A Pacemaker to Control BP
A Pacemaker to Control BP:
New therapy targeting uncontrolled hypertension using a pacemaker!.
Medscape. April 23 ,2025.
Atrioventricular interval modulation (AVIM) therapy designed to provide immediate relief to patients with uncontrolled hypertension.
Article Summary:
1. FDA Breakthrough Designation: The US FDA granted Breakthrough Device Designation to Orchestra BioMed for its new therapy targeting uncontrolled hypertension using a pacemaker.
2. What is AVIM?: The therapy, called AVIM (Atrioventricular Interval Modulation) delivered through dual-chamber pacemakers, modulates AV interval & heart rhythm to lower blood pressure and influence the autonomic nervous system.modulate the autonomic nervous system.
3. Target Patients: For the time being AVIM is designed for high risk patients with uncontrolled hypertension especially those who don’t respond well to or can’t tolerate antihypertensive medications.
4. Estimated Population: Over 7.7 million patients in the US may be eligible for this therapy, according to Orchestra BioMed.
5. Clinical Evidence: A clinical trial (MODERATO II) showed significant reductions in both ambulatory and office systolic blood pressure.
6. Ongoing Trial:
A larger trial (BACKBEAT), in partnership with Medtronic, is ongoing.
The manufacturer aims to expand AVIM beyond pacemaker patients, offering a consistent, device-based alternative to daily medications!.
7. Future Vision: The company plans to expand AVIM use beyond pacemaker-indicated patients, offering it as a device-based, always-on, programmable therapy that doesn’t rely on daily medication adherence.https://www.medscape.com/viewarticle/pacemaker-control-bp-gets-fda-breakthrough-designation-2025a10009t3
