BackBeat (blood pressure lowering implant)

2022: Implant Announcement

At the end of September 2022, the BackBeat blood pressure lowering implant was released. This is a development by Orchestra BioMed.

The implant is designed to integrate with a patient's pacemaker or other heart rhythm control device to help reduce persistently high blood pressure. To do this, the device emits bioelectronic therapy samples that modulate the autonomic nervous system and that can be adjusted as needed.

BackBeat (blood pressure lowering implant)

Having presented in 2021 the initial results of the Moderato II study, which showed that the BackBeat device is indeed able to reduce the level of hypertension in the initial randomized group of participants, Orchestra BioMed transferred several participants in the control group to the experimental group and observed how its technology continues to have the desired impact.

The results of the expanded cross-sectional study were presented at the annual Transcatheter Cardiovascular Therapeutics Conference in Boston. In an additional study, 14 control patients switched to active BackBeat therapy, nine of whom had isolated systolic hypertension, often a difficult-to-treat condition in which systolic blood pressure is elevated and diastolic pressure is either normal or low.

After six months of implant use, patients in the study had a mean reduction in ambulatory systolic blood pressure of 10.3 mmHg. This compares to 8.1 mm Hg. Art., which was registered in the original study group, about 81% of them had isolated systolic hypertension, after six months. Meanwhile, the mean outpatient diastolic blood pressure in patients taking part in the study changed minimally, increasing by an average of 1.5 mmHg. Art., which is a potentially desirable effect for patients with isolated systolic hypertension.

The euphonic results of the study come as Orchestra BioMed is tweaking its technology to prepare for a global turnaround trial to be used to support regulatory approval applications for the BackBeat system.

Orchestra BioMed is partnering with Medtronic, which entered into an agreement with Orchestra BioMed in June 2022 giving the medical technology giant exclusive rights to commercialize the implant after obtaining marketing approval. Until then, Medtronic will provide its development, clinical and regulatory expertise and expertise to Orchestra BioMed throughout the clinical trial, which is due to begin in the second half of 2023.^[1]

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