Pacemaker-Like Implant Cleared in Europe to Lower Blood Pressure

Orchestra BioMed, a company out of New Hope, Pennsylvania, won the European CE Mark of approval for the Moderato implantable pulse generator which delivers Orchestra’s unique BackBeat Cardiac Neuromodulation Therapy (CNT) to treat hypertension.

High blood pressure is typically treated using drugs, but BackBeat allows even existing cardiac implants to deliver therapy in a novel way by modulating the bioelectronic signals associated with blood pressure control.

In Europe, the MODERATO I clinical trial showed that BackBeat can lower systolic blood pressure by an average of 23 mmHg after a two-year follow up. That’s pretty impressive, as that should lead to lower potential for cascading conditions while increasing overall health.

“BackBeat CNT is an exciting new approach to device-based blood pressure management and has potential to be a primary treatment modality for the more than two-thirds of pacemaker patients at risk from hypertension,” said Dr. Karl-Heinz Kuck, MD., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany and principal investigator for the MODERATO studies, which evaluated the BioBeat technology. “In the MODERATO I clinical trial, BackBeat CNT demonstrated excellent efficacy and safety results, particularly given that 78% of the study patients had isolated systolic hypertension and that the patient average baseline ambulatory systolic blood pressure (137 mmHg) was lower compared with patients in other device-based hypertension studies. I look forward to presenting the six-month primary endpoint results from the MODERATO II study of BackBeat CNT as a late-breaker at TCT [Transcatheter Cardiovascular Therapeutics conference] later this month.”

Here’s a Orchestra BioMed video that presents the BackBeat system and explains its workings:

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Product page: BackBeat Cardiac Neuromodulation Therapy (CNT)

Via: Orchestra BioMed

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