- 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." Dr. Liviu Klein
"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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SOURCE Endotronix, Inc.