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)

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
 

Ultreon 1.0 Software Overview

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, marked by the red circle, 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.

Ultreon Morphology Screen

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
 

Ultreon 1.0 Software Coronary Calcium
How to assess coronary calcium
Ultreon 1.0 Software Modify Calcific Plaque
How to modify calcific plaque
Ultreon 1.0 Software Coronary Calcium
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: Angiography co-registration 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 the Deployment tab.

Ultreon Sizing Screen

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

Once the stent deployment is complete, a user can move to the next step by clicking the Review tab for post-PCI optimization.

Ultreon 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 displays 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 Review Screen

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

Malapposition Indicator2

Ultreon™ 1.0 Software helps ICs 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, malapposed zones are indicated by yellow bands when there’s a cluster of malapposed struts of length ≥ 1 mm and maximum circumferential angle ≥ 90 degrees
Ultreon Review Screen

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.

Ultreon Pullback 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

TCT Symposium 2021

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.

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