Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial.
BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker.
New Hope, Pennsylvania-based Orchestra BioMed has the backing of medtech giant Medtronic in this effort. The companies announced a strategic collaboration to develop and commercialize AVIM therapy for pacemaker patients in July 2022. Under the collaboration, Medtronic offers development, clinical and regulatory support for the BACKBEAT trial.
Medtronic also contributed to a $110 million Series D at Orchestra BioMed, which soon went public through a …