Clinical data demonstrate that pulmonary artery (PA) pressure is the best indicator for early detection and proactive care of heart failure decompensation.
FREMONT, CA: Coronary artery diseases, strokes, heart failures, atrial fibrillation, all constitute an infinitesimal portion of cardiovascular anomalies, which remains one of the leading causes of deaths in the United States. As the daunting statistics of human devouring by critical heart diseases elevates, the necessity to program a functional cure by clinical researchers increases.
Dedicated to advance the process of critical heart failure treatment, Endotronix, a synthetic health medical technology provider, initiated enrollment of patients to its multi-centre, SIRONA II trial, in Europe. Following the analytical protocols, sixty patients will be analyzed to assess the safety and efficacy of the Cordella Pulmonary Artery Pressure Sensor System (Cordella Sensor) to promote its CE Mark implementation.
Along the lines of the transformative study, Harry Rowland, Co-founder and CEO of Endotronix, said, “We believe the Cordella System is the right combination of tools for heart failure clinicians to optimize care and improve outcomes for these challenging patients.”
The vulnerability of affecting the immune system solely makes the functionalities of human trails very challenging. Furthermore, with lives in hand, the researchers are continuously backed by an ethical dilemma of whether to lead a specific trial or not. However, the open-label SIRONA II, CE Mark test, is intended to demonstrate the safety and productiveness of the Cordella Sensor for the class III heart failure cases in the New York Heart Association (NYHA).
Cardiologist Prof. Dr. Wilfried Mullens mentioned, “The current treatment model for chronic heart failure is reactive and costly. Clinical data demonstrate that pulmonary artery (PA) pressure is the best indicator for early detection and proactive care of heart failure decompensation. In my experience, the Cordella Sensor provides reliable PA pressure measurements that when combined with daily patient data presents a comprehensive clinical picture so I can effectively manage my heart failure patients remotely.”
Katrin Leadley, MD, Chief Medical Officer of Endotronix said, “SIRONA II builds on the success of our First-in-Human trial and expands our experience with the Cordella Sensor as we progress toward receiving our CE Mark. It is the next step in our robust clinical program, which also includes a pivotal IDE trial for the implantable sensor, PROACTIVE-HF, set to begin later this year in the U.S.”