NEW HOPE, PA — In an ongoing endeavor to combat hypertension, Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has unveiled the latest results from a pressure-volume (PV) loop study of its novel Atrioventricular Interval Modulation (AVIM) therapy, also known as BackBeat CNT™.
Performed at Na Homolce Hospital, Prague, the study shows the potential of AVIM therapy to effectively reduce systolic blood pressure and enhance overall cardiac function in patients with a pacemaker who are struggling with uncontrolled hypertension despite taking antihypertensive medication.
The innovative therapy employs a standard dual-chamber pacemaker to deliver immediate, substantial, and persistent blood pressure reduction. Its effectiveness draws from well-understood physiological mechanisms to drive tangible improvements in circulatory hemodynamics.
Professor Karl-Heinz Kuck, Medical Director at LANS Cardio Hamburg, who presented the findings at the recent Technology and Heart Failure Therapeutics (THT) 2024 Meeting, hailed the therapy’s innovative action mechanism. He emphasized the potential of AVIM to reduce intra-cardiac volumes, total peripheral resistance, and cardiac workload, all while maintaining cardiac output and contractility.
The study recruited 16 patients with uncontrolled hypertension despite taking antihypertensive medication, all of whom were in need of a dual-chamber pacemaker. The results of the PV loop testing indicated a significant decrease in systolic blood pressure, end diastolic volume, end diastolic pressure, and end systolic volume. The benefits were observed across both traditional pacing lead locations and conduction system lead positions.
Orchestra BioMed’s collaboration with Medtronic plc (NYSE: MDT) reflects the market’s growing interest in AVIM therapy. Should the U.S. Food and Drug Administration approve AVIM, Medtronic will gain exclusive rights to commercialize AVIM-enabled pacing systems, leading to increased revenues for both companies.
As of now, Orchestra BioMed is diligently enrolling patients in the BACKBEAT global pivotal study. This prospective, randomized, double-blind study is examining the efficacy and safety of AVIM therapy among patients recently fitted with a Medtronic dual-chamber cardiac pacemaker who still have uncontrolled hypertension. The prime efficacy endpoint of the study will ascertain whether AVIM can achieve a significant reduction in systolic blood pressure after three months compared to control patients.
Orchestra BioMed continues to innovate in the healthcare field and is gaining increasing attention among industry watchers for its pioneering work.
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