Download FOR APPROVAL ONLY, Draft No

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts

Coronary artery disease wikipedia , lookup

Cardiac contractility modulation wikipedia , lookup

Management of acute coronary syndrome wikipedia , lookup

Jatene procedure wikipedia , lookup

Myocardial infarction wikipedia , lookup

Arrhythmogenic right ventricular dysplasia wikipedia , lookup

Cardiac surgery wikipedia , lookup

Atrial fibrillation wikipedia , lookup

Electrocardiography wikipedia , lookup

Quantium Medical Cardiac Output wikipedia , lookup

Heart arrhythmia wikipedia , lookup

Transcript
At CardioNet:
Investor Relations
1.800.908.7103
[email protected]
CardioNet, Inc.
Fact Sheet
Mobile Cardiac Outpatient TelemetryTM:
A New Approach to Identifying Undetected Heart Arrhythmias
Heart Arrhythmias: Common and Potentially Serious
Arrhythmias are disorders of the regular rhythmic beating of the heart. They can occur in a healthy
heart and be of minimal consequence, but they also may indicate a serious problem and lead to
heart disease, stroke or sudden cardiac death.
There are many types of arrhythmias, and they can take many forms. Generally, they are
increasingly frequent as people age. For example, roughly 2.2 million Americans are living with
atrial fibrillation and approximately 9 percent of people over age 80 have this condition. In the
United States, more than 4 million people suffer from recurrent arrhythmias that warrant a
physician’s care. Various diseases and conditions cause arrhythmias, including:






congenital heart defects
congestive heart failure
heart muscle disease
heart valve disorders
other diseases, such as lung conditions
external forces such as electric shock or severe chest injury
Drawbacks of Other Diagnostic Approaches
Delays in arrhythmia diagnoses and treatment often result in increased morbidity, mortality, and
catastrophic medical expenses. But physicians face considerable challenges in diagnosing
arrhythmias. Arrhythmic events may occur infrequently and briefly – in some instances for less
than one minute once or twice a week. In many cases, patients are unaware of arrhythmic events
when they occur.
CardioNet, Inc.
CardioNet MCOT Fact Sheet
Page 2
Current monitors have shortcomings:
 Holter monitors are used for 24 to 48 hours and can only detect an arrhythmia if an event
occurs in that time frame; electrocardiogram (ECG) analysis is done retrospectively.
 Event monitors have limited memory, and usually require the patient to sense and record
the event, and then transmit the data.
 Implanted monitors require a costly, invasive procedure, and an office visit to analyze ECG
data.
 In-hospital patient cardiac telemetry is costly to employ, and does not record patients
during normal daily activity.
Outpatient Telemetry Designed to Meet Patient and Physician Needs
CardioNet’s Mobile Cardiac Outpatient TelemetryTM (MCOTTM) system was developed to address
physicians’ challenges in diagnosing arrhythmias and patients’ need for an easy-to-use automated
system. CardioNet monitors every heartbeat, non-invasively, during the patient’s normal daily
activities, for up to 30 days, and detects, records, and transmits event data automatically to the
prescribing physician.
The system merges patient monitoring technology, wireless communications, and the Internet to
allow targeted cardiac rhythm-related problems to be quickly identified, quantified, and
communicated to the prescribing physician. The physician selects patient-specific monitoring
thresholds and response parameters.
CardioNet’s MCOT system is comprised of a sensor, monitor, and base:
 Patients wear three leads attached to a lightweight sensor worn on a neck strap or belt clip
that continuously transmit two channels of ECG data to the monitor.
 The monitor analyzes the patient’s ECG in real time, heartbeat by heartbeat, at home or
away, as it is transmitted from the sensor. When the monitor identifies an abnormal
rhythm, the data are automatically sent via cell phone or land line to the CardioNet
Monitoring Center for review by a certified monitoring technician. The system does not
require any patient interaction − an important advantage since many arrhythmic events are
symptom-free. However, when patients are symptomatic, they can use the monitor touch
screen to report symptoms and activities, and simultaneously transmit their ECG.
CardioNet, Inc.
CardioNet MCOT Fact Sheet
Page 3
 Whether at home or away, arrhythmic events are transmitted as they occur using the base
and the patient’s normal telephone line, or via an embedded cell phone using wireless
communication.
The CardioNet Monitoring Center reports events, analysis, and symptoms to the physician daily by
fax or via the Internet, according to physician preference. Daily telemetry reports incorporate heart
rate trends and Atrial Fibrillation burden information, sample strips of detected arrhythmias, and
other important diagnostic information. Urgent telemetry reports are sent to the physician
immediately when critical events occur, and when directed, the CardioNet Monitoring Center helps
arrange emergency medical services.
CardioNet also provides an in-service specialist who assists the physician’s staff on the correct
procedure to enroll patients, and a patient educator who instructs patients on the
system’s use.
Patient Indications for MCOT Monitoring
In February 2002, CardioNet received U.S. Food and Drug Administration marketing clearance for
the CardioNet MCOT system. Indications for use include patients:









Demonstrating a need for cardiac monitoring and are at low risk of developing primary
ventricular fibrillation or sustained ventricular tachycardia
With dizziness or lightheadedness
With palpitations
With syncope (fainting) of unknown etiology
Requiring monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other
supra-ventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent
bundle branch block. This includes postoperative monitoring for these rhythms
Recovering from coronary artery bypass graft (CABG) surgery who require monitoring for
arrhythmias
Requiring monitoring for arrhythmias inducing co-morbid conditions such as
hyperthyroidism or chronic lung disease
With obstructive sleep apnea to evaluate possible nocturnal arrhythmias
Requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia,
possibly secondary to atrial fibrillation
The complete list of indications and contraindications is available in the Medical Professionals
section of the CardioNet Web site at www.cardionet.com.
CardioNet, Inc.
CardioNet MCOT Fact Sheet
Page 4
###