Orchestra BioMed announced an FDA-approved protocol update for its BACKBEAT global pivotal study, significantly expanding patient eligibility criteria for AVIM therapy. This update results in an estimated more than 24-fold increase in the potentially eligible patient pool compared to the original study protocol.
The expanded eligibility now includes screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements. This broadens the scope of the study for the atrioventricular interval modulation (AVIM) therapy, developed in collaboration with Medtronic.
This milestone is crucial for accelerating the clinical development and eventual market adoption of AVIM therapy for uncontrolled hypertension. The increased patient pool for the BACKBEAT study enhances the potential for robust data collection and faster progress towards regulatory approval and commercialization.
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