[Image courtesy of Orchestra Biomed]
Researchers found AVIM therapy acutely lowered systolic blood pressure and improved left ventricular volumes, with sustained benefits in patients treated chronically. The AVIM therapy is currently being evaluated in a global pivotal trial in collaboration with Medtronic.
Orchestra Biomed’s AVIM therapy, known as BackBeat Cardiac Neuromodulation Therapy, is a pacemaker-based approach to treating hypertension. The system adjusts the timing of contractions between the upper and lower chambers of the heart to ease filling pressure and lower vascular resistance.
The company said that early studies have shown the therapy can reduce systolic blood pressure quickly and sustain the effect over time. Because it is delivered through a dual-chamber pacemaker, it may benefit patients who already need pacing and remain at high cardiovascular risk despite medication.
Orchestra BioMed says atrioventricular interval modulation (AVIM) therapy uses standard dual-chamber pacemaker implants with standard leads. [Image courtesy of Orchestra BioMed]
The full study results were published in JACC: Clinical Electrophysiology.
“Pressure-volume loop analysis is regarded as the gold standard for assessing systolic and diastolic function as well as reverse remodeling. These results provide powerful insights on the impact of AVIM therapy to both decrease blood pressure and favorably impact ventricular end-diastolic volume without compromising cardiac output or increasing workload,” said Dr. Daniel Burkhoff, director of Heart Failure, Hemodynamics, and MCS Research at the Cardiovascular Research Foundation. “Notably, these favorable effects were observed consistently and with different pacing lead locations, demonstrating the versatility of AVIM therapy. Publication of these data in a prestigious peer-reviewed journal such as JACC: Clinical Electrophysiology provides further validation from the clinical community reinforcing the therapeutic rationale behind AVIM therapy and further highlighting its potential to deliver differentiated clinical benefit for patients with uncontrolled hypertension.”
Yuval Mika, executive vice president of bioelectronic therapies at Orchestra BioMed, said the data highlight AVIM therapy’s potential to reduce blood pressure and induce positive reverse remodeling, with possible applications in preventing or treating heart failure.
“The publication of the PV loop data in JACC: Clinical Electrophysiology marks another important milestone showcasing AVIM therapy’s potential ability to significantly reduce blood pressure and favorably impact cardiac function in hypertensive patients with increased cardiovascular risk. The consistent reduction seen in cardiac preload, as well as cardiac afterload with both CSP and RV lead placements in these pilot studies demonstrates that AVIM therapy’s mechanism of action works regardless of lead location,” Mika said. “Furthermore, acute and chronic PV loop results indicate AVIM therapy’s potential to induce positive reverse remodeling of ventricular hypertrophy, highlighting potential to prevent or even treat heart failure. We continue to believe that AVIM therapy has the potential to reshape the standard of care for higher risk patients with uncontrolled hypertension in the pacemaker population and beyond.”
