NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced that its atrioventricular interval modulation (AVIM) therapy has received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA). The innovative therapy aims to address uncontrolled hypertension in high-risk patients, a population estimated at over 7.7 million in the United States.
AVIM therapy is delivered through an implantable system and targets patients with elevated cardiovascular risk and persistent hypertension unresponsive to medications. It is also designed for pacemaker-indicated patients, a key focus of the ongoing BACKBEAT global pivotal study. This trial, conducted in collaboration with Medtronic, is evaluating the therapy’s potential in improving outcomes for hypertensive patients who rely on pacemakers.
“We are delighted to have received FDA Breakthrough Device Designation for AVIM therapy which has the potential to offer a differentiated, advantageous solution for hypertension management in a broad population,” said David Hochman, Chairman and CEO of Orchestra BioMed.
The FDA’s Breakthrough Devices Program emphasizes swift development and review of cutting-edge medical technologies that address serious or life-threatening conditions. This designation highlights AVIM therapy’s potential to enhance blood pressure control by reducing morbidity and mortality in high-risk groups.
Robert C. Kowal, M.D., Ph.D., Vice President at Medtronic, added, “Hypertension remains a significant global public health challenge that is especially relevant to the pacemaker population as the most common comorbidity in these patients.” He underlined Medtronic’s commitment to advancing AVIM therapy through its partnership with Orchestra BioMed.
Orchestra BioMed’s strategic collaboration with Medtronic extends to the broader development and commercialization of AVIM therapy, with Medtronic holding potential global rights for patients outside the pacemaker indication.
This FDA recognition marks another significant step in addressing critical unmet needs in hypertension management and advancing innovative cardiovascular solutions.
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