Orchestra BioMed (Nasdaq: OBIO) announced it received FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy, delivered via an implantable pacemaker system.
AVIM uses conduction system pacing to lower blood pressure in patients with elevated ASCVD risk, preserved left ventricular function, and uncontrolled hypertension—despite or intolerant to medications. Designed for rapid and lasting blood pressure reduction, AVIM is administered through a standard dual-chamber pacemaker.
The therapy is under evaluation in the FDA IDE-approved BACKBEAT global pivotal study, in collaboration with Medtronic. If approved, Medtronic will hold exclusive global commercialization rights, with Orchestra BioMed sharing revenues.
“We are delighted to have received FDA breakthrough device designation for AVIM therapy, which has the potential to offer a differentiated solution for hypertension management,” said David Hochman, Chair and CEO of Orchestra BioMed.
Dr. Robert C. Kowal of Medtronic added: “Hypertension remains a major global health challenge, especially in the pacemaker population. We are committed to advancing AVIM therapy through the BACKBEAT study.”
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