User Manual

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 Daily 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.