Orchestra BioMed earns CE mark for BackBeat cardiac neuromodulation therapy

Orchestra BioMed, Inc., on Sept. 4 announced it received CE mark approval for its Moderato implantable pulse generation system, which delivers the company’s trademarked cardiac neuromodulation therapy to patients while simultaneously acting as a pacemaker.

Orchestra BioMed’s BackBeat Cardiac Neuromodulation Therapy (CNT) was developed to treat hypertension while providing standard pacemaker functions, according to a statement. It reportedly mimics the actions of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone.

In addition to the recent CE mark approval, the company said its MODERATO II clinical study of the BackBeat CNT was selected by the Cardiovascular Research Foundation as late-breaking science for TCT 2019 in San Francisco later this month. The presentation is slated for 12:45 p.m. PST in the convention center’s main arena and will be delivered by Karl-Heinz Kuck, MD, PhD, director of cardiology at the Lans Medicum in Hamburg, Germany.

“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,” Kuck said in the statement. “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 patients’ average baseline ambulatory systolic blood pressure (137 mmHg) was lower compared to patients in other device-based hypertension studies.”