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

Rhea-AI Summary

Endotronix, an Edwards Lifesciences company (NYSE: EW), announced one-year clinical results from the PROACTIVE-HF trial for the Cordella Pulmonary Artery (PA) Sensor System at the Heart Failure Society of America Annual Scientific Meeting. The study of 456 patients showed a 49% lower rate of heart failure hospitalization and all-cause mortality compared to pre-specified expectations.

Secondary endpoints also demonstrated significant improvements:

• 10.5% in Kansas City Cardiomyopathy Questionnaire
• 13.3% in 6-minute walk test
• 36.2% in New York Heart Association classification
• 5.7% reduction in NT-proBNP levels

These results further validate the previously published 6-month data, supporting the efficacy of PA pressure-guided therapy in improving heart failure outcomes.

Positive

• 49% lower rate of heart failure hospitalization and all-cause mortality
• Significant improvements in quality of life metrics and biomarker reduction
• Validation of previously published 6-month data
• Demonstrated efficacy of PA pressure-guided therapy in improving heart failure outcomes

Negative

• None.

Insights

Medical Research Analyst

The one-year data from the PROACTIVE-HF trial for Endotronix's Cordella Pulmonary Artery Sensor System shows highly promising results for heart failure management. The 49% reduction in heart failure hospitalization and all-cause mortality rate is a significant clinical improvement that could potentially reshape treatment strategies for heart failure patients.

Key secondary endpoints also demonstrated substantial improvements:

• 10.5% increase in quality of life (KCCQ)
• 13.3% improvement in 6-minute walk test
• 36.2% improvement in NYHA classification
• 5.7% reduction in NT-proBNP levels

These results suggest that PA pressure-guided therapy using the Cordella system could lead to better patient outcomes, reduced healthcare costs and improved quality of life for heart failure patients. The data validation at 12 months reinforces the system's long-term efficacy, which is important for chronic disease management.

For Edwards Lifesciences, this successful trial could translate into increased adoption of the Cordella system, potentially driving revenue growth in their heart failure management segment. However, market penetration will depend on factors such as reimbursement policies, physician adoption rates and competition from other heart failure management technologies.

Financial Analyst

The positive clinical results for the Cordella PA Sensor System present a significant opportunity for Edwards Lifesciences (EW) to strengthen its position in the heart failure management market. With a market cap of $40.16 billion, EW has the resources to capitalize on these results through increased marketing and sales efforts.

Key financial implications include:

• Potential revenue growth in the heart failure segment, which could become a major contributor to EW's top line
• Improved market share in the growing remote patient monitoring space
• Possible expansion of profit margins as the technology gains wider adoption

The 49% reduction in hospitalization and mortality rates could translate to significant cost savings for healthcare systems, potentially accelerating adoption and reimbursement approvals. This could lead to a faster-than-expected market penetration, positively impacting EW's financial performance in the coming years.

Investors should monitor upcoming quarterly reports for indications of Cordella's contribution to revenue and any guidance updates reflecting the positive trial results. The long-term growth potential in the heart failure management market could provide a sustainable revenue stream for EW, potentially leading to share price appreciation and increased shareholder value.

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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SOURCE Endotronix, Inc.

FAQ

What were the key findings of the PROACTIVE-HF trial for Edwards Lifesciences' (EW) Cordella PA Sensor System?

The trial showed a 49% lower rate of heart failure hospitalization and all-cause mortality compared to pre-specified expectations. It also demonstrated significant improvements in quality of life metrics and biomarker reduction.

How many patients were involved in the PROACTIVE-HF trial for Edwards Lifesciences' (EW) Cordella System?

The PROACTIVE-HF trial involved 456 patients managed with the Cordella Pulmonary Artery Sensor System.

What secondary endpoints were improved in the Edwards Lifesciences (EW) Cordella System trial?

The trial showed improvements in the Kansas City Cardiomyopathy Questionnaire, 6-minute walk test, New York Heart Association classification, and NT-proBNP levels (a heart failure biomarker).

When were the one-year clinical results for Edwards Lifesciences' (EW) Cordella System announced?

The one-year clinical results for the Cordella Pulmonary Artery Sensor System were announced on September 28, 2024, at the Heart Failure Society of America Annual Scientific Meeting.