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OCT Intravascular Imaging

OPTIS™ Imaging Systems
LightLab Outcomes
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LightLab Clinical Initiative data demonstrate OCT benefits for PCI

LightLab is a multicenter, prospective, observational clinical initiative designed to evaluate the impact of using a routine OCT workflow, MLD MAX, on physician decision-making and procedural efficiency during PCI with the goal of improving cath lab workflow, safety and efficiency.

Percutaneous coronary intervention (PCI) is most commonly guided by angiography which offers a two-dimensional view of the three-dimensional structure.1 It can’t depict the arterial vessel wall, and thus evaluate vessel dimensions and plaque characteristics, nor directly assess the results of stent implantation.2 Recent LightLab data give further insights into the limitations of angiography in the cath lab and highlights the benefits of using OCT.

OCT reduced ambiguities impacting decisions on vessel prep, stent sizing, and expansion3

            OCT changed

       angio-based decisions3

  OCT changed angio-based

morphology assessment3

Pre-PCI OCT changed angio-based
diagnosis and treatment decisions 5

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OCT changed angio-based
vessel prep strategy4

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Achieved when following LL
OCT workflow, MLD MAX3

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1. OCT changed angio-based decisions in 88% of lesions3

When physicians used the full range of information from OCT with the MLD MAX workflow they changed decisions in 88% of lesions over their angiographic assessment. The largest impact was observed prior to stenting, in decisions involving morphology assessment, vessel preparation and stent sizing, key decisions which may influence final stent expansion. Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI.2

2. OCT changed angio-based assessment of morphology in nearly 1 in 2 lesions3

When physicians used OCT to assess lesion morphology and composition of the plaque, they changed their angiographic-guided assessment in about half of lesions or in 48% of lesions. Due to the high resolution images, OCT provides additional information on lesion morphology which is important to determine how to prepare and treat the vessel appropriately, especially when calcification is present. Extensive calcification may adversely impact PCI procedure and final stent expansion.2

3. OCT changed angio-based vessel prep strategy in nearly 1/3 of lesions4

Proper vessel evaluation, lesion preparation, and sizing are essential to achieve optimal stent expansion.

When physicians assessed lesion morphology and severity with OCT, they changed vessel prep strategy. When a change in vessel prep strategy occurred, calcification was the predominant morphology as seen with OCT. Angiography underestimates morphological lesion severity which impacts treatment strategy.

4. Pre-PCI OCT changed angio-based diagnosis and treatment decisions5

When physicians used OCT pre-PCI in ISR lesions, they changed their angiographic diagnosis and treatment strategy in 91% of lesions. OCT can diagnose ISR and accurately identify the mechanism of stent failure which impacts ISR treatment strategy. In LightLab, OCT changed angio assessment of ISR mechanism in 48% of lesions with a quarter of these lesions missed as ISR by angiography.

Identifying the mechanism of stent failure is paramount to planning treatment as treatment strategy differs for ISR due to stent underexpansion and due to neointimal hyperplasia.2 Analysis of ISR by intravascular imaging is essential to understand the mechanism of failure and OCT is a preferred technique.2

 

Algorithm adapted from: Ziad Ali, MD. CHIP guided by OCT, A Case Based Discussion, TCT 2017

5. Optimal stent expansion achieved with MLD MAX workflow3

Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI.2 Operators achieved 80% minimal stent expansion on average when following LightLab workflow, MLD MAX.

OCT makes it easy to detect underexpansion. Using Tapered Reference Mode, which is based on the natural tapering of vessels and factoring in side branches, OCT software automatically calculates expansion percentage % and highlights regions of underexpansion in red, well-expanded in white, see below.

Example 1: OCT software detected 67% stent expansion (A) meaning the stent is underexpanded based on the recommended expansion targets2 of MSA ≥ 80% or >90%. The software highlighted underexpansion in red, and well-expanded areas in white which can also be seen on the angio co-registration feature (B) and on the rendered stent feature (C).
Example 2: OCT software detected 86% stent expansion (A) and it is highlighted in white to indicate well-expanded stent based on the recommended expansion targets2 of MSA ≥ 80% or >90%. The software highlighted well-expanded stent in white on angio co-registration feature (B) and rendered stent feature (C).

References

  1. Reyes, M. The next innovation in PCI is not a stent. The value of OCT. CathLab Digest. Oct 6, 2019. Volume 27, Issue 10.
  2. 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.
  3. Bezerra, H. et al: Analysis of changes in decision-making process during OCT-guided PCI -Insights from the LightLab Initiative. EuroPCR2020 Presentation.
  4. Croce, K. et al: Optical Coherence Tomography Influences Procedure and Vessel Preparation Decisions During Percutaneous Coronary Intervention– Insights from the LightLab Initiative. TCTConnect2020 Presentation.
  5. Croce, K. et al: Effect of a Prescriptive Optical Coherence Tomography Guided Strategy on Treatment of In-Stent Restenosis– Insights from the LightLab Initiative. TCTConnect2020 Presentation.

MAT-2113909 v1.0

Important Safety Information

OPTIS™ Imaging Systems and Software

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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

Dragonfly™ OPTIS™ Imaging Catheter

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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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HEALTHCARE PROFESSIONALS
PATIENTS & CAREGIVERS
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MAT-1900882 v10.0