Orchestra BioMed receives FDA BDD for AVIM therapy

Orchestra BioMed (OBIO) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation, BDD, for atrioventricular interval modulation, AVIM, therapy. “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,” commented David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “Patients at higher risk for mortality and morbidity associated with high blood pressure are the core of the population we are actively enrolling in the BACKBEAT global pivotal study of hypertensive pacemaker-indicated patients in collaboration with Medtronic. The FDA Breakthrough Device Designation recognizes the potential of this unique therapy to benefit a significantly expanded number of patients who are not indicated for a pacemaker but who also have uncontrolled hypertension and increased cardiovascular risk. We are committed to working closely with the FDA, Medtronic and the clinical community to maximize the impact of AVIM therapy.”