Endotronix gets FDA approval for Cordella PA Sensor System

Endotronix Secures FDA Approval for Cordella Pulmonary Artery Sensor System

Endotronix, a digital health and medtech company, has announced that it has received pre-market approval (PMA) from the US Food and Drug Administration (FDA) for its Cordella Pulmonary Artery (PA) Sensor System. This platform has been specifically designed to monitor and treat New York Heart Failure (NYHA) class III heart failure patients by offering a comprehensive patient management solution. The Cordella platform is unique as it is the only PA pressure-guided platform that utilises daily PA pressure and vital signs to guide therapeutic management and improve patient outcomes.

Transforming Care

The approval of this innovative platform has the potential to transform care for HF patients. Providers are now able to remotely monitor their patients more effectively, thus enabling them to make more informed decisions between appointments. Dr Liviu Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco, and the national principal investigator of the PROACTIVE-HF trial, was extremely positive about the system. He noted that Cordella provides a more complete clinical picture of the patient that allows clinicians to make more informed care decisions when patients are receiving remote care between office visits.

The PROACTIVE-HF Trial Results

The regulatory approval for Cordella was based on the PROACTIVE-HF trial that demonstrated a significant reduction in heart failure hospitalization rates, and lower all-cause mortality rates at six months. According to the data, clinicians using Cordella were able to achieve more optimal and timely dosing of key HF medications, thus improving outcomes. The easy-to-use platform also encourages patients to maintain consistent daily habits and become more aware of trends to support sustainable lifestyle changes.

The Benefits of Cordella

Cordella is a proactive HF management platform that utilises an implantable sensor to deliver vital patient data to a managing HF clinician. Patients can also use non-invasive health tools to share vital data with their clinicians remotely. This recall may also enhance the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. In summary, Cordella has many benefits, which include:

Proactive heart failure management
Daily PA pressure and vital data monitoring
Real-time analytics and decision-making
Higher adherence to GDMT
Reduced hospitalization rates
Lower all-cause mortality rates

Cordella’s Launch

Endotronix plans to launch Cordella in the United States later this year. Additionally, the company has submitted a dossier for CE Mark review and expects a decision on European market access in 2025.

The Future of Healthcare

The approval of Cordella serves as an important milestone for Endotronix and the field of HF management. At Endotronix, the belief is that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure. Heart failure is one of the largest cost categories in healthcare, and this new platform may significantly reduce healthcare costs and improve patient outcomes.

Conclusion

The Cordella Pulmonary Artery Sensor System is a significant breakthrough in the treatment of heart failure patients. With its comprehensive patient management solution, this innovative platform not only reduces hospitalization rates but also decreases all-cause mortality rates. Cordella is a proactive HF management platform that utilises an implantable sensor to deliver vital patient data to a managing HF clinician. Additionally, patients can use non-invasive health tools to share vital data with their clinicians remotely. Cordella’s capabilities offer potential benefits that could transform HF care, keeping patients out of the hospital and allowing them to lead fulfilling lives.

Originally Post From https://www.dicardiology.com/content/endotronix-receives-fda-premarket-approval-cordella-pa-sensor-system-treatment-heart