Brief Summary Statement

Product

AVVIGO II brief summary  – eIFU 51253252

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

 

INTENDED USE / INDICATIONS FOR USE

Indications for System Use

The IVUS modality of the 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.

FFR and DFR are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

Refer to the Catheter Instructions for Use provided with all Boston Scientific Ultrasound Imaging Catheters to determine compatibility with the System. All Ultrasound Imaging Catheters will be referred to as Imaging Catheters throughout the remainder of this User Guide.

The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Instructions for Use, packaged with each catheter.

 

Indications for Auto Pullback Use (IVUS Only)

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

The System has no patient alarm functions and should not be used for cardiac monitoring. Consult the Imaging Catheter, Guidewire, FFR LINK, Motordrive Unit, and the Sled Instructions for Use for a complete list of Contraindications, Adverse Events, Warnings and Precautions.

 

WARNINGS

Carefully read all instructions prior to use. Observe all indications, contraindications, warnings, and precautions noted in these directions before attempting to use the AVVIGO System.

  • The System can only be used with Boston Scientific specified accessories, imaging catheters, pressure guidewires and cables. The use of accessories and cables other than the items provided by Boston Scientific may result in increased emission or decreased immunity of the System. For questions regarding this matter, please contact Boston Scientific for technical assistance.
  • In an emergency, cut off the main electric supply to the System by switching the power OFF on the Isolation Station.
  • The System is not intended for use in the sterile field.
  • Only Use the HDMI-DVI cable provided with the system for duplicating display. Use of a different cable could result in increased electromagnetic emissions.

 

PRECAUTIONS

  • In case of abnormal System operation, the System may require shutdown and restart to bring it to normal operation. Follow the normal shutdown and startup procedures listed in the Operating Instructions.
  • If an Imaging Catheter that has not been approved for use with the System is connected, or if an Imaging Catheter is not properly connected, the corresponding Imaging Catheter identification data and Displayed Depth will not be displayed. Imaging will be disabled. Resolve this issue before continuing use.

 

ADVERSE EVENTS

Please consult the Imaging Catheter and Pressure Guidewire Instructions for Use

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