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Ultreon™ 1.0 Software

Re-Imagine PCI Using Intravascular Imaging with Optical Coherence Tomography (OCT)

Ultreon 1.0 Software has step-by-step guidance to streamline the use of OCT intravascular imaging and RFR/FFR, prioritizing ease of use for interventional cardiologists (ICs)
Imaging Workflow

Streamline PCI Workflow with Accurate Stent Placement

Ultreon™ 1.0 Software guides physicians through percutaneous coronary intervention (PCI) step-by-step following MLD MAX workflow and provides insights on morphology, vessel sizing, stent placement and post-stent optimization for more accurate decision-making.1

Pre-PCI Guidance with Ultreon™ 1.0 Software

Morphology: Automatic calcium detection2

1 in 4 patients undergoing PCI, have moderate to severe calcium.3 If left undiagnosed and untreated, it adversely impacts PCI outcomes.4 Calcified lesions limit stent expansion, which is a major predictor of stent failure, such as stent thrombosis and restenosis.5

Ultreon Software displays calcification on the morphology screen:

  • An orange arc around the cross-sectional view indicates the presence of calcium
  • Arc is displayed when calcium angle is at or above 60 degrees of circumferential calcium — Learn more about how to identify calcium with OCT
  • The white triangle in the cross-sectional view indicates maximum calcium thickness [in the current frame]
  • Total angle and max thickness values are displayed in real time throughout pullback
  • Co-registration allows the user to visualize the calcium on the angio still frame

When calcification assessment is complete, a user can click on the Sizing tab to proceed to the next step of stent sizing evaluation.

 

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Morphology screen displaying angle and max thickness of calcification

Watch how physicians use Ultreon™ 1.0 Software to assess calcific plaque and plan treatment approach

How to access lesion morphology
How to modify calcific plaque
How to review post-plaque modification

Sizing: Automatic detection of vessel diameter via EEL or Lumen2

Ultreon™ 1.0 Software uses artificial intelligence (AI) to automatically detect external elastic lamina (EEL) and lumen to help identify landing zones for accurate stent placement.1,6

  • Length: Angiographic co-regitration facilitates identification of accurate length
  • Diameter: External elastic lamina (EEL) and lumen help identify landing zones in healthy tissue for stent placement6
    • Lumen shown as a solid white or red contour line
    • EEL shown as the dotted white line in the cross-sectional image and lumen profile
Ultreon sizing screen

Ultreon™ 1.0 Software sizing screen displays sizing for vessel length and diameter

Sizing screen displays a four panel view:2

  1. Current selected frame
  2. Proximal reference frame
  3. Distal reference frame
  4. Maximized lumen profile – user can maximize the lumen profile by clicking on the icon at top left corner of lumen profile view.

Once sizing assessment is complete, a user can move to the next step by clicking Deployment tab.

Ultreon four-panel view

Ultreon™ 1.0 Software displays a four-panel view sizing screen

Deployment: Facilitation of precise stent deployment2

Ultreon™ 1.0 Software facilitates accurate stent deployment through co-registered and live angio views side-by-side.

  • Users can select a full-screen co-registered view if desired.

After stent deployment, a user can conduct an additional OCT pullback and access post-PCI optimization tools in the Review tab. Once that's complete, a user can move to the next step by clicking the Review tab for post-PCI optimization.

Ultreon stent deployment screen

Ultreon™ 1.0 Software displays stent deployment screen with angio co‑registration

Post-PCI Guidance with Ultreon™ 1.0 Software

Review: Post-stent optimization2

Ultreon™ 1.0 Software dispalys instantaneous calculations of expansion and apposition values, reference lumen diameter and lumen diameter values in color-coded markers:

  • Stent underexpansion indicator—orange
  • Stent malapposition indicator—yellow
Ultreon post-PCI review screen

Ultreon™ 1.0 Software displays post-PCI review screen with stent expansion values

Malapposition Indicator2

Ultreon™ 1.0 Software helps physicians to quickly detect stent malapposition on the cross-sectional and lumen profile views:

  • On the cross-sectional view, malapposed struts are indicated by yellow dots if the gap between the strut and the vessel wall exceeds the user’s preselected threshold setting.
  • On the Lumen profile, malapposted zones are indicated by yellow bands when there’s a cluster of malapposed strutrs of length ≥ 1 mm and maximum circumferential angle ≥ 90 degrees
Malapposition Indicator

Ultreon™ 1.0 Software displays Malapposition Indicator on the Review screen

Pullback Comparison2

Physicians can quickly compare any two pullbacks by clicking on the Menu icon in the upper right corner. See the result of your PCI through vessel visualization pre- and post-stenting on one screen.

Pullback comparison screen

Ultreon™ 1.0 Software displays pullback comparison screen

Watch how to guide PCI with Ultreon™ 1.0 Software and MLD MAX Workflow

Case-based presentation

References

  1. Data on File at Abbott.
  2. Ultreon™ 1.0 Software IFU. Refer to Instructions For Use (IFU) for additional information.
  3. Dean Kereiakes, Disrupt CAD III: Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stenting, CLD. Dec 29, 2020.
  4. Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Généreux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 06;63(17):1703-14.
  5. Shlofmitz, E., Sosa, F.A., Ali, Z.A., Waksman, R., Jeremias, A., & Shlofmitz, R. (2019). OCT-Guided Treatment of Calcified Coronary Artery Disease: Breaking the Barrier to Stent Expansion. Current Cardiovascular Imaging Reports, 12(8), 32.
  6. Prati F, et al. Clinical impact of OCT findings during PCI: the CLI-OPCI II study. JACC: Cardiovasc Imaging. 2015;8(11):1297-1305. doi: 10.1016/j.jcmg.2015.08.013.

MAT-2106766 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

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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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