ONE-YEAR DATA SHOW EXCELLENT OUTCOMES FOR ENDOTRONIX CORDELLA PULMONARY ARTERY SENSOR SYSTEM
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.
Endotronix, una compagnia di Edwards Lifesciences (NYSE: EW), ha annunciato i risultati clinici a un anno dello studio PROACTIVE-HF per il sistema di sensori dell'arteria polmonare (PA) Cordella durante il Congresso Scientifico Annuale della Heart Failure Society of America. Lo studio su 456 pazienti ha mostrato un 49% in meno di ricoveri per insufficienza cardiaca e mortalità per tutte le cause rispetto alle aspettative predefinite.
Gli endpoint secondari hanno anche dimostrato miglioramenti significativi:
- 10.5% nel Kansas City Cardiomyopathy Questionnaire
- 13.3% nel test di camminata di 6 minuti
- 36.2% nella classificazione della New York Heart Association
- 5.7% di riduzione nei livelli di NT-proBNP
Questi risultati convalidano ulteriormente i dati a 6 mesi precedentemente pubblicati, supportando l'efficacia della terapia guidata dalla pressione dell'arteria polmonare nel miglioramento degli esiti dell'insufficienza cardiaca.
Endotronix, una compañía de Edwards Lifesciences (NYSE: EW), anunció los resultados clínicos de un año del ensayo PROACTIVE-HF para el Sistema de Sensor de Arteria Pulmonar (PA) Cordella durante la Reunión Científica Anual de la Sociedad de Insuficiencia Cardíaca de América. El estudio que incluyó 456 pacientes mostró una reducción del 49% en las hospitalizaciones por insuficiencia cardiaca y mortalidad por todas las causas en comparación con las expectativas predefinidas.
Los puntos finales secundarios también demostraron mejoras significativas:
- 10.5% en el Cuestionario de Cardiomiopatía de Kansas City
- 13.3% en la prueba de caminar de 6 minutos
- 36.2% en la clasificación de la Asociación Americana del Corazón de Nueva York
- 5.7% de reducción en los niveles de NT-proBNP
Estos resultados validan aún más los datos publicados previamente a los 6 meses, apoyando la eficacia de la terapia guiada por la presión de la arteria pulmonar para mejorar los resultados de la insuficiencia cardíaca.
엔드로토닉스(Endotronix)는 에드워즈 라이프사이언스(Edwards Lifesciences) 회사(NYSE: EW)로서, 하트 페일러 소사이어티 오브 아메리카 연례 과학 회의에서 코르델라 폐동맥(PA) 센서 시스템에 대한 PROACTIVE-HF 시험의 1년 임상 결과를 발표했습니다. 456명의 환자를 대상으로 한 연구 결과, 49% 감소한 심부전 입원율과 전원인 사망률을 사전 지정된 기대치와 비교하여 보여주었습니다.
2차 최종 지표는 또한 중요한 개선을 보여주었습니다:
- 캔자스 시티 심근병증 설문지에서 10.5%
- 6분 걷기 테스트에서 13.3%
- 뉴욕 심장협회 분류에서 36.2%
- NT-proBNP 수치에서 5.7% 감소
이 결과는 이전에 발표된 6개월 데이터를 추가로 검증하며, 심부전 결과 개선을 위한 PA 압력 유도 치료의 효과를 지지합니다.
Endotronix, une société de Edwards Lifesciences (NYSE: EW), a annoncé les résultats cliniques d'un an de l'essai PROACTIVE-HF pour le Système de capteur de l'artère pulmonaire (PA) Cordella lors de la réunion scientifique annuelle de la Heart Failure Society of America. L'étude portant sur 456 patients a montré un taux d'hospitalisation pour insuffisance cardiaque réduit de 49% et une mortalité toutes causes confondues par rapport aux attentes prédéfinies.
Les critères secondaires ont également montré des améliorations significatives :
- 10,5 % dans le Kansas City Cardiomyopathy Questionnaire
- 13,3 % dans le test de marche de 6 minutes
- 36,2 % dans la classification de l'Association cardiaque de New York
- 5,7 % de réduction des niveaux de NT-proBNP
Ces résultats valident davantage les données à 6 mois précédemment publiées, soutenant l'efficacité de la thérapie guidée par la pression de l'artère pulmonaire pour améliorer les résultats de l'insuffisance cardiaque.
Endotronix, ein Unternehmen von Edwards Lifesciences (NYSE: EW), hat die klinischen Ergebnisse nach einem Jahr der PROACTIVE-HF-Studie zum Cordella Pulmonary Artery (PA) Sensor System auf der Jahrestagung der Heart Failure Society of America bekannt gegeben. Die Studie mit 456 Patienten zeigte eine 49% niedrigere Rate an Krankenhausaufenthalten aufgrund von Herzinsuffizienz und einer allzeitigen Sterblichkeit im Vergleich zu den vorher festgelegten Erwartungen.
Die sekundären Endpunkte zeigten ebenfalls signifikante Verbesserungen:
- 10,5% im Kansas City Cardiomyopathy Questionnaire
- 13,3% im 6-Minuten-Gehtest
- 36,2% in der Klassifikation der New York Heart Association
- 5,7% Rückgang der NT-proBNP-Werte
Diese Ergebnisse bestätigen weiter die zuvor veröffentlichten 6-Monats-Daten und unterstützen die Wirksamkeit der PA-Druckgeleiteten Therapie zur Verbesserung der Ergebnisse bei Herzinsuffizienz.
- 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
- None.
Insights
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 test36.2% improvement in NYHA classification5.7% 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.
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
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
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.
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;
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
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