Itamar Medical Ltd.
Endo
PAT
TM
x Device
1
Operation Manual
1
General Information
This operation manual is part of the EndoPAT
TM
x system.
1.1
Intended Use of the EndoPAT
TM
x Device
The EndoPAT
TM
x device is a non-invasive device, intended for use as a diagnostic aid in the
detection of coronary artery Endothelial Dysfunction (positive or negative) using a reactive
hyperemia procedure.
The EndoPAT
TM
x Device has been shown to be predictive of coronary artery Endothelial
Dysfunction in the following patient population: patients with signs or symptoms of ischemic
heart disease, who are indicated for coronary artery angiography, but who lack angiographic
evidence of obstructive coronary artery disease. The device is intended to be used in a
hospital or clinic environment by competent health professionals
The EndoPAT
TM
x device is not intended for use as a screening test in the general patient
population. It is intended to supplement, not substitute, the physician’s decision-making
process. It should be used in conjunction with knowledge of the patient’s history and other
clinical findings.
1.2
Performance and clinical study information
Note
EndoPAT™x is the successor of EndoPAT™2000, the
currently available device, with the same intended use, same
functionality and equivalent performance. The information
below is based on EndoPAT™2000 results.
The following sensitivity and specificity data were revealed from a clinical study that was
performed at the Mayo Clinic Rochester, MN and that had been designed to evaluate the
safety and effectiveness of the EndoPAT
TM
2000 device as an aiding tool in the diagnosis of
coronary artery Endothelial Dysfunction versus a Gold Standard for coronary Endothelial
Dysfunction evaluation, the Intra-coronary Acetylcholine (Ach) Challenge method:
All subjects: Sensitivity = 82% (45/55), 95% lower confidence bound = 71%
Specificity = 77% (30/39), 95% lower confidence bound = 63%
________________________________________________________________
Females:
Sensitivity = 91% (30/33), 95% lower confidence bound = 78%
Specificity = 74% (17/23), 95% lower confidence bound = 55%
Males:
Sensitivity = 68% (15/22), 95% lower confidence bound = 48%
Specificity = 81% (13/16), 95% lower confidence bound = 58%
