Indications: The Dragonfly OpStar™ Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
Contraindications: Use of the Dragonfly OpStar™ Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
Warnings:
Precautions:
Complications:
The following complications may occur as a consequence of intravascular imaging and catheterization procedure:
MAT-2115499 v3.0
Indications: The OPTIS Integrated System and Mobile System with OPTIS Software combined with Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter are intended for the imaging of coronary arteries and are indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly™ OPTIS™ Imaging Catheter are intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO, or Dragonfly™ OPTIS™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS Integrated System and Mobile System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Contraindications: The OPTIS Integrated System and Mobile System with OPTIS Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
NOTE: The system has no patient alarm functions. Do not use for cardiac monitoring.
Warnings:
Precautions:
Potential Adverse Events: Potential complications which may be encountered during all catheterization procedures include, but are not limited to: acute myocardial infarction or unstable angina, allergic reaction to the contrast media, arterial dissection, injury, or perforation, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.
MAT-2104196 v1.0
Indications: The Dragonfly™ OPTIS™ Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ OPTIS™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
Contraindications: Use of the Dragonfly™ OPTIS™ Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
Warnings and Precautions:
Potential Adverse Events: The following complications may occur as a consequence of intravascular imaging:
MAT-2115908 v2.0
MAT-2002442 v2.0