BackBeat Cardiac Neuromodulation Therapy™ is designed to immediately, substantially and persistently lower blood pressure.
Programmable and adjustable bioelectronic therapy that immediately, substantially and persistently lowers blood pressure while simultaneously modulating the autonomic nervous system (ANS).
Can be delivered using standard rhythm management device hardware, such as dual-chamber pacemaker, utilizing the same implant procedure and lead positions.
BackBeat CNT-induced neuromodulation enables immediate, sustained and persistent reduction in blood pressure.
Utilizing proprietary active, intelligent bioelectronic signaling, BackBeat CNT stimulates the heart to immediately and persistently reduce blood pressure.
BackBeat CNT-programmed variable pressure patterns modulate ANS Response to maintain lowered blood pressure.
BackBeat CNT works automatically and in conjunction with antihypertension medications a patient may already be taking.
Readily incorporated into existing devices and paradigm of care.
Can be readily incorporated into existing cardiac rhythm management devices such as pacemakers using standard implant and lead placement techniques.
Rapidly adaptable for hypertensive patients already indicated for a pacemaker.
BackBeat CNT™ is supported by strong preclinical and clinical data. It has demonstrated statistically significant reductions in blood pressure in patients with hypertension and an indication for a pacemaker.
Delivery of BackBeat CNT significantly reduced 24-hour systolic and diastolic blood pressures in a canine model. The reduction occurred immediately upon activation of therapy and was maintained for the period that the therapy was active.
Significantly Reduced Blood Pressure
*Data on file
BackBeat CNT has shown promising clinical performance in two clinical trials:
MODERATO I, an open-label, single-arm, multi-center, prospective study of 27 patients with persistent hypertension and an indication for a pacemaker demonstrated a substantial reduction in blood pressure sustained out to 2 years.
Results Sustained Out to 2 Years (MODERATO I)
MODERATO II, a prospective, multi-center, randomized, double-blind study of BackBeat CNT vs. Medical Therapy in 47 patients with persistent hypertension and an indication for pacemaker met the primary efficacy and safety endpoints and had a high responder rate despite 88.5% of patients with isolated hypertension.
Between Groups Reduction in ASBP
Between Groups Reduction in OSBP
Significant Reduction in ASBP (mmHg) at 6 months†
Significant Reduction in OSBP (mmHg) at 6 Months††
†24-Hours ASBP (mmHg) at 6 months Post-Randomization vs. Week 3 Run-in.
††24-Hours OSBP (mmHg) at 6 Months Post-Randomization vs. Week 4 Run-In
*Major Cardiac Advance Events (MACE) included death, heart failure, clinically significant arrhythmias (i.e., persistent or increased atrial fibrillation, serious ventricular arrhythmias), myocardial infarction, stroke and renal failure in treatment group calculated per patient
**Responder rate: % of patients with reduction in ASBP in the treatment group
BackBeat CNT™ is not approved for commercial use in the US
© 2021 Orchestra BioMed Inc. Virtue®, BackBeat CNT™ FreeHold Duo®, FreeHold Trio® and Orchestra BioMed™ are trademarks of Orchestra BioMed.
All other trademarks are trademarks of their respective owners.
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