AptiVue Imaging Software

CARDIOVASCULAR

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APTIVUE™ SOFTWARE: TRUE CONFIDENCE

AptiVue™ Software, used with Abbott’s OPTIS™ Integrated System, offers state-of-the-art coronary physiology and optical
coherence tomography (OCT) imaging on one platform. This combination helps physicians quickly and clearly assess proven optimization targets. ^1-5

_{*Confidence is attributed to lower drift in the PressureWire™ X guidewire compared to previous generation. Test(s) performed by and data on file at Abbott.}

References
_{1. 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.

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.

3. Hong S-J, et al. Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. JAMA. 2015;314(20):2155-2163.

4. Prati F, et al. Clinical Impact of OCT findings during PCI: the CLI-OPCI II study. JACC Cardiovasc Img. 2015;8:1297-1305.

5. Ali ZA, et al. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016;388:2618-2628.}

OVERVIEW

EVIDENCE

ORDERING INFO

APTIVUE™ SOFTWARE: TRUE CONFIDENCE

APTIVUE™ SOFTWARE OFFERS:

Coronary physiology measurement using Resting Full-Cycle Ratio (RFR) or Fractional Flow Reserve (FFR).

RFR is Abbott’s newest novel physiological index to assess coronary stenosis severity without inducing hyperemia.
RFR allows for confident* wireless decision-making at rest or stress.
RFR is measured with the world’s only wireless pressure wire¹: PressureWire™ X Guidewire.

_{*Confidence is attributed to lower drift in the PressureWire™ X Guidewire compared to previous generation. Test(s) performed by and data on file at Abbott.}

Stent expansion – Tapered Reference Method

Colored expansion indicator automatically displays when a stent is detected
- Under-expanded region shown in red (90% default, user editable)
- Well-expanded region shown in silver

Expansion displayed on Lumen Profile and angio co-registration view

Automatic detection:
- Minimum Stent Area (MSA) frame (minimum lumen area in stented region)
- Automatic detection of minimum expansion frame (EXP)
- Both are user editable

Expansion indicator can be turned off

AptiVue™ Stent Expansion Tapered Reference Method

All post-PCI optimization information on one screen

Color-coded expansion indicator
Color-coded apposition indicator
Clear morphology images
Angio co-registration with color-coded expansion indicaton
Automatic measurements for sizing

Cybersecurity

Authentication and full encryption of personal health information (PHI), which ensures compliance with the FDA’s new standards.

References:

_{1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.}

OPTIMAL STENT EXPANSION IMPROVES OUTCOMES^1-3

During percutaneous coronary intervention (PCI), stent underexpansion is an indicator of adverse events such as stent thrombosis and restenosis.¹ Now fast and automatic stent expansion calculations are available with AptiVue™ software to ensure optimal stent expansion.

In-Stent Restenosis (ISR):

Rates of ISR are as high as 10% of the patient population today.⁵ Underexpansion is the leading cause of ISR.¹

Stent Thrombosis (ST):

While ST is rare today at ~1.5% at three years, mortality rates related to stent thrombosis may be as high as 20-40%.⁴

Adverse Cardiac Events:

Target lesion failure occurs in 1 in 6 patients at five years in current second generation DES.⁶

OUTCOMES DATA POINT TO OPTIMAL EXPANSION

Intravascular guidance of PCI has been demonstrated to reduce rates of adverse cardiac events.^2-3

ULTIMATE TRIAL²

ULTIMATE is the most recent randomized, controlled trial demonstrating that patient outcomes improve when physicians achieve greater than 90% stent expansion, as an optimization target. Patients who reached these optimization targets were classified as “optimal PCI” cases and did significantly better than those who did not reach optimized targets.

ULTIMATE trial: > 90% stent expansion was optimal PCI

Other studies noted below found similar patient safety and efficacy outcomes with optimal stent expansion.

Trial	Expansion Target or Outcome	Reduction in Adverse Cardiac Events	Year	Patients
IVUS XPL (RPT)¹	Minimal lumen area > lumen area of distal reference	MACE at 1 year: 5.8% (Angio only) vs. 2.9% (Imaging) (p = 0.007)	2015	1,400
Meta-analysis, Zhang³	Larger stent areas and diameters in imaging group	The use of imaging was associated with reductions in MACE, death and ST compared to angio only (p < 0.001)	2015	29,068
ULTIMATE (RCT)⁴	MLA in the stented segment is > 5.0 mm² or 90% of the MLA at the distal reference segments	TVF at 1 year: 5.4% (Angio only) vs. 2.9% (Imaging) (p = 0.029)	2018	1,448
ADAPT - DES 2-year follow-up (Post-hoc analysis)⁵	Longer stent lengths and larger stent sizes were used in the IVUS-guided group	MACE at 2 years: 7.5% (Angio only) vs. 4.9% (Imaging) (p = 0.029)	2018	8,582
1. Hong S et al., “Effect of Intravascular Ultrasound–Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial.” JAMA, 2015. 2. Zhang, Y., Pang, S., Chen, X., Bourantas, C. V., Pan, D., Dong, S., . . . Chen, S. (2015). Comparison of intravascular ultrasound guided versus angiography guided drug eluting stent implantation: a systematic review and meta-analysis. BMC Cardiovascular Disorders, 15, 153. 3. Zhang et al., “Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation.” ULTIMATE, JACC, 2018. 4. Dohi, Etiology, Frequency, and Clinical Outcomes of Myocardial Infarction After Successful Drug-Eluting Stent Implantation Two-Year Follow-Up From the ADAPT-DES Study Cardiac Catheterization, 2019. 5. Ali, Ziad A et al. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial The Lancet , Volume 388 , Issue 10060 , 2618 – 2628.

^{Note: Results from clinical trials are not directly comparable. Information provided for educational purposes only.}

References:

_{1. 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.

2. Hong S-J, et al. Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. JAMA. 2015;314(20):2155-2163.

3. Prati F, et al. CLinical Impact of OCT findings during PCI: the CLI-OPCI II study. JACC Cardiovasc Img. 2015;8:1297-1305.

4. Svanerud J, et al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018;14:806-814.

5. Byrne RA, et al. Stent thrombosis and restenosis: what have we learned and where are we going? Eur Heart J. 2015;36:3320-3331.

6. von Birgelen C, et al. TCT-572 final 5-year outcome after implantation of zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in the broad patient population of the randomized TWENTE trial. J Am Coll Cardiol. 2015;66(15 Suppl):B232.}

APTIVUE™ SOFTWARE UPGRADE KIT ORDERING INFORMATION

REORDER NUMBER	DESCRIPTION
1014661	AptiVue™ Software Upgrade Kit (E.5.2)
1014664	AptiVue™ Software Upgrade Kit (E.5.1) - for the ILUMIEN OPTIS Offline Review Workstation, C408651

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IMPORTANT SAFETY INFORMATION

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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.

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APTIVUE™ IMAGING SOFTWARE
FOR THE OPTIS™ SYSTEM

APTIVUE™ SOFTWARE: TRUE CONFIDENCE