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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