What is Optical Coherence Tomography (OCT) Imaging?
Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure during percutaneous coronary intervention (PCI).
"These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn’t delineate the composition of the coronary artery.1 With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.1"
— Dr. Manuel M. Reyes, Interventional Cardiologist
Ultreon™ 1.0 Software is powered by artificial intelligence (AI) and automation. It has an improved and intuitive user-interface over the previous generation.*
Ultreon™ 1.0 Software User Interface. Pre-PCI pullback. Automatically displays degree and max arc of calcification.
Ultreon™ 1.0 Software User Interface. Pre-PCI pullback. Automatically displays degree and max arc of calcification.
Ultreon™ 1.0 Software User Interface. Pre-PCI pullback. Automatically displays degree and max arc of calcification.
Ultreon™ 1.0 Software User Interface. Pre-PCI pullback. Automatically displays degree and max arc of calcification.
Previous generation AptiVue™ Software User Interface. Pre-PCI pullback.
Previous generation AptiVue™ Software User Interface. Pre-PCI pullback.
Angiogram co-registration denotes location of the cross-sectional OCT image.
Cross-sectional visualization is used to obtain detailed findings, such as structures in the lumen and in the various layers of the vessel wall.
The cross-sectional area of the vessel is visualized along the entire length of the examined vessel segment. It allows precise determination of the vessel diameter (mean reference diameter) and the length of the altered segment. The white marker is located at the position of the cross-section shown.
Viewed from left to right, the longitudinal section visualizes the scanned vessel segment from proximal to distal in Ultreon™ Software, and from distal to proximal in AptiVue™ Software.
How does OCT support PCI guidance?
For pre-PCI guidance, OCT can be used to identify the culprit lesion, assess lesion morphology to select the right lesion preparation strategy, and characterize the stent landing zones to select precise length and diameter of balloons and stents.2
For post-PCI guidance, OCT offers improved visualization of stent dissection, tissue protrusion and incomplete vessel wall apposition compared to angiography alone, thus helping to minimize stent thrombosis.3 OCT helps to confirm that stent is fully expanded to reduce stent failure.1
PCI guidance with OCT is easier now with the development of the standardized step-by-step workflow (also referred to as algorithm), MLD MAX, which is mnemonic for Morphology, Length, Diameter, Medial Dissection, Apposition and Xpansion. Using OCT with MLD MAX workflow can improve stent expansion4 without additional contrast while reducing radiation exposure compared to angiography-guided PCI.5 Stent expansion is linked to better PCI outcomes.6
AHA/ACC 2021 Guidelines
AHA/ACC 2021 Guidelines recommend intravascular imaging for PCI guidance because of limitations of angiography. OCT is recommended for stent implantation and to determine mechanism of stent underexpansion.
Ultreon™ 1.0 Software is the newest software that includes auto detection of certain components of the vessel based on artificial intelligence. The software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The first generation AptiVue™ Software is intended to be used only with compatible OPTIS™ Imaging Systems.
The hardware that runs the OCT software. OPTIS™ Systems use optical imaging catheters that emit near-infrared light to produce high-resolution real-time images. The OPTIS ™ NEXT Imaging Systems can be integrated with the cath lab angio systems to display OCT and angio co-registration (ACR) on the same screen.
To perform an OCT pullback, an OCT catheter is inserted into the vessel and an infrared laser is used to scan the vessel wall in a spiral-like manner. The laser beam penetrates the tissue 2-3mm deep, is reflected from there and returned to the OCT device via the catheter for evaluation.7
How to set up the system for OCT-guided PCI
Watch this video to learn how to set up the OCT system. These step-by-step instructions are available on the OCT screen for easy guidance.
Watch this video to learn how to initiate a pullback. The step-by-step instructions are also available on the OCT screen.
Due to the OCT systems’ high acquisition speed, images of pullback can be produced and visualized in a matter of seconds. The system provides precise information about the scanned vessel segment.7
How to interpret OCT images with Dr. Ziad Ali, Interventional Cardiologist
OCT and MLD MAX Workflow
Using OCT with MLD MAX workflow, the standardized step-by-step workflow, helps to guide pre- and post-PCI decisions. Use of the workflow resulted in an 88% change in treatment decisions8 compared to angiography alone without a change in contrast usage and a 10% reduction in radiation5, as shown in the LightLab Clinical Initiative.
Six letters represent six steps of the PCI goal to MAX-imize stent expansion to deliver optimal results.
The first three steps, MLD (Morphology, Length, Diameter) performed before PCI, designed to help inform treatment strategy.
The last three steps, MAX (Medial Dissection, Apposition, Xpansion), performed post-PCI, to optimize stent placement. MLD MAX was developed as a part of the LightLab Clinical Initiative.
Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI9. Proper expansion confirmed by imaging results in safety and efficacy benefits.6
Select Landing Zones Based on Healthy Tissue/ EEL Visualization2
Diameter
Measure Vessel, Stent, Balloon Diameters4
Criteria: >180 degrees, and >0.5 mm thickness, and >5 mm in length
Place landing zones in healthy tissue (i.e. EEL visualization)
Note: In the absence of EEL to represent healthy tissue find the largest lumen to avoid areas of TCFA or lipid pools so as to not land your stent edge in these high-risk areas3
Use distal reference measurements to select stent diameter
Use distal reference measurement for distal balloons or proximal reference measurements for proximal balloons
Medial Dissection
Address Significant Dissection2
Apposition
Address Gross Malapposition
Xpansion
Confirm Expansion3,6
Criteria:
Dissection penetrates medial layer, and is greater than 1 quadrant arc
Criteria: Malapposition indicator shows longer than 3 mm4 of significant (≥0.3 mm from wall5) apposition
Criteria:
≥80% acceptable, ≥90% expansion is optimal
“When we use the OCT workflow (MLD MAX), we make better decisions initially by analyzing the plaque morphology and determining appropriate vessel prep as well as selecting the appropriate stent length and diameter. By doing this, we are less likely to have to do post-PCI optimization because we are doing it right the first time. This often leads to improved procedural efficiency.”
— Dr. Jason Wollmuth, Interventional Cardiologist
How to apply MLD MAX workflow to OCT‑guided PCI?
Watch these videos to learn more about each step of the MLD MAX workflow: Morphology, Length, Diameter, Medial dissection, Apposition, and Xpansion. If you are already using Ultreon™ 1.0 Software, see how to apply MLD MAX and Ultreon™ Software to an OCT-guided PCI.
Pre-PCI Guidance: MLD | Morphology, Length, Diameter are used to determine PCI strategy.
Morphology
What is the value of morphology-guided lesion prep?
Understanding vessel morphology and plaque characteristics (lipidic, fibrotic or calcific) allows user to determine vessel preparation strategy (i.e. if direct stenting is okay or if plaque modification is required).
In this video, Dr. Ziad Ali provides a detailed overview of the structure of the normal vessel morphology, how it displays on OCT and shares an easy-to-use OCT image interpretation algorithm.
Dr. Ziad Ali discusses vessel preparation strategies based on plaque type, and the influence on coronary calcium on stent expansion. Learn more about OCT in calcified lesions.
Incomplete lesion coverage is a predictor of stent failure (stent thrombosis and restenosis) and MACE.9 The stent should completely cover the lesion and avoid stent edges in high-risk morphology.10
In this video, Dr. Ziad Ali shows how to measure lesion length for an OCT-guided PCI.
Appropriate sizing of stent diameter is important to limit underexpansion, malapposition and dissections.
Angiography both over- and underestimates stent diameter to a similar degree and led to an inaccurate stent diameter in 38% of stented lesions as demonstrated in the LightLab Clinical Initiative.8
In this video, Dr Ziad Ali shows how to measure diameter with an easy-to-use sizing algorithm.
Post-PCI Guidance: MAX | Medial dissection, Apposition, Xpansion are used to optimize stent placement to ensure optimal expansion.
Medial Dissection
There are three types of dissections: intimal, medial and intramural hematoma. A dissection which penetrates the medial layer and > 1 quadrant arc needs to be treated although various recommended angles exist, including > 60 degrees.9 A simplified approach used by operators is to measure a 1 quadrant arc.
MLD MAX was developed to address medial dissections. Medial dissections are an independent predictor of MACE if they are at the distal edge of the stent and ≥ 200 µm.10
In this video, Dr. Ziad Ali shows how to review for medial dissections with OCT.
How to review for medial dissections using MLD MAX
Apposition
What is stent apposition?
If the stent struts are in contact with the vessel wall, the stent is apposed. Extensively malapposed stent struts have been shown to lead to stent thrombosis.9
In this video, Dr. Ziad Ali shows how to easily check for stent malapposition with OCT.
An important aspect of optimizing PCI is the detection of underexpansion after stent placement.9
Underexpansion is a predictor of adverse events, (i.e. stent thrombosis and restenosis). Achieving optimal expansion is proven to reduce rates of adverse events.9
In this video, Dr. Ziad Ali shows how to confirm stent expansion using OCT.
Reyes, M. The next innovation in PCI is not a stent. The value of OCT. CathLab Digest. Oct 6, 2019. Volume 27, Issue 10.
Ali, Z. et al. Intracoronary optical coherence tomography: state of the art and future directions. EuroIntervention 2021;17:e105-e123. DOI: 10.4244/EIJ-D-21-00089
AptiVue Software IFU. Refer to Instructions For Use (IFU) for additional information.
Khuddus, M. et al. Cardiac Catheterization Laboratory Efficiency and Quality Improvement during Percutaneous Coronary Intervention (PCI) Utilizing a Standardized Optimal Coherence Tomography (OCT) Workflow in a Real-World Setting: Results from the LightLab Initiative. CRT 2021.
Rauch, J. et al. Standardized Optical Coherence Tomography Workflow Improves Procedural Efficiency and Safety During Percutaneous Coronary Intervention: Insights from the LightLab Clinical Initiative. TCT2021.
Zhang, J. et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol. 2018;72(24):3126-3137.
Nef, Holger. OCT Compendium. Chapter 1. Systemic OCT image evaluation. First edition, 2016, Germany.
Bezerra, H. et al: Analysis of changes in decision-making process during OCT-guided PCI -Insights from the LightLab Initiative. EuroPCR2020 Presentation.
Räber, L. et al. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018;39(35):3281-3300.
Prati, F. et al. The CLI-OPCI II Study. JACC: Cardiovascular Imaging, 2015: Vol 8, No. 11:1297-305.
References - MLD MAX graphic
Fujino, A. et al. A new optical coherence tomography-based calcium scoring system to predict stent under expansion. EuroIntervention, April 2018; 13(18):e2182-e2189.
Prati, F. et al. The CLI-OPCI II Study. JACC: Cardiovascular Imaging, 2015: Vol 8, No. 11:1297-305.
Kubo, T. et al. Application of Optical Coherence Tomography in Percutaneous Coronary Intervention. Circulation Journal, September 2012: Vol. 76, 2076-2083.
Ali, Z. et al. ILUMIEN III: Optimize PCI. Lancet 2016, 388:2618-2628.
Souteyrand, G. et al. PESTO French Registry. European Heart Journal, 2016:37:1208-1216.
Meneveau, N. et al. DOCTORS Study. Circulation, September 2016, 134:906-917.; Zhang, J. et al. The ULTIMATE Trial. Journal of the American College of Cardiology, Dec 2018: Vol 72, No 24:3126-37.; Russo, R. et al. The AVID Trial. Circ Cardiovasc Intervent, April 2009; 2:113-123.; De Jaegere, P. et al. MUSIC Study. European Heart Journal, February 1998:19,1214-1223.
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MAT-2113908 v2.0
IMPORTANT SAFETY INFORMATION
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.
MAT-2115909 v2.0
OPTIS™ Next Imaging Systems and 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.
MAT-2104193 v3.0
Dragonfly OpStar™ Imaging Catheter
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:
Acute renal failure
Bacteremia or sepsis
Large thrombus
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
Inability to tolerate systemic anticoagulation is a contraindication to use of OCT for coronary imaging
Warnings And Precautions:
Appropriate anticoagulant and vasodilator therapy is recommended to be used during the procedure as ordered by the physician.
The Dragonfly OpStar™ 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. Do not reuse or re-sterilize. Any attempt to reuse or re-sterilize may compromise the structural integrity of this device. Adverse effects of using a non-sterile or re-sterilized imaging catheter may include, but are not limited to:
Local and/or systemic infection
Mechanical damage
Inaccurate results
Note the product "Use by" date on the package.
Observe all advancement and movement of the Dragonfly OpStar™ 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. To ensure proper placement, do not move the guide wire after the Dragonfly OpStar™ Imaging Catheter is in place.
If resistance is encountered during advancement or withdrawal of the Dragonfly OpStar™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the Dragonfly OpStar™ Imaging Catheter and guide wire as a unit from the patient.
Leave the guide wire engaged with the Dragonfly OpStar™ Imaging Catheter at all times during use. Do not retract or advance the guide wire prior to withdrawing the Dragonfly OpStar™ Imaging Catheter.
The Dragonfly OpStar™ 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 OpStar™ Imaging Catheter should not be advanced through abnormally tortuous anatomy.
When advancing or retracting a Dragonfly OpStar™ Imaging Catheter with a monorail tip through a stented vessel, the Dragonfly imaging catheter may engage the stent between the junction of the Dragonfly OpStar™ Imaging Catheter and guide wire, resulting in entrapment of the catheter/guide wire, catheter tip separation, stent dislocation and/or vascular injury.
Do not remove the Dragonfly OpStar™ Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.
Always verify that the Dragonfly OpStar™ Imaging Catheter has been properly prepared prior to inserting into vasculature.
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 mm to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
Use the minimum flush rate and volume required to image the desired anatomy.
For optimal imaging, only use 100% contrast media.
Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.
Do not kink, sharply bend, pinch, or crush the Dragonfly OpStar™ Imaging Catheter at any time.
The Dragonfly OpStar™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the Dragonfly OpStar™ Imaging Catheter assembly as provided.
After use, the Dragonfly OpStar™ Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
The instructions for use are recyclable. Dispose of all packaging materials appropriately.
When using saline, heparinized saline is recommended.
The Dragonfly OpStar™ Imaging Catheter must be purged prior to connection to the DOC to prevent damage to the imaging core.
Ensure that the Dragonfly OpStar™ Imaging Catheter tip marker has been properly identified and differentiated from the lens marker before contrast administration and prior to performing the OCT reading.
Never attempt to attach or detach the Dragonfly OpStar™ Imaging Catheter to the DOC while the "lock" LED is lit.
Potential Adverse Events: The following complications may occur as a consequence of intravascular imaging and catheterization procedure:
Allergic reaction to the contrast media or drug administered for the procedure
Bleeding
Arterial dissection, injury or perforation
Abnormal heart rhythm or arrhythmias
Unstable angina
Coronary artery spasm
Thrombus formation, abrupt closure, or total occlusion
Embolism
Myocardial ischemia
Acute myocardial infarction
Repeat revascularization
Renal insufficiency or failure from contrast media use
Death
Catheter access side reactions: sterile inflammation or granuloma or tissue necrosis
MAT-2115499 v2.0
Dragonfly™ OPTIS™ Imaging Catheter
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:
Bacteremia or sepsis
Major coagulation system abnormalities
Patients disqualified for CABG surgery
Patients disqualified for PTCA
Severe hemodynamic instability or shock
Patients diagnosed with coronary artery spasm
Total occlusion
Large thrombus
Acute renal failure
Warnings and Precautions:
Store at ambient temperature in a dry location out of direct sunlight.
Ensure the catheter is at room temperature (10°C to 32°C) before use.
This device 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. Do not reuse or re-sterilize.
Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
Observe all advancement and movement of the Dragonfly™ OPTIS™ 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. To assure proper placement do not move the guide wire after the Dragonfly™ OPTIS™ Imaging Catheter is in place.
If resistance is encountered during advancement or withdrawal of the Dragonfly™ OPTIS™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.
Use the minimum flush rate and volume required to image the desired anatomy.
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
The instructions for use are recyclable. Dispose of all packaging materials appropriately.
Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.
This package contains a Sterile Single Use Only Device. Any attempt to re-use or re-sterilize may compromise the structural integrity of this device.
Do not remove the Dragonfly™ OPTIS™ Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.
Always verify that the catheter has been properly prepared prior to inserting into vasculature.
Potential Adverse Events: The following complications may occur as a consequence of intravascular imaging:
Coronary artery spasm
Unstable angina
Allergic reaction to the contrast media
Arterial dissection, injury or perforation
Thrombus formation, abrupt closure, or total occlusion
Abnormal heart arrhythmias
Embolism
Acute myocardial infarction
Death
MAT-2115908 v2.0
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The information provided here is not intended to provide information to patients and the general public.
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
OPTIS™ Imaging Systems and Software
