View Spec Sheet - Boston Scientific

View Spec Sheet - Boston Scientific

Boston Scientific Imaging

Commitment. Experience. Innovation.

Boston Scientific Imaging

Advancing imaging technology –

yesterday, today and tomorrow

An industry-shaping history

Over the past 15 years Boston Scientific has been a consistent

presence in the imaging market, delivering multiple generations of

imaging hardware, software and catheters. Boston Scientific has invested

more than $100 million in the advancement of imaging technology, setting

the industry gold standard for imaging excellence and bringing the first

installed system to the cath lab.

A promising future

Boston Scientific is committed to delivering imaging products you want and need

to improve patient outcomes, as evidenced by our ongoing investment in new

product development. Over the next several years Boston Scientific’s expected

product cadence includes planning for multiple software enhancements and

imaging catheters. Count on Boston Scientific for innovation-driven imaging

solutions that anticipate your needs and exceed your expectations.

Boston Scientific – the trusted source in imaging

• Delivering quality images that help you make more informed

treatment decisions

• Providing a strong, knowledgeable and stable presence in the cath lab

• Building job-specific knowledge and confidence through focused,

hands-on training initiatives

Boston Scientific Imaging

To learn more, contact your Boston Scientific representative or visit


INDICATIONS:The iLab Ultrasound Imaging System is intended for ultrasound

examinations of intravascular pathology. Intravascular ultrasound is indicated

in patients who are candidates for transluminal interventional procedures

such as angioplasty and atherectomy. Refer to the Directions for Use provided

with all Boston Scientific ultrasound imaging catheters to determine

compatibility with the iLab System.The imaging catheters generate

ultrasound images and are intended for patient examination of vascular and

cardiac anatomies. Boston Scientific manufactures a wide variety of imaging

catheters for different applications. The recommended use of each of these

catheters may vary depending on the size and type of catheter.


indicated when the following occurs:The physician/operator wants to

standardize the method in which intravascular ultrasound images are

obtained and documented: procedure-to-procedure, operator-to-operator.

• The physician/operator wants to make linear distance determinations postprocedurally,

which requires the imaging core of a catheter to be pulled back

at a known uniform speed. • Two-dimensional, longitudinal reconstruction of

the anatomy is desired.

CONTRAINDICATIONS: Use of Automatic Pullback is contraindicated where

introduction of any catheter would constitute a threat to patient safety. Use of

the imaging catheter is contraindicated where introduction of any catheter

would constitute a threat to patient safety. This instrument is contraindicated

for fetal imaging.The contraindications include the following patient

characteristics: • Bacteremia or sepsis • Coronary artery spasm • Intra-arterial

or intra-ventricle thrombosis • Life-threatening rhythmic disorders • Major

coagulation system abnormalities • Mechanical heart valves that would be

crossed by the imaging catheter • Myocardial infarction • Severe

hemodynamic instability or shock • Total occlusion • Unsuitability for balloon

angioplasty (PTCA) • Unsuitability for coronary artery bypass surgery.

COMPLICATIONS OF VASCULAR IMAGING: The risks and discomforts involved

in vascular or cardiac imaging include those associated with all

catheterization procedures. These risks or discomforts may occur at any time

with varying frequency or severity. Additionally, these complications may

necessitate additional medical treatment including surgical intervention and,

in rare instances, may result in death: Abrupt closure • Angina • Cardiac

arrhythmias including, but not limited to, ventricular tachycardia, ventricular

fibrillation and complete heart block • Catheter/guide wire/pressure wire

entrapment • Embolism • Emergent coronary artery bypass graft (CABG)

surgery • Infection • Myocardial infarction, ischemia and/or perforation • Stent

strut damage • Stroke (including cerebral vascular accident and transient

ischemic attack) • Thrombus formation • Total vessel occlusion • Valvular injury

• Vessel dissection, injury, spasm or perforation.

WARNINGS/CAUTIONS/PRECAUTIONS: Federal law restricts this device to

sale by or on the order of a physician. For further information, please consult

the iLab Ultrasound Imaging System Users Guide.

Boston Scientific Corporation

One Boston Scientific Place

Natick, MA 01760-1537

To order product or for

more information, contact

customer service at


© 2008 Boston Scientific Corporation

or its affiliates. All rights reserved.

USCV5517.121.0 10M 01/08

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