Biomedical company Orchestra BioMed has received European CE-Mark approval for its Moderato implantable pulse generator system to treat patients with hypertension.
Moderato, which comes with standard pacemaker functions, delivers BackBeat cardiac neuromodulation therapy (CNT).
BackBeat CNT is a bioelectronic treatment for an instant chronic lowering of blood pressure (BP). It simultaneously modulates the autonomic nervous system (ANS).
The therapy’s working is similar to multi-drug hypertension treatment. It targets preload, afterload and sympathetic tone, said Orchestra BioMed.
BackBeat CNT could also treat various hypertensive patients, including those with isolated systolic hypertension and people suffering from uncontrolled hypertension even after multi-drug management.
MODERATO II clinical study of cardiac neuromodulation therapy will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference on 28 September in San Francisco, US.
In the previous MODERATO I study, BackBeat CNT yielded positive efficacy and safety results. 78% of the participants had isolated systolic hypertension.
Data showed that patients treated with the device had a lower average baseline ambulatory systolic blood pressure versus those in other device-based hypertension studies.
Orchestra BioMed chairman and CEO David Hochman said: “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.
“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.”
In addition to BackBeat CNT, the company’s portfolio includes Virtue Sirolimus-Eluting Balloon (SEB) to treat artery disease.
In June, Orchestra licensed global development and commercialisation rights for the Virtue SEB to Japan-based Terumo.