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
www.bostonscientific.com.
iLab ® ULTRASOUND IMAGING SYSTEM
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.
INDICATIONS FOR AUTOMATIC PULLBACK USE: Automatic Pullback is
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
www.bostonscientific.com
To order product or for
more information, contact
customer service at
1.888.272.1001.
© 2008 Boston Scientific Corporation
or its affiliates. All rights reserved.
USCV5517.121.0 10M 01/08