- FDA awards Breakthrough Device Designation to Orchestra BioMed's AVIM therapy, highlighting its potential in treating hypertension.
- Over 7.7 million U.S. patients could benefit from the therapy, targeting those with dual-chamber pacemakers and uncontrolled hypertension.
- Orchestra BioMed to present AVIM therapy findings at a symposium during the HRS 2025 Annual Meeting in San Diego.
Orchestra BioMed Holdings, Inc. (OBIO, Financial) has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy. This designation is aimed at patients with uncontrolled hypertension who are at increased cardiovascular risk, making it a significant milestone in addressing unmet medical needs.
The AVIM therapy utilizes a novel cardiac pacing intervention, showing promise in clinical studies to significantly reduce systolic blood pressure and improve cardiac function. Orchestra BioMed estimates a target market of over 7.7 million patients in the U.S. who meet the criteria for this therapy.
To further evaluate the therapy's effectiveness, Orchestra BioMed is currently enrolling patients in the BACKBEAT global pivotal study, conducted in collaboration with Medtronic (MDT). This study is aimed at assessing the therapy's impact on patients with dual-chamber pacemakers who have not achieved target blood pressure levels despite anti-hypertensive medication.
The findings and advancements of the AVIM therapy are set to be showcased on April 25, 2025, at a satellite symposium during the Heart Rhythm Society (HRS) 2025 Annual Meeting in San Diego, California. The event will feature presentations from leading experts in the field, detailing clinical results from prior studies demonstrating AVIM therapy's sustained impact on lowering blood pressure and enhancing heart health.
