BaroPace has obtained approval from India’s Central Drugs Standard Control Organisation (CDSCO) for its first-in-human clinical study with the patent-pending real-time closed-loop system, PressurePace.
PressurePace is still an investigational device and has not received approval for commercial use in any geographical region.
Called RelieveHFpEF-II, the study will assess the real-time closed-loop system for regulating a cardiac pacemaker to improve exercise tolerance, sense of well-being and blood pressure control in heart failure patients with preserved ejection fraction (HFpEF) associated with hypertension.
This month, the company intends to begin the first patient enrollment in this cross-over design, randomised and early feasibility study.
It is claimed to be the first study assessing the real-time closed-loop pacemaker regulation system based on the input of blood pressure and the capability for patient interaction with the closed loop in real-time for better treatment.
The trial is also aimed at demonstrating the safety and efficacy of real-time remote pacemaker programming.
A clinical trial-stage medical device company, BaroPace develops real-time closed-loop cardiac pacemaker control systems for the treatment of drug-resistant hypertension and heart failure with preserved ejection fraction.
BaroPace founder and CEO Michael Burnam said: “The relationship between heart rate and blood pressure has been known for 200 years but, until now, pacemakers have been blind to it and other important physiologic parameters.
“The ability to regulate pacemakers in real-time based on blood pressure and the patient’s real-time, symptom-based input could usher in a new age of automated implantable cardiac device control.”
