Endotronix Cordella PA Sensor System Achieves Excellent One-Year Results

Endotronix Cordella PA Sensor System Shows Promising One-Year Outcomes in Heart Failure Management

NAPERVILLE, Ill., Sept. 28, 2024 /PRNewswire/ -- Endotronix, an Edwards Lifesciences company (NYSE: EW), has released compelling one-year clinical results from the PROACTIVE-HF study, highlighting the effectiveness of the Cordella Pulmonary Artery (PA) Sensor System in managing heart failure (HF). These findings were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting.

The study involved 456 patients and demonstrated a significant reduction in one-year heart failure hospitalization and all-cause mortality rates. Specifically, the results showed 36 events per 100 patients compared to the pre-specified 70 events per 100 patients, marking a 49% decrease.

Additionally, secondary endpoints such as quality of life and biomarker reduction showed marked improvements:

• A 10.5% improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ 5.7 points).
• A 13.3% improvement in the 6-minute walk test (35 meters).
• A 36.2% improvement in the New York Heart Association (NYHA) classification (165 patients).
• A 5.7% reduction in NT-proBNP levels (168 points), a heart failure biomarker.

The safety and efficacy of the Cordella PA Sensor System at 12 months further support the previously published 6-month data, confirming the system's role in improving heart failure outcomes.

"These consistent and compelling data validate that PA pressure-guided therapy enhances heart failure outcomes," said Dr. Liviu Klein, Section Chief of Advanced Heart Failure at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. "The trial results expand our understanding of the impact of comprehensive data, including seated PA pressure and vital signs, in improving outcomes, informing remote medical adjustments, and actively engaging heart failure patients in their care. Clinicians in the trial optimized GDMT and diuretics to reduce PA pressures in congested patients, thereby improving heart function. Unique to Cordella, patients gain visibility into their health data, enhancing their engagement and compliance."

About Endotronix

Endotronix, a subsidiary of Edwards Lifesciences, is at the forefront of medtech and digital health innovation, aiming to enhance care for individuals with heart failure. The Cordella solution offers a proactive, data-driven approach to HF management, engaging patients, preventing congestion, and improving outcomes. The Cordella Sensor, an implantable PA pressure sensor, measures the leading indicator of congestion, facilitating early, targeted therapy. For more information, visit www.endotronix.com.

This release contains forward-looking statements as defined by the Securities Act of 1933 and the Securities Exchange Act of 1934. These statements are covered by safe harbor provisions and include expectations about product benefits, patient outcomes, and other metrics. Forward-looking statements are based on current estimates and assumptions and are inherently uncertain. Endotronix does not undertake any obligation to update these statements. Investors should not unduly rely on forward-looking statements, which involve risks and uncertainties that could cause actual results to differ. For more details, refer to Edwards' SEC filings available at Edwards.com.

Important safety information about Endotronix products is available at www.endotronix.com/risks.

Endotronix, Cordella, and the stylized Endotronix heart logo are trademarks of Endotronix, Inc. Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

SOURCE Endotronix, Inc.