Orchestra BioMed wins FDA breakthrough nod for pacemaker in hypertension

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

AVIM (atrioventricular interval modulation) uses conduction system pacing to immediately, substantially and persistently reduce blood pressure. The patented bioelectronic therapy comes through a standard dual-chamber pacemaker. New Hope, Pennsylvania–based Orchestra won its first FDA breakthrough device designation for AVIM therapy last year.

Today, the company says the FDA granted a breakthrough nod for AVIM therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker.

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