New Hope for Heart Failure Patients: FDA Approves Cordella™ PA Sensor System

An Innovative Approach to Heart Failure Management

Endotronix, a private company focused on innovating heart failure treatment through digital health and med-tech, has received FDA premarket approval for their Cordella™ PA sensor system. This system is designed to help manage heart failure in patients with Class III New York Heart Association (NYHA) classification.

The Cordella platform is unique because it uses daily pulmonary artery (PA) pressure readings and vital signs from home to guide therapy management. This helps healthcare providers make well-informed decisions about the care of their patients between office visits.

How Cordella™ PA Sensor Works

The Cordella system includes an implantable sensor that measures PA pressure and provides this data to physicians remotely. The platform also incorporates easy-to-use, non-invasive health tools for patients to monitor their vital signs daily.

This continuous stream of data allows clinicians to optimize medication dosages and make timely adjustments, significantly improving patient outcomes. The system not only collects data but also engages patients in their care process, helping them develop consistent habits and awareness of their health trends.

Clinical Evidence Supporting Cordella

The approval of the Cordella system was largely based on results from the PROACTIVE-HF clinical trial. The study showed a remarkably low rate of 0.159 for heart failure hospitalization and all-cause mortality at six months among participants using the Cordella system.

Dr. Liviu Klein, the head of the Advanced Heart Failure section at the University of California, San Francisco, stated that the Cordella system provided better clinical pictures and resulted in more timely and optimal dosing of heart failure medications. This, in turn, led to significantly improved outcomes for patients.

Implications for Patient Care

The Cordella system’s ability to provide remote monitoring and manage patients proactively could revolutionize the field of heart failure management. By keeping patients out of the hospital and extending optimal therapeutic management, the system aims to improve the quality of life for heart failure patients.

Harry Rowland, CEO and co-founder of Endotronix, expressed his optimism that this approval will allow the company to provide comprehensive care that will ultimately lead to better patient outcomes.

Future Steps for Endotronix

Endotronix plans to launch the Cordella system in the U.S. by the end of the year. They are also awaiting a decision for European market access in 2025, having already submitted an application for CE Mark review.

The company’s mission is to integrate medical technology and digital health solutions to enhance the care provided to those living with heart failure.

About Endotronix

Endotronix combines med-tech and digital health to deliver a proactive heart failure management solution. The Cordella system is a comprehensive health management platform that integrates data from implantable and non-invasive devices to support both patient engagement and clinical decisions.

This coordinated approach provides valuable insights and trends, aligning with current clinical practices and supporting guideline-based care throughout the heart failure management process.

Regulatory and Market Availability

In the U.S., the Cordella PA sensor system is available by prescription only. In Europe, it is currently available for clinical research purposes. The Cordella HF System is commercially available in both regions.

The FDA's recent approval marks a significant milestone for Endotronix and underscores the potential of innovative technology to drive excellence in home-based patient care.