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.
AVIM currently has FDA investigational device exemption (IDE) for the BACKBEAT global pivotal study, conducted in collaboration with Medtronic. Orchestra BioMed formed a strategic collaboration around its AVIM therapy with Medtronic in July 2022. If approved, Medtronic has exclusive global rights to commercialize AVIM-enabled pacing systems for this target population. Under the agreement, Orchestra BioMed shares in the revenues generated by these technologies.
Commentary from Orchestra BioMed and Medtronic officials
David Hochman, chair and CEO of Orchestra BioMed outlined his excitement in a news release:
“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,” said David Hochman, chair and CEO 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.
Hochman said the breakthrough nod “recognizes the potential of this unique therapy” in benefitting an expanded number of patients.
Dr. Robert C. Kowal, VP and GM of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit, added his thoughts:
“We are very pleased that AVIM therapy received breakthrough device designation, a recognition of the potential of AVIM therapy to address unmet needs in hypertension management,” said Kowal. “Hypertension remains a significant global public health challenge that is especially relevant to the pacemaker population as the most common comorbidity in these patients. Medtronic is committed to collaborating with Orchestra BioMed to advance this innovative, investigational therapy through the BACKBEAT global pivotal study.”
