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 distance, 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