CARDIOVASCULAR
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Re-imagine PCI with Ultreon™ 1.0 Software

Streamlined and intuitive, Ultreon 1.0 Software gives better insights to optimize patient outcomes through automation and an improved workflow.1-4

  • Ultreon™ Software allows interventional cardiologists to see inside the heart during percurtenous coronary intervention (PCI) and act on the obtained insights.

  • Ultreon™ Software guides physicians through 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™ Software is powered by artificial intelligence (AI) that enables automatic quantification of calcification and vessel sizing.1

"It was worth the wait. I can see you have developed something that is really user-friendly, which was the main intent." — Pr. Souteyrand

Ultreon™ Software: The Next-Generation Imaging and Physiology Platform

See Simply & Act Decisively During PCI with Ultreon™ Software

See Simply

The Ultreon™ Software with an intuitive interface offers physicians a user-friendly on-screen information and step-by-step guidance following MLD MAX workflow to aid with decision-making;5 to determine a proper treatment technique pre-PCI and to ensure optimal stent expansion results post-PCI.
 

Ultreon™ 1.0 Software intuitive workflow interface - 1
Ultreon™ 1.0 Software intuitive workflow interface - 1
Ultreon™ 1.0 Software intuitive workflow interface - 2
Ultreon™ 1.0 Software intuitive workflow interface - 2
Morphology
Morphology screen displaying angle and max thickness of calcification
Morphology screen displaying angle and max thickness of calcification

Ultreon™ 1.0 Software uses artificial intelligence (AI) to automatically detect degree and thickness of calcification.1

  • Auto-detects and highlights calcification arc and max thickness6
  • Displays calcification angle and max thickness values throughout the pullback in real-time6
  • Highlights calcification overlays on the vessel with the co-registration view6
Sizing
Sizing screen displaying External Elastic Lamina (EEL) and Lumen diameter for proximal, current and distal frames
Sizing screen displaying External Elastic Lamina (EEL) and Lumen diameter for proximal, current and distal frames

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.1,7

  • Provides vessel diameter measurements6
  • Facilitates measuring lesion length and identification of optimal user-adjusted stent landing zones on a single screen6
  • Autodetects and provides measurement of lumen and detectable external elastic lamina (EEL) for quick visualization6
  • Facilitates stent length selection through co-registration6

Act Decisively

Deployment

Ultreon™ Software provides side-by-side viewing of live and co-registered angio to help physicians guide precise stent deployment.6

  • Helps to ensure complete lesion coverage and avoid stent edges in high-risk morphology8
Ultreon™ 1.0 Software interface for stent deployment
Ultreon™ 1.0 Software interface for stent deployment
Review

Ultreon™ Software helps to ensure optimal stent expansion and apposition with instantaneous display of expansion and apposition results.6

Ultreon™ 1.0 Software interface for review assessment
Ultreon™ 1.0 Software interface for review assessment

References

* Compared to AptiVue™ Imaging Software

  1. Data on file at Abbott.
  2. 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. doi: 10.1016/j.jacc.2018.09.013.
  3. Hong M, et al. IVUS-XPL 5 Year Outcomes, TCT 2019.
  4. Jones et al. JACC Cardiovascular Interventions, 2018, vol 11 (14). “Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention – Outcomes From the Pan-London PCI Cohort”.
  5. Bezerra H, et al. Analysis of changes in decision-making process during optical coherence tomography-guided percutaneous coronary interventions: Insights from the LightLab Intiative. EuroPCR 2020.
  6. Ultreon™ 1.0 Software IFU. Refer to Instructions For Use (IFU) for additional information.
  7. Prati, F. et al. The CLI-OPCI II Study. JACC: Cardiovascular Imaging, 2015: Vol 8, No. 11:1297-305.
  8. Kubo T, et al. Application of optical coherence tomography in percutaneous coronary intervention. Circ J. 2012;76(9):2076-2083. doi: 10.1253/circj.cj-12-0828.

MAT-2106678 v1.0

Important Safety Information

rx-only-logo  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-2106942 v1.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.