ONE-YEAR DATA SHOW EXCELLENT OUTCOMES FOR ENDOTRONIX CORDELLA PULMONARY ARTERY SENSOR SYSTEM USA - English USA - English
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NAPERVILLE, Ill., Sept. 28, 2024 ~ Endotronix, a subsidiary of Edwards Lifesciences (NYSE: EW), has released the one-year clinical results from their PROACTIVE-HF study at the Heart Failure Society of America (HFSA) Annual Scientific Meeting. The study evaluated the outcomes of using the Cordella Pulmonary Artery (PA) Sensor System in managing heart failure.

The data from the study showed that out of the 456 patients who were managed with Cordella, there was a significant reduction in one-year hospitalizations and all-cause mortality rate. This was compared to the pre-specified rate of 70 events per 100 patients, with only 36 events per 100 patients being reported in the study. This represents a 49% decrease in hospitalizations and mortality.

In addition to these primary endpoints, the study also looked at secondary endpoints such as quality of life and biomarker reduction. The results showed significant improvements in these areas as well. Patients experienced a 10.5% increase in their Kansas City Cardiomyopathy Questionnaire score, a 13.3% improvement in their 6-minute walk test distance, and a 36.2% decrease in New York Heart Association classification. There was also a 5.7% reduction in NT-proBNP levels, which is a biomarker for heart failure.

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These findings further validate the previously published six-month data on the safety and efficacy of using Cordella for managing heart failure.

Dr. Liviu Klein, Section Chief of Advanced Heart Failure at the University of California San Francisco and national principal investigator of PROACTIVE-HF trial, commented on these results saying, "These data are consistent and compelling validating that PA pressure-guided therapy improves heart failure outcomes." He also noted that this trial adds to our understanding of how comprehensive data can improve outcomes by allowing for remote medical adjustments and engaging patients in their own care.

The study showed that by optimizing guideline-directed medical therapy and diuretics, clinicians were able to reduce PA pressures in congested patients, leading to improved heart function. One unique aspect of Cordella is that it provides patients with visibility into their health data, which can help drive their engagement and compliance with treatment.

Endotronix, which was acquired by Edwards Lifesciences, focuses on the intersection of medical technology and digital health to improve care for heart failure patients. Their comprehensive Cordella solution allows for proactive and data-driven management of heart failure, leading to better outcomes. The Cordella Sensor is an implantable device that directly measures PA pressure, a key indicator of congestion in heart failure patients.

To learn more about Endotronix and their innovative solutions for managing heart failure, visit www.endotronix.com.

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