Orchestra BioMed’s Hypertension Device Wins FDA Breakthrough Designation

Orchestra BioMed’s Hypertension Device Wins FDA Breakthrough Designation

Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. Medtronic has a commercialization deal with the company for the device, which uses a pacing algorithm to actively lower blood pressure in people with pacemakers. The post Orchestra BioMed’s Hypertension Device Wins FDA Breakthrough Designation appeared first on MedCity News.

Orchestra BioMed receives Breakthrough Device Designation for its hypertension therapy

The company received the designation for its atrioventricular interval modulation therapy, a novel pacemaker-based treatment aimed at reducing blood pressure in patients with uncontrolled hypertension and elevated cardiovascular risk.

Orchestra BioMed to Highlight Advancements in Cardiac Therapy at HRS 2025

NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) will host a satellite symposium at the Heart Rhythm Society (HRS) 2025 Annual Meeting in San Diego to spotlight its atrioventricular interval modulation (AVIM) therapy. The event, scheduled for April 25, will discuss the therapy’s potential to address hypertension in patients at increased cardiovascular risk. The symposium follows the U.S. Food and Drug Administration’s recent grantin…

A Pacemaker to Control BP Gets FDA Breakthrough Designation

The device is designed to lower blood pressure while simultaneously modulating the autonomic nervous system by delivering repeated sequences of shorter and longer atrioventricular delays.

FDA Awards Breakthrough Device Designation to AVIM Therapy for Hypertension

Orchestra BioMed’s Breakthrough Device designation could apply to nearly 8 million patients with uncontrolled hypertension and increased cardiovascular risk

Atrioventricular interval modulation therapy granted US FDA breakthrough designation - Cardiovascular News

Orchestra BioMed Holdings has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for atrioventricular interval modulation (AVIM) therapy. The breakthrough device designation is for an implantable system (i.e. a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease (ASCVD) risk, preserve…