BackBeat CNT

BackBeat CNT Demonstrated Safety as well as Significant and Sustained Reduction in Systolic Blood Pressure with Clinical Follow up out to 2 Years

  • MODERATO I, an open-label, single-arm, multicenter, prospective trial investigating the safety and efficacy of BackBeat Cardiac Neuromodulation Therapy (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
  • The average 24-hour ambulatory blood pressure decreased immediately after activation and remained lowered by 14.2 mmHg at 3 months after activation of 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 CNT therapy have shown that there are no significant changes in cardiac function (ejection fraction) and statistically significant trends toward improvement in sympathetic tone and end-dialstolic volume
  • 3-months data published in 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: BackBeat CNT Shifts the Entire 24-hour Ambulatory Systolic Blood Pressure Distribution to Lower Pressures

24-hour Ambulatory SBP Distribution

Systolic Pressure Bin (mmHg)

Figure 2: Ambulatory Blood Pressure Decreased Significantly Immediately After Activation and Remained Lowered by 14.2 mmHg After 3 Months of Therapy

Petr Neuzil, et. al. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017; Dec 23;6(12): e006974. DOI: 10.1161/JAHA.117.006974

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 3: Reduction in Systolic Blood Pressure Maintained Chronically

Figure 4: No Significant Changes in Cardiac Function out to 2 Years

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