Orchestra BioMed Holdings, Inc. has unveiled promising clinical findings regarding its atrioventricular interval modulation (AVIM) therapy, suggesting it could significantly enhance heart function in patients suffering from hypertension and diastolic dysfunction. These two conditions are major contributors to heart failure with preserved ejection fraction (HFpEF). The results, published in the journal JACC: Advances, arise from a retrospective, treatment-blinded analysis of participants in the MODERATO II trial.
The study highlights that AVIM therapy not only resulted in a reduction of blood pressure but also improved critical measures of diastolic function. This advancement could have far-reaching implications for millions of individuals at risk of developing HFpEF. Over a six-month period, patients treated with AVIM experienced an average decrease in office systolic blood pressure of 12.1 mmHg, while ambulatory readings fell by 8.3 mmHg. Additionally, echocardiographic assessments revealed significant improvements in myocardial relaxation and compliance, evidenced by marked increases in e′ velocity and the E/A ratio.
Significance of the Findings
Dr. Marat Fudim, the study’s lead author and a representative from Duke Health, emphasized the connection between chronic hypertension, diastolic dysfunction, and the eventual onset of HFpEF. He stated, “There is a clear clinical link between long-standing hypertension, diastolic dysfunction, and the eventual development of HFpEF, yet few interventions are available that effectively target this pathway.” Dr. Fudim noted that the dual effects of AVIM therapy—both in lowering blood pressure and improving ventricular compliance—suggest significant potential for disease modification and reverse remodeling.
Dr. Avi Fischer, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed, acknowledged the escalating healthcare burden posed by the transition from uncontrolled hypertension to HFpEF, which currently has limited treatment options. He pointed out that AVIM’s device-based approach could facilitate earlier intervention by addressing both high systolic pressure and impaired diastolic function.
Future Developments and Regulatory Plans
The AVIM therapy is currently undergoing further evaluation in the BACKBEAT global pivotal study, which is conducted in collaboration with Medtronic. This study aims to gather additional data to support a potential U.S. regulatory approval specifically for pacemaker-indicated patients experiencing uncontrolled hypertension. The results from this ongoing research could pave the way for broader adoption of AVIM therapy in clinical practice.
As the healthcare community continues to seek effective therapies for managing hypertension and its complications, Orchestra BioMed’s innovative approach may play a crucial role in transforming care for patients at risk of heart failure. The ongoing advancements in this field highlight the importance of continued research and development to address significant health challenges facing populations worldwide.
