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# Breakthrough Status for Blood Pressure Therapy
- URL: https://www.fdaweb.com/breakthrough-status-for-blood-pressure-therapy/
- Published: 2025-04-25T12:00:00.000Z
- Updated: 2026-09-14T15:10:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159071

FDA has granted Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy, a pacemaker that uses conduction pacing to reduce blood pressure in patients with increased 10-year atherosclerotic cardiovascular disease 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.

AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study in collaboration with Medtronic, the company says. It is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation for which Orchestra BioMed believes the therapy may offer optimal clinical benefit.