Endotronix, Inc. today announced its PROACTIVE-HF pivotal study successfully completed enrollment. Designed to evaluate the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S.
LISLE, Ill., April 4, 2023 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced its PROACTIVE-HF pivotal study successfully completed enrollment. Designed to evaluate the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S. “The PROACTIVE-HF trial is investigating a more comprehensive clinical picture of HF for both clinicians and patients.” “Building upon a strong foundation of evidence in favor of PA pressure-guided therapy, the PROACTIVE-HF trial is investigating a more comprehensive clinical picture for both clinicians and patients,” commented Liviu Klein, MD, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. “Cordella provides daily PA pressure and vital sign data to help clarify patient’s clinical status. Additionally, we are seeing high levels of engagement and lifestyle changes as a result of patients having visibility to their own data. We look forward to sharing the study results in the coming months.” Notably the first global investigational device exemption (IDE) study for PA pressure-guided HF management, PROACTIVE-HF enrolled over 450 patients across the U.S., Ireland, and Belgium. Primary endpoints for the single-arm, multi-center trial include mortality and HF hospitalizations as well as device safety. The company expects to report primary endpoint data from the trial in the first half of 2024. “I would like to congratulate all our clinical partners on their tremendous effort to complete enrollment for PROACTIVE-HF. Their hard work and dedication are key to improving outcomes and expanding patient access, and we appreciate their continued commitment to this trial,” stated Harry Rowland, CEO and co-founder of Endotronix. About Endotronix The Cordella™ PA Pressure Sensor System is an investigational device and is not currently approved for clinical use in any geography. Cautionary Statement Regarding Forward-Looking Statements View original content to download multimedia:https://www.prnewswire.com/news-releases/endotronix-announces-enrollment-completion-of-proactive-hf-pivotal-trial-301789069.html SOURCE Endotronix, Inc. |