FDA grants IDE approval for Orchestra BioMed's BACKBEAT pivotal study of BackBeat CNT in hypertensive pacemaker patients

Orchestra BioMed Holdings, Inc.

FDA approved IDE for global pivotal BACKBEAT study evaluating AVIM therapy (BackBeat CNT) for hypertension in pacemaker patients.
Study to randomize ~500 patients 1:1, primary endpoint: change in mean 24-hour ambulatory systolic BP at 3 months.
Orchestra BioMed collaborating with Medtronic; Medtronic has exclusive global commercialization rights if approved.
Supported by MODERATO II pilot study: net reduction of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in oSBP at 6 months.
Enrollment expected to start before end of 2023; study designed to support future regulatory review and potential approval.

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