The latest study results for the BackBeat cardiac neuromodulation therapy device are music to Orchestra BioMed’s ears.
The implant is meant to integrate with a patient’s existing pacemaker or other cardiac rhythm management device to help lower persistently high blood pressure. It does so by emitting patterns of bioelectronic therapy that modulate the autonomic nervous system and that can be adjusted as needed.
After presenting initial results of the Moderato II study last year showing that the BackBeat device was indeed able to reduce hypertension in its original randomized group of participants, Orchestra proceeded to transfer a handful of control group participants to the experimental cohort—and watched its technology continue to strike the right chord.
The results of the extended crossover study were presented at the annual Transcatheter Cardiovascular Therapeutics conference in Boston. In the add-on, 14 control patients transitioned to active BackBeat therapy, nine of whom had isolated systolic hypertension, an often difficult-to-treat condition in which systolic blood pressure is elevated but diastolic pressure is either normal or low.
After six months of using the implant, the crossover patients experienced an average reduction of 10.3 mmHg in their ambulatory systolic blood pressure. That’s comparable to the 8.1 mmHg drop that the original study group—about 81% of whom had isolated systolic hypertension—registered at the six-month mark.
Meanwhile, the crossover patients’ average ambulatory diastolic blood pressure saw only minimal changes, with a mean increase of 1.5 mmHg, which is a potentially desirable effect for those with isolated systolic hypertension.
“The ability to reduce systolic pressure and pulse pressure while simultaneously controlling impact on diastolic pressure may provide a unique therapeutic option for a broad range of patients, including the majority of this population, which suffers from isolated systolic hypertension,” said Daniel Burkhoff, M.D., Ph.D., a director at the Cardiovascular Research Foundation who presented the findings at the conference.
The euphonic study results come as Orchestra is tuning up its technology in preparation for a global pivotal trial that will be used to support its submission for regulatory clearance of the BackBeat system.
Its duet partner in those efforts is Medtronic, which inked a deal with Orchestra in June that’ll give the medtech giant exclusive rights to commercialize the implant once it receives marketing authorization. Until then, Medtronic will lend its development, clinical and regulatory expertise to Orchestra throughout the clinical trial, which is set to begin in the second half of 2023.