Orchestra BackBeat - Model CNT - Cardiac Neuromodulation Therapy Technology
From Medical Devices
BackBeat CNT™ is a patented bioelectronic treatment for hypertension that is designed to drive an immediate, substantial and persistent reduction in blood pressure while simultaneously modulating autonomic nervous system responses to maintain lowered blood pressure long-term. A patented, intelligent bioelectronic treatment for hypertension. BackBeat Cardiac Neuromodulation Therapy is designed to immediately, substantially and persistently lower blood pressure.
Patented Intelligent Bioelectronic Therapy
BackBeat CNT-induced neuromodulation enables immediate, sustained and persistent reduction in blood pressure.
Immediately lowers blood pressure
Utilizing proprietary active, intelligent bioelectronic signaling, BackBeat CNT stimulates the heart to immediately and persistently reduce blood pressure.
Maintains Reduction Over Time
BackBeat CNT-programmed variable pressure patterns modulate ANS Response to maintain lowered blood pressure.
Avoids relying on patient medication adherence or compliance
BackBeat CNT works automatically and in conjunction with antihypertension medications a patient may already be taking.
Leveraging Standard Rhythm Management Devices
Readily incorporated into existing devices and paradigm of care.
Can be incorporated into existing devices
Can be readily incorporated into existing cardiac rhythm management devices such as pacemakers using standard implant and lead placement techniques.
Adaptable to the existing paradigm of care
Rapidly adaptable for hypertensive patients already indicated for a pacemaker.
Technology
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.
Data
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.
Preclinical
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.
Clinical
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.
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.
- 8.11mmHg: Between Groups Reduction in ASBP
- 12.3mmHg: Between Groups Reduction in OSBP
- 0% MACE*
- 85% Responder Rate**
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