Use Instructions

Instructions For Use | 98 | © 2018 Endotronix Inc.
100474-00 Rev 1
2. Device Descriptions
The Cordella Pulmonary Artery Sensor System measures pulmonary artery
(PA) pressure on demand to help clinicians identify pulmonary congestion
suggestive of worsening heart failure through evaluation of trends of
pulmonary artery pressure values. The Cordella PA Sensor System consists
of a catheter-based Delivery System with a pre-loaded Cordella PA Sensor
(Cordella Sensor), Calibration Equipment (CalEQ), a Reader that allows
patients to measure PA pressure at home, and Cordella Data Analysis
Platform (CDAP), a cloud-based platform to store and analyse the PA
pressure measurements.
2.1 Cordella™ PA Sensor
The Cordella Sensor is a small implant that resides permanently in
the patient’s pulmonary artery. The Cordella Sensor does not contain
batteries or active electrical components.
2.2 myCordella Patient Reader
The myCordella Patient Reader (Reader) is
a handheld device that is provided to the
patient for at-home use to measure PA
pressure on demand. The Reader wirelessly
transmits the raw data obtained from the
Cordella Sensor to the myCordella Hub.
The raw data is converted into readable
data and sent to the myCordella Patient
Management Portal for the clinician to
review.
2.3 Delivery System
The Delivery System is a catheter with a pre-loaded Cordella Sensor at the
distal end and is used to implant the Cordella Sensor into the pulmonary
artery. The Delivery System is comprised of a stability sheath, torque
catheter, torque catheter handle, torque luer, and side port. Implantation
of the Cordella Sensor using the Delivery System is designed to be
performed during right heart catheterization through venous access.
The Cordella Sensor and Delivery System are packaged together and
sterilized with ethylene oxide before shipment. The Delivery System is
designed for single use and should not be reused or re-sterilized. If the
sterile package has been compromised, do not use the Cordella Sensor
and Delivery System, and contact Customer Support.
2.4 Calibration Equipment
The Calibration Equipment (CalEQ) is
hospital equipment that supports the
implantation procedure.
• Facilitates linking of component serial
numbers to patient IDs.
• Calibrates the Cordella Sensor to a reference
pressure at the time of implantation.
• Interrogates the Cordella Sensor to verify
proper working condition.
• Trains patient on optimal Reader placement
post-procedure.
2.5 Cordella Data Analysis Platform (CDAP)
The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based,
standalone application that collects and stores raw Reader data and
processes it according to pre-defined algorithms to convert it into final-
form pulmonary artery pressure data.