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Orchestra BioMed Announces Publication of Clinical Data Demonstrating Favorable Blood Pressure and Hemodynamic Effects of AVIM Therapy in JACC: Clinical Electrophysiology
Globenewswire· 2025-08-26 11:30
Core Viewpoint - Orchestra BioMed Holdings, Inc. announced favorable hemodynamic effects of AVIM therapy for patients with uncontrolled hypertension, as published in the Journal of the American College of Cardiology: Clinical Electrophysiology [1][2][3] Group 1: AVIM Therapy Findings - AVIM therapy demonstrated statistically significant reductions in systolic blood pressure (SBP) by an average of 17.1 mmHg (RV pacing) and 19.2 mmHg (CSP), compared to 1.7 mmHg with standard pacing [6] - The therapy improved left ventricular hemodynamics, with end-diastolic volume decreasing by 12.6 mL (RV) and 18.6 mL (CSP), and end-systolic volume decreasing by 11.0 mL (RV) and 14.1 mL (CSP) [6] - AVIM therapy also significantly reduced cardiac workload, with stroke work decreasing by 1,596 mL (RV) and 1,870 mL (CSP), compared to 42 mL with standard pacing [6] Group 2: Clinical Implications - The publication of the data in a peer-reviewed journal reinforces the therapeutic rationale behind AVIM therapy, highlighting its potential to deliver differentiated clinical benefits for patients with uncontrolled hypertension [3][7] - AVIM therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk, estimated to be over 7.7 million patients in the U.S. [5][10] - The strategic collaboration between Orchestra BioMed and Medtronic aims to develop AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients, a population of over 750,000 patients annually [5][10] Group 3: Research and Development - The BACKBEAT global pivotal study is currently evaluating the safety and efficacy of AVIM therapy in patients with systolic blood pressure above target despite anti-hypertensive medication [10] - The MODERATO II study showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [10] - AVIM therapy is compatible with standard dual-chamber pacemakers and aims to substantially and persistently lower blood pressure [10]