Orchestra BioMed wins FDA breakthrough nod for hypertension treatment

Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy.

The breakthrough nod covers Orchestra BioMed’s implantable pacemaker system that delivers AVIM therapy. It uses conduction system pacing to reduce blood pressure in patients with increased 10-year atherosclerotic cardiovascular disease (ASCVD) risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications.

A patented bioelectronic therapy, AVIM, is administered using a standard dual-chamber pacemaker. Orchestra BioMed designed it to immediately, substantially and persistently reduce blood pressure.

Sign up for Blog Updates