Orchestra BioMed Holdings, Inc. has published promising new data in *JACC: Clinical Electrophysiology*, highlighting the effectiveness of its atrioventricular interval modulation (AVIM) therapy. This therapy aims to reduce blood pressure and enhance heart function in patients suffering from uncontrolled hypertension who also require a pacemaker.
The recent findings are based on acute and chronic pressure-volume loop studies, which are considered the gold standard for evaluating cardiac performance. The results revealed statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance, and stroke work, all achieved without adversely affecting stroke volume or heart contractility. In a subgroup from the MODERATO II trial, 16 patients underwent invasive monitoring while 32 patients were assessed non-invasively. The AVIM therapy demonstrated an average reduction in systolic blood pressure of **17.1 mmHg** with right ventricular pacing and **19.2 mmHg** with conduction system pacing, contrasting sharply with the modest **1.7 mmHg** reduction associated with standard pacing techniques.
Clinical Insights and Implications
Long-term application of AVIM therapy indicated sustained decreases in both blood pressure and ventricular volumes, suggesting favorable remodeling of the heart muscle. Dr. Daniel Burkhoff, the director of heart failure and hemodynamics research at the Cardiovascular Research Foundation, remarked, “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.”
Adding to this, Yuval Mika, executive vice president of bioelectronic therapies at Orchestra BioMed, emphasized that these findings highlight AVIM’s potential to reshape care standards for high-risk patients with uncontrolled hypertension, particularly within the pacemaker population.
Strategic Collaboration and Market Potential
AVIM therapy has received the **FDA Breakthrough Device Designation** and is currently being evaluated in the global pivotal BACKBEAT study, conducted in collaboration with Medtronic. Each year, over **750,000 patients** worldwide receive pacemakers, many of whom also contend with hypertension. Orchestra BioMed estimates that **over 7.7 million** patients in the United States could eventually benefit from this innovative therapy.
The peer-reviewed publication reinforces the evidence supporting AVIM therapy as Orchestra BioMed and Medtronic work towards regulatory approvals and future commercialization. As the clinical landscape evolves, the implications of these findings may significantly impact treatment protocols for individuals facing dual challenges of hypertension and the need for pacing devices.
