Orchestra granted additional breakthrough device designation for AVIM therapy

Orchestra BioMed (OBIO) announced that the FDA has granted a second breakthrough device designation, or BDD, for AVIM therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker. Together, the two BDDs for AVIM therapy cover indications that encompass both the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk as well as the specific pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT trial, which Orchestra BioMed is conducting in collaboration with Medtronic (MDT).