Clinical Data

Clinical study demonstrated significant and sustained reduction in office systolic blood pressure

  • MODERATO I, an open-label, single-arm, multicenter, prospective trial investigating the safety and efficacy of BackBeat® CNT pacing therapy in patients with persistent hypertension indicated for implantation or replacement of pacemaker, was conducted in Europe and Chile
  • Twenty seven (27) patients with persistent oSBP>140mm HG after 1-month of conventional pacing were included in the study
  • Compared with pre-PHC therapy activation measurements, office systolic blood pressure (oSBP) decreased by 16 mmHg at 3 months, which corresponded to a 24 mmHg drop from baseline values. The average 24-hour ambulatory systolic blood pressure (ASBP) decreased by 15 mmHg at 3 months after activation of PHC therapy compared with baseline. No device-related serious adverse effects were noted
  • Long-term (24-month) data continues to support sustained reduction in systolic blood pressure. In addition, comparison of Echocardiograms performed at baseline and following activation up to two years of BackBeat PHC therapy have shown that there are no significant changes in cardiac function (ejection fraction)
  • 3-months data published the American Heart Association Journal.
  • Positive 2-year clinical results from Moderato I clinical trial presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 in San Diego, CA.

Figure 1

Long-term (24-month) data continues to support sustained reduction in systolic blood pressure. In addition, comparison of Echocardiograms performed at baseline and following activation up to two years of BackBeat® PHC therapy have shown that there are no significant changes in cardiac function (ejection fraction).

Figure 2: Reduction in Systolic blood pressure maintained chronically

Interim data, adjudication pending

Figure 2: No significant changes in cardiac function out to 2 years

Interim analysis - pending final data
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