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– Endotronix submits a marketing authorization application for its Cordella pulmonary artery sensor system
NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the filing of an application of premarket approval (PMA) for its Cordella™ pulmonary artery (PA) sensor system to the US Food and Drug Administration (FDA).
Cordella is an innovative heart failure patient management platform that provides proactive blood pressure data and non-invasive vital data for comprehensive heart failure management at home. Its easy-to-use devices securely transmit daily health information to the treating physician, enabling optimal dosing of guideline-guided medical therapy (GDMT) to reduce congestion and engage patients with health trend data. so they can choose a healthy lifestyle.
“A cornerstone for the treatment of patients with NYHA class III heart failure, PA pressure-guided therapy combined with strong patient engagement and integration of daily vital signs is an exciting advancement that has the potential to improve outcomes,” said Harry Rowland, CEO and co-founder of Endotronix. “The submission of this PMA application is an important regulatory milestone and brings us one step closer to the planned commercial launch of the Cordella sensor in the second half of this year.”
This news follows the company’s previous announcement that PROACTIVE-HF, the company’s 450-patient investigational device exemption (IDE) trial, has completed enrollment. The company expects to present primary results of the trial in the first half of 2024.
About Endotronix
Endotronix 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 available at www.endotronix.com.
The Cordella Pulmonary Artery Sensing 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.
Caution Regarding Forward-Looking Statements
This press release may contain predictions, estimates or other information that could be considered forward-looking. Such forecasts do not guarantee future results.
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