NEW HOPE, PA — A new development in the management of hypertension could be a game-changer for patients with uncontrolled high blood pressure. Orchestra BioMed Holdings, Inc., a leading innovator in bioelectronic medicine, revealed data this week that shows the long-term efficacy of its atrioventricular interval modulation (AVIM) therapy, known commercially as BackBeat CNT™.
The data, presented by Dr. Avi Fischer, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed, during the Innovation in Cardiovascular Interventions 2024 Meeting, shows that AVIM therapy can significantly reduce 24-hour ambulatory systolic blood pressure (aSBP) in patients who require pacemakers. This is a significant finding given that many of these patients have hypertension that remains uncontrolled despite the use of antihypertensive medications.
Hypertension can place a significant burden on patients, requiring lifelong management. This condition is particularly concerning for older patients who require pacemakers and may face a higher risk of other co-morbidities and adverse clinical outcomes.
The MODERATO II study, a European multi-center, double-blind, randomized pilot study involving 47 subjects, was used to test the effectiveness of AVIM therapy. The primary endpoint of the study was the reduction in aSBP measured at six months from randomization and therapy activation. Patients who were randomized to receive both AVIM therapy and antihypertensive medication experienced an 11.1 mmHg reduction in mean aSBP at the six-month follow-up, resulting in a statistically significant difference of 8.1 mmHg compared to control patients who only received antihypertensive medications.
Long-term blood pressure results were obtained from a follow-up study of 16 patients initially enrolled in the MODERATO II study. This group included eight patients from the AVIM treatment arm and eight control arm patients who switched to AVIM therapy at the end of the six-month double-blind phase. The aSBP of each patient was measured an average of 3.6 years after the initial initiation of AVIM therapy. Both as a group and based on individual paired data, these patients continued to experience a statistically significant, clinically meaningful mean aSBP reduction of 8.9 mmHg.
AVIM therapy is administered using a standard dual-chamber pacemaker and is designed to immediately, substantially, and persistently reduce blood pressure. In July 2022, Orchestra BioMed entered into a strategic collaboration with Medtronic plc for the development and commercialization of AVIM therapy for hypertensive pacemaker patients. If AVIM therapy earns approval from the U.S. Food and Drug Administration, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of these systems.
Currently, Orchestra BioMed is actively enrolling patients in the BACKBEAT pivotal study. This study aims to investigate the efficacy and safety of AVIM therapy in patients who have recently undergone implantation of a Medtronic dual-chamber cardiac pacemaker and have uncontrolled hypertension despite the use of antihypertensive medications. The primary efficacy endpoint of the study will determine whether AVIM-treated patients experience a statistically significant reduction in aSBP compared to control patients at three months post-randomization.
This promising development from Orchestra BioMed could represent a significant advance in the management of hypertension, providing hope for patients with uncontrolled high blood pressure.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.