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© 2019 Endotronix® Inc.
100469-00 Rev. 2
Introduction
The Cordella™ Pulmonary Artery
(PA) Sensor System is intended to
connect healthcare professionals and patients with tools designed to
improve comprehensive heart failure management. This guide
provides basic information about instructions for use of the Cordella™
Pulmonary Artery Sensor System in the home.
NOTE: The information provided in this patient manual does not
attempt to define any intervention, health care policy, or procedures.
Clinical procedures and policies are the responsibility of your doctor.
Managing Heart Failure with D
aily Cordella™ Sensor
Readings
The Cordella Sensor is designed to provide your care team with
information about the pressure in your PA in order to view and act on
changes in PA pressure or trends over time. The wireless Cordella
Sensor is permanently implanted in a vessel between the heart and
lungs. When you take a measurement, the Cordella Sensor sends a
signal which indicates the pressure in the artery. Changes in PA
pressure may indicate fluid accumulation in the lungs.
By watching the trends in your PA pressure, your healthcare providers
may intervene to address the increasing pressure before you have
symptoms. This information, along with your other vital signs such as
blood pressure, heart rate, blood oxygen, weight and responses to
health-related questions provides your care team with a snapshot of
your health status on the secure website, myCordella Patient
Management Portal (PMP). Based on the trends, your healthcare
provider can manage your heart failure proactively and remotely,
potentially improving your quality of life and preventing
hospitalizations.
Intended Use
The Cordella PA Sensor System is intended to measure, record, and
transmit PA pressure data from NYHA Class III heart failure patients at
home to clinicians for assessment and patient-centered heart failure
management.