Atrioventricular Interval Modulation (AVIM) therapy is designed to substantially, immediately and persistently lower blood pressure.
Programmable and adjustable bioelectronic therapy designed to lower blood pressure while simultaneously modulating the autonomic nervous system (ANS).
Designed to leverage standard rhythm management device hardware, such as dual-chamber pacemaker, utilizing the same implant procedure and lead positions.
Designed to immediately, substantially and persistently lower blood pressure
Designed to substantially lower blood pressure through programmed pacing
Designed to maintain reduction by modulating autonomic nervous system (ANS) response through programmed variable pressure patterns
Designed to work automatically without relying on patient compliance with background antihypertension medications
Designed to readily incorporate into existing devices and treatment pathways
Can be readily incorporated into existing cardiac rhythm management devices such as pacemakers using standard implant and lead placement techniques
Designed to be rapidly adaptable for hypertensive patients already
indicated for a pacemaker
Atrioventricular interval modulation (AVIM) therapy is supported by encouraging preclinical and clinical data. In MODERATO I and II pilot studies, the therapy demonstrated statistically significant reductions in blood pressure in patients with hypertension and an indication for a pacemaker.
AVIM therapy showed promising results in MODERATO II, a prospective, multi-center, randomized, double-blind study of pacemaker patients with persistent hypertension including 88.5% with isolated systolic hypertension (ISH).
mmHg 24-Hour aSBP at 6 months
MACE at 6 months
mmHg in oSBP at 2 years
of patients with reduction in aSBP
Results were presented during the Breakthrough Science Session at TCT 2019 Data published in the American Heart Association journal
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.
mmHg 24-Hour aSBP at 3 months
mmHg in oSBP at 2 years
of patients with reduction in aSBP
Preclinical Delivery of AVIM therapy 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 its full duration.
Orchestra BioMed entered into a global strategic collaboration with Medtronic to develop AVIM therapy as a bioelectronic treatment for hypertension in patients indicated for a cardiac pacemaker.
"As the global leader in advanced cardiac pacing therapies, Medtronic is the ideal partner to help us develop AVIM therapy for the treatment of hypertension, which is remarkably common and drives significant health risk in the pacemaker population. This exemplifies our commitment to accelerating high-impact medical innovations with global medical technology leaders."
"Our collaboration with Orchestra BioMed will explore how cardiac pacing can go beyond management of bradycardia and conduction disease to treat hypertension as well. Our goal is to deliver the best possible outcomes for patients; the collaboration on AVIM therapy will help us understand this innovative treatment's potential role in managing hypertension, a major source of cardiovascular illness and a comorbidity in more than 70% of patients receiving pacing therapy."