Echocardiographic analysis from the MODERATO II study suggests that atrioventricular interval modulation (AVIM) therapy has a positive impact on diastolic dysfunction in patients, a critical factor in the development of heart failure with preserved ejection fraction (HFpEF). Hypertension, the primary driver of diastolic dysfunction, is also the most frequent comorbidity in older patients requiring pacemakers.
Orchestra BioMed announced the publication of this data in JACC: Advances, emphasizing AVIM therapy’s significant improvement in cardiac function for patients with both hypertension and diastolic dysfunction – key precursors to HFpEF. The retrospective, treatment-blinded analysis of MODERATO II patients showed that AVIM therapy significantly reduced systolic blood pressure (both in the office and during ambulatory monitoring) and improved echocardiographic markers of diastolic dysfunction. This builds on earlier presentations of these findings at the 2025 Technology and Heart Failure Therapeutics Meeting.
This publication reinforces Orchestra BioMed’s strategic positioning of AVIM therapy as a potential solution for the growing and costly challenge of managing the progression from uncontrolled hypertension to HFpEF. Current treatment options remain limited, especially for the substantial segment of pacemaker patients also presenting with hypertension. By targeting both elevated systolic blood pressure and impaired diastolic function, AVIM therapy offers a device-based approach for earlier intervention in disease progression.
The impact of these findings extends beyond Orchestra BioMed. Sites and physicians gain a potential new tool for managing a complex patient population, particularly those at higher risk for serious cardiovascular events. For Medtronic, Orchestra BioMed’s collaborator in the ongoing BACKBEAT pivotal study, these results further validate their investment in a novel technology that could significantly expand their presence in the hypertension management market. Moreover, positive results from the BACKBEAT study could potentially influence payer coverage decisions, making AVIM therapy more accessible to a broader patient base.
The ongoing BACKBEAT study, designed to support US regulatory approval for AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension, becomes even more critical. The study’s success hinges on replicating and extending these positive signals, demonstrating not only blood pressure reduction but also sustained improvement in diastolic function and long-term cardiovascular outcomes. The results could reshape the treatment landscape for hypertension and HFpEF, potentially shifting clinical practice toward earlier, more proactive interventions. The interplay between pharmaceutical approaches and device-based therapies, such as AVIM, will be a key area to watch as this technology matures.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
