- Clinical study evaluated impact of AVIM therapy as compared to standard pacing using invasive pressure-volume loop analysis in 16 hypertensive pacemaker-indicated patients
- Results demonstrate statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance and stroke work, with no significant changes in stroke volume or contractility.
- AVIM therapy showed consistent favorable hemodynamic effects using both conduction system pacing, as well as traditional right ventricular lead placements
- Orchestra BioMed is actively enrolling patients in the BACKBEAT pivotal study of AVIM therapy in hypertensive pacemaker patients in collaboration with Medtronic
NEW HOPE, Pa., March 06, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the presentation of new clinical data from a pressure-volume (“PV”) loop study of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™) in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medication. These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations. The PV loop study was conducted at Na Homolce Hospital in Prague by Prof. Petr Neužil, M.D. and the data were featured in an oral presentation at the Technology and Heart Failure Therapeutics (“THT”) 2024 Meeting by Prof. Karl-Heinz Kuck, M.D., Medical Director at LANS Cardio Hamburg.
AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
“These results showcase the innovative mechanism of action of AVIM therapy, which acts through well-characterized physiologic mechanisms to substantially reduce blood pressure and favorably impact circulatory hemodynamics,” commented Professor Kuck. “Well-conducted invasive PV loop studies are a robust way to evaluate the impact of a novel therapy like AVIM on hemodymanics and overall cardiac function. Results from this study in hypertensive pacemaker patients showing significant decreases in systolic blood pressure, intra-cardiac volumes, total peripheral resistance and cardiac workload, without compromising cardiac output or contractility are encouraging and consistent with the therapy’s intended effect. It is also important that these favorable effects occur using both traditional pacing lead locations, as well as conduction system lead positions, which are rapidly emerging as the preferred approach for ventricular pacing given potential benefits to patient safety. These results, in addition to the promising results from prior long-term clinical studies, heighten our excitement about the BACKBEAT global pivotal study that is now underway.”
Summary of the PV Loop Clinical Results Presented at THT 2024
Design
- 16 patients indicated for a dual-chamber pacemaker who also had uncontrolled hypertension despite the use of antihypertensive medication underwent invasive PV loop testing to evaluate cardiac function, measured by changes in left ventricular (“LV”) volumes and pressures using a pressure-volume catheter placed in the LV.
- Systolic blood pressure (“SBP”) was measured using a pressure transducer placed in the aorta, and baseline measurements were recorded using atrial pacing at a fixed rate and normal conduction
- AVIM therapy with pacing leads placed in standard RV locations (“AVIM RV”), as well as in conduction system pacing (“AVIM CSP”) locations targeting the left bundle branch area (LBBA) regions, respectively, was compared to standard AV sequential pacing (DDD mode pacing or “AV Pacing”).
Results Overall mean results for each variable were calculated using paired measurements for each individual patient using AVIM RV, AVIM CSP and AV Pacing, respectively:
- AVIM therapy generated statistically significant reductions (p