Ultreon™ 1.0 Software

Indications

The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The OPTIS™ Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter 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 or Dragonfly OpStar™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ Imaging Catheter or 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. The OPTIS™ Next Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.

Contraindications: Use of the Ultreon™ 1.0 Software is contraindicated where introduction of any catheter would constitute a threat to patient safety.
Contraindications include:

• Bacteremia or sepsis
• Major coagulation system abnormalities
• Patients diagnosed with coronary artery spasm
• Patients disqualified for coronary artery bypass graft (CABG) surgery
• Patients disqualified for percutaneous transluminal coronary angioplasty (PTCA)
• Severe hemodynamic instability or shock
• Total occlusion
• Large thrombus
• Acute renal failure
• Inability to tolerate systemic anticoagulation is a contraindication to use of OCT for coronary imaging.
• PressureWire™ Guidewire is contraindicated for use in the cerebral vasculature.
• The system has no patient alarm functions. Do not use for cardiac monitoring.

Complications: The risks involved in vascular imaging include those associated with all catheterization procedures. The following complications may occur as a consequence of intravascular imaging and may necessitate additional medical treatment including surgical intervention.

• Abnormal heart rhythm or arrhythmias
• Acute myocardial infarction
• Allergic reaction to the contrast media or drug administered for the procedure
• Arterial dissection, injury, or perforation
• Bleeding
• Catheter access site reactions: sterile inflammation or granuloma
• Coronary artery spasm
• Death
• Embolism
• Myocardial ischemia
• Renal insufficiency or failure from contrast media use
• Repeat revascularization
• Thrombus formation, abrupt closure, or total occlusion
• Tissue necrosis
• Unstable angina
• Hypotension
   

Warnings:

• Refer to the contrast media Instructions for Use for general warnings and precautions relating to use of contrast media.
• The heart rate and mean pressure values shown on the OPTIS™ Next Imaging System are for reference only and are not intended to be used as the primary display.
• The system may place the point of index value at the wrong location due to pressure artifacts, for example: abnormal heartbeats, artifacts in AO (Pa) caused by flushing of guiding catheter, or valve opening / closing. The physician should always confirm that the point selected by the system is a valid point for the calculation of index value.
• Inside the catheterization laboratory, only port-powered USB drives may be connected to the USB port. Connecting externally powered devices to the USB port in the patient vicinity may compromise electrical isolation and cause patient injury.
• To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment. Do not use the OPTIS™ Next Imaging System if there is reason to believe the system’s security has been compromised or if the system was unaccounted for during a period of time (i.e., misappropriated, modified, or tampered with).
   

Precautions:

• Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
• Monitor the OCT image for indications of Dragonfly™ Imaging Catheter optical failure. If optical failure is suspected, remove the Dragonfly™ Imaging Catheter from the patient, press “Unload” on the drive motor and optical controller (DOC), detach the catheter, and replace it with a new one.
• If the pullback triggers before contrast is injected, repeat the pullback.
• For optimal imaging, only use 100% contrast media.