The study will lead to the enhancement of HF patient care at their homes, eliminating the need for clinician visits.
FREMONT, CA: Health monitoring technology is changing the healthcare sector, taking personalized care to the doorstep of patients. It has transformed the lives of heart patients, eliminating the need for regular interactions with the clinicians. One of the organizations spearheading this revolution is Endotronix.
The digital health and medical technology company recently received conditional investigational device exemption (IDE) approval from the FDA, which allows it to begin the multi-center PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor).
Endotronix aims to augment the treatment of heart failure (HF) with its offerings. The company delivers an integrated platform designed to provide comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. The Cordella Heart Failure System comprises a cloud-based disease management data system and at-home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure.
The innovative trial will expedite pre-market approval (PMA) of the Cordella Sensor and provide evidence to inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS). The company plans to begin the trial enrollments in the third quarter of 2019.
The groundbreaking trial will potentially deliver the highest level of clinical evidence needed to redefine the standard of care for chronic heart failure patients. The trial design and treatment guidelines are designed to proactively lessen patient PA pressures and empower physicians to maintain target pressures, which will likely reduce patient mortality and lower the rate of HF-related hospitalization.
The PROACTIVE-HF is a prospective, multi-center, randomized, and controlled trial developed to evaluate the efficacy and safety of the Cordella Sensor in more than 950 patients at over 60 sites across the United States. The trial will assess the potential benefits of PA pressure-guided management with Cordella Sensor for New York Heart Association (NYHA) Class III heart failure patients.
The primary endpoints will assess device safety, mortality rate, HF hospitalization, and the use of IV diuretics at 12 months. The secondary parameters of the trial comprise a change in PA pressure, HF medication changes, device performance, and patient quality of life.
The Cordella Sensor is integrated with Cordella Heart Failure System (Cordella System), which is designed to deliver a complete health status of the patient at home with a remote patient management platform and simplified tools to securely collect and exchange daily patient data with the relevant physicians and clinicians.
The Cordella System and Cordella Sensor will proactively deliver the essential information to enhance patient care between office visits, while at the same time, bolstering reimbursement for care delivery activities. The system offers remote titration of medication and streamlines patient management to assist the patients in their home.
The FDA approval for the trial is a crucial victory for the company, and the patients suffering from heart conditions. PROACTIVE-HF is designed to exhibit an ultimate benefit for PA pressure-guided management and deliver the information required for reimbursement. The study, combined with SIRONA II, will bolster the clinical foundation for Cordella Sensor and Cordella System for market adoption. The Cordella Sensor is currently not available for commercial use since it is an investigational device.