Indications for Use

United States

The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter or Vis-Rx® PRIME Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter or Vis-Rx PRIME Micro-Imaging Catheter are intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter or Vis-Rx PRIME Micro-Imaging Catheter are also intended for use prior to or following transluminal interventional procedures.

The Vis-Rx Micro-Imaging Catheter or Vis-Rx PRIME Micro-Imaging Catheter are not intended for use in a target vessel that has undergone a previous bypass procedure.

For contraindications, cautions, and other information, refer to the associated user manual.

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Europe & Japan

The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter.

The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

For contraindications, cautions, and other information, refer to the associated user manual.

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