Endotronix, a company dedicated to advancing heart failure treatment through digital health and medtech innovations, has received pre-market approval (PMA) from the FDA for its Cordella™ pulmonary artery (PA) sensor system.

This approval targets patients with New York Heart Association (NYHA) class III heart failure. Cordella is the first PA pressure-guided platform integrating daily PA pressure and vital sign monitoring from home, aiming to enhance therapeutic management and improve outcomes.

Head of Advanced Heart Failure Service at the University of California, San Francisco, and national principal investigator of the PROACTIVE-HF trial, expressed enthusiasm about Cordella's potential impact.

The PROACTIVE-HF study demonstrated significant improvements, including optimized medication dosing and reduced heart failure hospitalizations and mortality rates.

Cordella facilitates remote patient care by delivering daily vital data through an implantable sensor and intuitive health tools.

It supports clinical decision-making, promotes guided medical therapy (GDMT), and encourages healthier habits based on patient health trends.

Secure tablet-based messaging facilitates communication among the clinical team, patients, and caregivers to support remote care.

CEO and co-founder of Endotronix, highlighted Cordella's transformative potential in heart failure management and patient outcomes.

The FDA approval marks a significant milestone for the company, paving the way for broader implementation and positively impacting healthcare costs associated with heart failure.

Endotronix plans to launch Cordella in the United States later this year and has submitted it for CE marking review, aiming for access to the European market by 2025.

 

 

 

 

 

 

Source: prnewswire.com

Report Abuse