Orchestra BioMed announces rollout of FDA-approved BACKSEAT study update

Orchestra BioMed (OBIO) announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration, FDA, that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. Key updates to eligibility criteria now include patients with: Medtronic Astra or Azure dual-chamber pacemakers with sufficient battery life implanted for any reason; Medtronic Astra or Azure dual-chamber pacemakers that are first device implants or implanted to replace an existing pacemaker; and New York Heart Association class I or class II symptomatic heart failure.