Orchestra BioMed, a Pennsylvania-based biomedical innovation company received CE Mark approval for its Moderato implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy (CNT) for treatment of hypertension while also providing standard pacemaker functions.
Hypertension affects 46% American adults. While the conventional therapy for high blood pressure is through drugs, BackBeat allows even existing cardiac implants to deliver treatment in a novel way by modulating the bioelectronic signals associated with blood pressure control.
“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. “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. 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 later this month.”
The company’s MODERATO II clinical study of BackBeat CNT was selected by the the Cardiovascular Research Foundation (CRF) for a late-breaking science presentation at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 annual conference to be held this month. Every year, TCT late-breaking presentations feature major medical research breakthroughs and highlight the latest data on the most innovative treatments that will impact patient care and how physicians treat heart disease. The studies selected examine the safety and efficacy of minimally invasive techniques, pharmaceuticals, therapies and devices that demonstrate potential to treat or prevent cardiovascular disease.
“CE Mark approval and selection for late-breaking science presentation at TCT validate the potential for BackBeat CNT to benefit targeted high-risk hypertensive patients, such as those already indicated for a pacemaker,” said David Hochman, Chairman and CEO of Orchestra BioMed. “Effective treatment of these patients, the majority of whom have isolated systolic disease and persistent high blood pressure despite conventional pharmaceutical therapies, represents a significant market opportunity that could have substantial growth, value and market share implications for the field of cardiac rhythm management.”