NAPERVILLE, Ill., Oct. 9, 2023/PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), has announced that it has received approval for FDA Investigational Device Exemption (IDE) for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella sensor for pulmonary artery (PA) pressure-guided therapy. The goal of this prospective double-arm trial is to expand access to patients with New York Heart Association (NYHA) class II HF and facilitate effective and scalable remote patient management using a patient-directed self-management strategy. doctor.
“The evidence in favor of pressure-guided treatment of PA in patients with NYHA class III HF has been systematically validated over the past 15 years. However, questions remain about the benefit of treatment in NYHA class II patients.” NYHA and how best to scale effective HF treatment remotely,” said Dr. Lynne W. Stevenson, a heart failure specialist at Vanderbilt University Medical Center in Nashville, TN, and global principal investigator (PI ) of the PROACTIVE-HF 2 clinical trial. “The randomized arm of PROACTIVE-HF 2 will be the first study to compare AP pressure-guided treatment with a telehealth control arm. The single-arm cohort evaluates the power of the compromised patients and the subsequent impact on outcomes. Together, these studies help us better understand the impact of pulmonary hypertension on right ventricular function over time and provide guidance on how to scale up this important therapy with the participation of patients.”
The prospective, open-label, randomized, controlled PROACTIVE-HF 2 clinical trial will enroll up to 1,500 patients in the US and Europe. The double-arm study design was presented over the weekend at the HFSA and the first patient is expected to enroll later this year. The randomized arm will evaluate the safety and efficacy of pressure-guided treatment of the PA with Cordella in NYHA class II patients at risk for congestion. In both cohorts, patients and physicians will have access to daily trending telehealth data (i.e., blood pressure, heart rate, and weight) and the treatment cohort will also have access to daily AP pressure data. The study will evaluate safety and effectiveness, using a composite rate of first HF event or death, for up to 24 months. The single-arm study will evaluate the impact of physician-led patient self-management at home in patients with NYHA class III HF who are at risk for poor outcomes using a 12-month endpoint for safety and the incidence of hospitalization or death due to HF. Both arms will collect data on secondary endpoints, including changes in right ventricular function in relation to PA pressure and patient engagement.
Additionally, the company presented 12-month substudy data from its initial PROACTIVE-HF pivotal trial at the HFSA conference, demonstrating a low HF hospitalization rate of 0.34 at 12 months in patients with NYHA class III HF. . In December 2021, the pivotal, prospective, multicenter PROACTIVE-HF trial was redesigned from a randomized controlled trial, with patients and providers in a control arm blinded to BP values, to a single study. arm in which both groups had access to patient data. Data from 63 patients in the former control arm were evaluated before and during the 12-month period after unblinding, demonstrating significant improvements in mean AP pressure (mPAP) and outcomes, as well as a great interest from patients in having access to PA pressure data.
These data coincide with the announcement that the PROACTIVE-HF study has completed its primary endpoint follow-up period and data are being prepared for premarket approval (PMA) submission to the FDA at the end of the year. and the presentation of the data in the first half of next year.
“We are establishing a strong foundation of compelling clinical evidence for Cordella with the first data from PROACTIVE-HF. The team is moving toward PMA submission before the end of this year and hopes to share results from the full study cohort in 2024” said Harry Rowland, CEO and co-founder of Endotronix. “We remain confident in the benefits Cordella brings to patients and physicians to improve heart failure outcomes and remain on track to launch in mid-2024.”
About EndotronixEndotronix innovates at the intersection of medical technology and digital health to improve care for people with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the main indicator of congestion, allowing for early and specific treatment. The Cordella HF system is a patient health management platform that combines comprehensive vital signs data from non-invasive devices to facilitate patient and physician engagement in care decision making. Combining trend information, the versatile and scalable Cordella improves current clinical practice and supports guideline-based care throughout the entire HF continuum. More information at www.endotronix.com.
The Cordella PA Pressure Sensor System is an investigational device and is not currently approved for clinical use in any geography. CAUTION – Investigational device. Limited by Federal (or United States) Law to research use. For clinical research only. The Cordella HF system, without the sensor, is available for commercial use in the US and EU.
Cautions Regarding Forward-Looking Statements
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