Endotronix, an Illinois-based healthcare technology company focused on developing heart failure treatments, gained an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) for its Cordella Sensor for hemodynamic monitoring to be the focus of a new clinical trial, the PROACTIVE-HF 2 study.
The Cordella Sensor was designed for pulmonary artery (PA) pressure-guided therapy. The PROACTIVE-HF 2 study is designed to examine the device’s safety and effectiveness among patients presenting with New York Heart Association (NYHA) class II heart failure. As many as 1,500 patients from the United States and Europe will be enrolled.
“The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years,” Lynne W. Stevenson, MD, a heart failure specialist with Vanderbilt University Medical Center and global principal investigator of PROACTIVE-HF 2, said in a prepared statement. “However, questions remain as to the therapy benefit in NYHA class II patients and how to best scale effective remote HF management. The randomized arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm. The single-arm cohort evaluates the power of engaged patients and subsequent impact on outcomes.”
In related news, new 12-month data from the original PROACTIVE-HF clinical trial was presented at the Heart Failure Society of America’s annual meeting in Cleveland. Based on early data, the Cordella Sensor was associated with a heart failure hospitalization rate of 0.34 after 12 months among patients with NYHA class III heart failure. In addition, 78% of patients went on to make lifestyle changes after treatment. Eighty-six percent of patients said PA pressure management made a “positive impact” on their health.
According to Endotronix, this 12-month data will be part of the company’s pre-market approval submission to the FDA later this year. Data will be presented to the public in early 2024.
“We remain confident in the benefits Cordella brings to patients and clinicians to improve heart failure outcomes and remain on track for a mid-2024 launch,” Harry Rowland, CEO and co-founder of Endotronix, said in the same statement.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.