6-minute hall walk
  • Improved patients’ quality of life (Minnesota Living with Heart Failure Questionnaire)
  • Had a positive effect on LV ejection fraction
  • Improved patients’ NYHA classification
  • Reduced NTproBNP levelsReduced heart failure hospitalizations

CVRX_6_Month_NYHA_class_chart_051315

CVRx_Quality_of_Life_chart_051315CVRx_6min_walk_chart_051315
CVRX_NT-proBNP_chart_051315
CVRX_LVEF_chart_051315

CVRX_HF_hospitalization_chart2_051315

¹Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC, Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction, JACC: Heart Failure (2015), doi: 10.1016/j.jchf.2015.02.006.
Disclaimer for Canadian Healthcare Professionals:  Exclusively for clinical investigations