- Cordella, which consists of the now PMA-approved Cordella PA
Sensor and commercial Cordella™ HF System, enables comprehensive
heart failure management in the home using pulmonary artery (PA)
pressure, a leading indicator of congestion, and non-invasive vital
sign data to improve care decisions.
- Backed by definitive clinical evidence from
the PROACTIVE-HF pivotal trial, the company is planning a U.S.
launch of Cordella this year.
NAPERVILLE, Ill., June 24, 2024 /PRNewswire/ -- Endotronix, Inc., a
privately held company dedicated to advancing the treatment of
heart failure (HF) at the intersection of digital health and
medtech, today announced Premarket Approval (PMA) from the U.S Food
and Drug Administration (FDA) of the company's Cordella™ Pulmonary
Artery (PA) Sensor System for the treatment of New York Heart
Failure (NYHA) class III heart failure patients. The Cordella
platform is the first and only PA pressure-guided platform to offer
comprehensive patient management using daily PA pressure and vital
signs from home to guide therapeutic management and improve patient
outcomes.
"This approval is very exciting and has the potential to
transform care for HF patients. Endotronix's solution provides a
more complete clinical picture of the patient, so providers are
able to make informed remote care decisions between office visits,"
stated Dr. Liviu Klein, 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. "PROACTIVE-HF
demonstrated that with Cordella clinicians achieved more optimal
and timely dosing of key HF medications, significantly improving
outcomes. In addition, the easy-to-use platform engages patients to
drive consistent daily habits and self-awareness of trends to
support sustainable lifestyle changes."
Cordella is a proactive HF management platform that delivers
daily PA pressure and other vital data via an implantable sensor
and user-friendly, non-invasive health tools, respectively, to a
managing HF clinician for remote patient care. This information
guides clinical decision-making and medication dosing while
enhancing the adoption of guideline-directed medical therapy (GDMT)
to reduce congestion and improve outcomes. Regulatory approval was
based on the PROACTIVE-HF trial, which demonstrated a markedly low
0.159 rate of heart failure hospitalization and all-cause mortality
at 6 months.
In addition, Cordella enables:
- Seated PA pressure measurements, preferred by most patients,
with a handheld reader.
- Patient visibility into key health trends to support healthy
lifestyle changes.
- Secure messaging on a tablet between the clinical team,
patient, and caregiver to support remote care.
- Reimbursement for implantation and ongoing management through
existing reimbursement pathways.
"At Endotronix, we firmly believe that innovation can drive
patient care excellence in the home and ultimately change outcomes
for patients with heart failure, one of the largest cost categories
in healthcare. The FDA's approval validates this foundational
belief and is a major milestone for our company and the field of HF
management," commented Harry
Rowland, CEO and co-founder of Endotronix. "With this
approval, we will deliver proactive, comprehensive care that
extends optimal HF therapeutic management to more patients, keeping
them out of the hospital and living more fulfilling lives."
Endotronix will launch Cordella in the U.S. later this year. The
company also shared that they have submitted a dossier for CE Mark
review and expect a decision on European market access in 2025.
About Endotronix
Endotronix 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. The Cordella HF
System is a patient health management platform, which combines
comprehensive vital sign data from non-invasive devices to support
patient-clinician engagement and care decisions. Combining trended
insights, the versatile and scalable Cordella enhances current
clinical practice and supports guideline-based care across the
entire HF continuum. Learn more at www.endotronix.com.
In the U.S., the Cordella PA Sensor System is Rx Only. CAUTION:
Federal law restricts this device to sale by or on the order of a
physician.
In Europe, the Cordella PA Sensor
System is Exclusively for Clinical Investigation.
The Cordella HF System is commercially available in the U.S. and
Europe.
Cautionary Statement Regarding Forward-Looking
Statements
This press release may contain predictions, estimates, or other
information that might be considered forward-looking statements.
Such forward-looking statements are not a guarantee of future
performance.
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