Orchestra BioMed Earns 2nd FDA Breakthrough OK for Pacemaker in Hypertension

Orchestra BioMed revealed that the U.S. Food and Drug Administration (FDA) has awarded an additional breakthrough device designation (BDD) for its AVIM therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker.

The two BDDs cover the indications of the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk as well asn the pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT pivotal trial, which the company is conducting alongside Medtronic.

The additional breakthrough nod supports the clinical, regulatory, and commercial reimbursement strategies for AVIM therapy for the pacemaker population. It also supports the possible future expansion populations with uncontrolled hypertension and increased cardiovascular risk.

Atrioventricular Interval Modulation (AVIM) therapy is a bioelectronic treatment for hypertension. It’s engineered to be delivered via pacemaker and provide immediate, substantial, and sustained reductions in blood pressure in patients with hypertensive heart disease.

“We are pleased to receive this additional Breakthrough Device Designation from the FDA. We believe it is directly aligned with the patient population being studied in our ongoing BACKBEAT Trial which we are executing in collaboration with Medtronic,” said David Hochman, chairman and CEO of Orchestra BioMed. “Continued alignment from the FDA, alongside our strategic relationship with Medtronic and accelerated enrollment in the BACKBEAT Trial, puts us in a strong position to advance AVIM Therapy to pivotal trial results.”