Saturday, July 13, 2024

Heart Failure Treatment Advanced with FDA Approval of Endotronix’s Cordella Pulmonary Artery Sensor System

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Heart failure patients with New York Heart Failure (NYHA) class III have a new treatment option as the Food and Drug Administration (FDA) has granted Premarket Approval (PMA) to Endotronix’s Cordella Pulmonary Artery (PA) Sensor System. This approval signifies a significant advancement in heart failure management, marking the first PA pressure-guided platform designed for home-based comprehensive heart failure care.

The device provides daily PA pressure readings from an implanted sensor, along with non-invasive vitals such as blood pressure, heart rate, and weight, offering a complete clinical picture for remote care decisions.

Heart Failure Treatment Advances: FDA Approval of Cordella PA Sensor System Based on PROACTIVE-HF Trial Data

The approval of the Cordella PA Sensor System is based on data from the multi-center, prospective PROACTIVE-HF trial, which involved 528 NYHA class III heart failure patients across 75 sites in the United States and Europe. The trial achieved its primary safety and efficacy endpoints, along with several secondary endpoints.

Key findings from the trial include a significantly low rate of hospitalization (0.159) due to heart failure and all-cause mortality at the six-month mark. Additional results demonstrated a 23-meter improvement in a six-minute walk test, improvement in NYHA classification for 144 patients, an average weight decrease of 2.2 lbs, a 5.9 mmHg reduction in in-office systolic blood pressure from baseline, and a 2.4 mmHg decrease in seated mean PA pressure from baseline for congested patients.

Dr. Liviu Klein, national trial principal investigator and section chief of advanced heart failure, mechanical circulatory support, pulmonary hypertension, and heart transplant at the University of California San Francisco, expressed enthusiasm about the potential of the Cordella system to transform care for heart failure patients. “This approval is very exciting and has the potential to transform care for HF patients.

Heart Failure

Heart Failure Management Enhanced: Endotronix’s Cordella System Improves Clinical Decision-Making and Patient Outcomes

Endotronix’s solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits,” said Dr. Klein. He noted that the PROACTIVE-HF trial demonstrated that with Cordella, clinicians achieved more optimal and timely dosing of key heart failure medications, significantly improving patient outcomes. Additionally, the user-friendly platform encourages patients to maintain consistent daily habits and awareness of health trends, supporting sustainable lifestyle changes.

Harry Rowland, CEO and co-founder of Endotronix, highlighted the years of hard work and dedication that led to this approval. “These results are the culmination of many years of hard work and dedication by the Endotronix team and our clinical partners as we strive to provide best-in-class care for heart failure patients,” Rowland stated. He emphasized that proactive, comprehensive care with Cordella improves the lives of heart failure patients and that the PROACTIVE-HF trial provides compelling evidence to support this innovative approach to remote care delivery. With the commercial launch expected later this year, Endotronix aims to support clinicians in helping heart failure patients lead more full and active lives.

The Cordella system allows for seated PA pressure measurements using a handheld reader, providing patients visibility into key health trends to support healthy lifestyle changes. It also facilitates secure messaging between clinical teams, patients, and caregivers via a tablet, and offers implantation reimbursement. The device is expected to launch in the United States later this year, with submissions for CE Mark review in Europe underway. A decision on European market access is anticipated next year.

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The FDA’s approval of Endotronix’s Cordella PA Sensor System represents a major milestone in heart failure management. “At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA’s approval validates this foundational belief and is a major milestone for our company and the field of HF management,” said Rowland. With this approval, Endotronix is poised to deliver proactive, comprehensive care that extends optimal heart failure therapeutic management to more patients, helping to keep them out of the hospital and living more fulfilling lives.

The Cordella PA Sensor System’s ability to provide detailed daily PA pressure readings and non-invasive vital sign monitoring sets a new standard in heart failure management, offering both patients and healthcare providers a powerful tool for improving treatment outcomes and enhancing quality of life. As Endotronix moves forward with its commercial launch, the healthcare community eagerly anticipates the positive impact this innovative system will have on heart failure care.

 

Resource: PR Newswire, June 25, 2024

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