iLab^® Ultrasound Imaging System

Prescriptive Information

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 post-procedurally, 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.

Warnings

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.

Potential Adverse Effects

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.

Cautions

See Potential Adverse Effects above.

Trademark

iLab, iSight, iLearn, TraceAssist, Dynamic Review, Smart TGC and iReview are trademarks of Boston Scientific Corporation or its affiliates.