ONE-YEAR DATA SHOW EXCELLENT OUTCOMES FOR ENDOTRONIX CORDELLA PULMONARY ARTERY SENSOR SYSTEM

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NAPERVILLE, Ill., Sept. 28, 2024 /PRNewswire/ -- Endotronix, an Edwards Lifesciences company (NYSE: EW), today announced the one-year clinical results from PROACTIVE-HF, evaluating outcomes for the Cordella Pulmonary Artery (PA) Sensor System. The data were shared as part of the Heart Failure Society of America (HFSA) Annual Scientific Meeting.

The data demonstrated that the 456 patients managed with Cordella in the study experienced a meaningful reduction in one-year HF hospitalization and all-cause mortality rate (36 events per 100 patients versus the 70 events per 100 patients that were pre specified; 49% lower). 

The study's secondary endpoints of quality of life and biomarker reduction also showed significant improvements:

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

The safety and efficacy results at 12 months further validate the previously published 6-month data.

"These data are consistent and compelling validating that PA pressure-guided therapy improves heart failure outcomes," said Liviu Klein, M.D., Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. "The trial results add to the growing understanding of the impact of comprehensive data – seated PA pressure and vital signs – to further improve outcomes, inform remote medical adjustments and directly engage heart failure patients in their own care. In the trial, clinicians reduced the PA pressures of congested patients by optimizing GDMT and diuretics to improve heart function. And unique to Cordella, patients have visibility to their health data that helps drive their engagement and compliance."

About Endotronix

Endotronix, an Edwards Lifesciences company, innovates at the intersection of medtech and digital health to improve care for people living with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. Learn more at www.endotronix.com.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements contained in this news release are intended to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as "may," "might," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "goal," "continue," "seek," "intend," "optimistic," "aspire," "confident" and other forms of these words and include, but are not limited to, statements made by Dr. Klein and statements regarding expected product benefits, patient outcomes, post-treatment reduction of hospitalizations and mortality rates and improvement of other metrics, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward- looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in Edwards' filings with the Securities and Exchange Commission. These filings, may be found at Edwards.com.

Important safety information about Endotronix products may be found 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.

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