Abbott OPTIS Imaging System for OCT-Guided PCI | Abbott
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OPTIS™ Imaging Systems

OCT imaging and coronary physiology on one platform

Abbott's OPTIS™ Imaging Systems offer high resolution OCT intravascular imaging and coronary physiology (RFR*/FFR) on one platform to guide PCI with informed decisions. The OPTIS™ Imaging Systems, Integrated System and Mobile System, powered by the OCT Imaging Software which now includes coronary physiology measurement, used with the Dragonfly OpStar™ Imaging Catheter represent Abbott’s intravascular imaging products designed for imaging of coronary arteries.
 

OPTIS™ Integrated System set up. Components shown include Wi-Box™ AO Transmitter, DOC, TSC and OCT user interface displayed on Boom Monitor
OPTIS™ Integrated System set up. Components shown include Wi-Box™ AO Transmitter, DOC, TSC and OCT user interface displayed on Boom Monitor


When interventional cardiologists (ICs) have access to sophisticated OCT imaging and coronary physiology in the cath lab, data show improved outcomes during PCI stent procedures.1-3

  • LightLab Clinical Initiative data demonstrated physicians changed their angio-based decisions in 88% of lesions after using OCT to guide PCI4-5
  • Physiology-guided decision making leads to better outcomes2-3

The OPTIS™ Imaging Systems are seamlessly integrated into the cath lab and PCI workflow. Benefits include:

Access to OCT and RFR*/FFR on one system for informed PCI decision-making

  • The OPTIS™ Imaging Systems enable OCT imaging and coronary physiology measurement using resting-full cycle ratio (RFR) and fractional flow reserve (FFR). This integration provides a versatile system for the multiple modalities used during PCI, reducing set-up time and eliminating clutter from multiple cable and components.

Automated OCT software features inform aspects of PCI planning:

  • Rapid image processing: The OPTIS™ Imaging Systems have a less than a three second pullback speed enabling fast image acquisition and immediate interpretation of lesion morphology. Images appear on the OCT interface screen right after the pullback.
  • Simultaneous angio and OCT co-registration: OCT software provides real time instantaneous synchronization of angiographic and OCT images for side-by-side viewing to help physicians clearly:
      1) Identify stenotic lesion(s) and
      2) Mark stenotic locations to facilitate accurate stent placement
  • Post-PCI optimization information on one screen
    The OCT software provides post-PCI information on one screen (apposition and expansion indicators, dissection visualization) to guide a user step-by-step to optimize PCI to ensure adequate stent expansion.
Mark stenotic locations within the coronary anatomy as shown with the orange circle
Mark stenotic locations within the coronary anatomy as shown with the orange circle
The OCT software provides post-PCI information on one screen
The OCT software provides post-PCI information on one screen

Easy integration in the cath lab for workflow efficiency with fewer cables and less clutter

*RFR is available with AptiVue™ Imaging Software and Ultreon™ 1.0 Software.

 

References

OPTIS™ Imaging System IFU. Refer to Instructions For Use (IFU) for additional information.

  1. Jones DA, et al Angiography alone versus angiography plus optical coherence tomography to guide percutaneous coronary intervention. JACC: Cardiovasc Interv. 2018;11(14):1313-1321. doi: 10.1016/j.jcin.2018.01.274.
  2. Pijls, N., et al. 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. JACC Vol. 56, No. 3, 2010.
  3. Ahn JM, et al. IRIS FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT 2018.
  4. Bezerra H, et al. Analysis of changes in decision-making process during optical coherence tomography-guided percutaneous coronary interventions: new insights from the LightLab Initiative. EuroPCR 2020.
  5. Croce K. The benefits of optical coherence tomography in the cath lab. Cardiovasc News. 2020;59:15.
Important Safety Information

MAT-2106749 v1.0

IMPORTANT SAFETY INFORMATION

rx-only-logo  OPTIS™ Imaging Systems and Software

 

Indications The OPTIS™ Software and AptiVue™ E Series Software are intended to be used only with compatible OPTIS™ Imaging Systems.

The OPTIS™ Imaging System with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS™ 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: The OPTIS™ Integrated System and Mobile System with Software are 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 CABG surgery
  • Patients disqualified for PTCA
  • Severe hemodynamic instability or shock
  • Total occlusion
  • Large thrombus
  • Acute renal failure

NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.
 

Warnings:

  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Observe all advancement and movement of the Dragonfly™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
  • Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
  • If resistance is encountered during advancement or withdrawal of the Dragonfly™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
  • The Dragonfly™ Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
  • The Dragonfly™ Imaging Catheter should not be advanced through abnormally tortuous anatomy.
  • When advancing or retracting a catheter with a monorail tip through a stented vessel, the catheter may engage the stent between the junction of the Dragonfly™ Imaging Catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
  • Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
  • 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™ Imaging System if there is reason to believe the system's security has been compromised or if the system was unaccounted for 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.
  • For optimal imaging, only use 100% contrast media.
  • Store the Dragonfly™ Imaging Catheter at ambient temperature in a dry location out of direct sunlight.
  • Never attempt to attach or detach a Dragonfly™ Imaging Catheter to the DOC while the “lock” LED is lit.
  • Do not kink, sharply bend, pinch, or crush the Dragonfly™ Imaging Catheter at any time.
  • The Dragonfly™ Imaging Catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
  • The Dragonfly™ Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
  • After use, the Dragonfly™ Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • The Dragonfly™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

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