New technology: A pacemaker that lowers blood pressure

A pacemaker for blood pressure control? That sounds amazing. In fact, the device called Moderato™ from Orchestra Biomed is no ordinary Pacemaker . This is a dual-chamber pacemaker, in which, like other devices, a lead is placed in the right atrium and the right ventricle. However, the impulses delivered by the AVIM device differ fundamentally from the signals from other pacemakers.

Moderato's pulses shorten the patient's atrioventricular coupling interval, the time between heartbeats. This gives the left ventricle less time to fill, and the filling volume and thus the ejection volume decrease. Blood pressure drops. Normally, the body responds by activating the sympathetic nervous system, which leads to a compensatory increase in blood pressure. Moderato prevents this by inserting short sequences of one to three heartbeats with a longer coupling interval at irregular intervals.

The effectiveness of the principle was demonstrated in the double-blind, randomized pilot study MODERATO II, the results of which were published in the Journal of the American Heart Association in 2021 (DOI: 10.1161/JAHA.120.020492 ). The application of AVIM technology resulted in patients with previously uncontrolled Hypertension (ambulatory systolic ≥130 mmHg and office systolic ≥140 mmHg despite at least one antihypertensive medication) resulted in a blood pressure reduction of 8.1 mmHg (24-hour ambulatory measurement) and 12.3 mmHg measured in the office. The new technology was described as the "new kid on the block" in an accompanying editorial at the time.

The BACKBEAT registration study is currently underway, and Orchestra Biomed has partnered with the well-known medical device manufacturer Medtronic to further develop Moderato. The Breakthrough Device Designation (BDE) now granted expedited review of the product by the FDA. Orchestra Biomed estimates that more than 7.7 million patients in the United States alone could be eligible for the therapy.