Over the last 20 years, we’ve helped improve the lives of 35 million
patients and counting in over 75 countries around the worldSince then, ACIST has become a knowledge catalyst, helping interventional cardiologists quickly visualize,
assess and improve patient treatment globally with over 400+ employees worldwide.
Acquired in 2001 and backed by the power of Bracco, a world-class leader in diagnostic imaging, ourexpanding product and service offering delivers the flexibility clinicians want to get the insights they need.

ACIST CVi

ACIST HDi

Prior to use, reference Instructions for Use, inside the product carton (when available) or at www.acist.com for moredetailed information on safe use of the device.

Prior to use, reference Instructions for Use, inside the product carton (when available) or at https://acist.com/library/ formore detailed information on safe use of the device.

Indications for Use: The ACIST CVi Contrast Delivery System is intended to be used for the controlled infusion ofradiopaque contrast media for angiographic procedures.

Indications for Use: The ACIST HDi® System is intended to be used for the ultrasound examination of coronary andperipheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates fortransluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with theACIST HDi System.

®

Contraindications: The ACIST CVi® Contrast Delivery System (CVi system) is not intended for use as a long-term infusion
pump. The system is not intended to be used to inject any agents other than contrast media. The system should not beused to inject substances into nonvascular body cavities. Any applications of the system, other than those describedin this manual, are inappropriate and should not be attempted. Do not add any components to the consumable kits
or in conjunction with the catheter. No valves or other manifolds may be placed in-line between the ACIST-provided
consumable kit and the catheter. ACIST-provided consumable kits are designed, manufactured, and tested for connection
to catheters used in angiographic procedures. Do not use the system in the presence of flammable gases.
Important Safety Info: The CVi System is designed to aid the physician in the injection of contrast media duringangiography. It should be used with adequate radiographic imaging and where monitoring equipment for blood pressure
and the electrocardiogram is available. Additionally, standard equipment for cardiopulmonary resuscitation and drugs
for the treatment of contrast media-induced drug reactions should be present. It is necessary that the CVi system beoperated by, or be under the immediate and direct supervision of a physician who is specifically trained in angiography
and in the operation of this unit. System operation must be monitored at all times, and specific operational andmechanical integrity must be maintained to ensure patient safety.
For proper operation and to ensure equipment compatibility, use only accessories and options provided or specified
by ACIST Medical Systems for use with the CVi system. To ensure proper operation of the syringe, viscosity limits
must be observed. Do not allow the reusable syringe kit to sit loaded with contrast media longer than the maximum
time recommended by the contrast manufacturer. Do not allow the reusable syringe kit to be used for more than five(5) procedures. Replace the automated manifold and hand controller kits after each procedure. Use of the syringe
kit for more than five (5) procedures or re-use of the automated manifold and hand controller kits may result in crosscontamination, risk of infection or device malfunction, for example, air ingress, leaks, or reduced performance. An airembolism can cause patient injury or death. Operator vigilance and care, along with a defined procedure, are essential
to avoid injecting air and causing an air embolism. Before injections, clear all air from the entire patient kit and theangiographic catheter. Make sure that the exterior of the tubing is dry before inserting it into the air column detect sensor.
If any fluid is present on the tubing’s exterior surface, the sensor may be unable to detect air. High flow rate injections cancause patient injury or death. Use extreme care when setting the flow rate to avoid unintentionally setting a high flow rate
injection. When high flow rate injection is required, be sure to select a pressure setting that does not exceed the ratedpressure of the selected catheter.

ACIST informs interventional
decisions during peripheral,
cardiovascular disease andstructural heart procedures.
Physicians worldwide rely on our diagnostic
technologies to give them the power to visualize,
assess and inform patient treatment. Economic
decision-makers appreciate our ability to demonstrate
the value of therapeutic intervention.

How much contrast
have I delivered?

Is an intervention
needed?

Have I optimized
my intervention?

ACIST. It’s how you know.

Contraindications: Contraindicated for patients with: bacteremia or sepsis; arterial spasm; major coagulation systemabnormalities; mechanical heart valves that would be crossed by the catheter; severe hemodynamic instability or shock;total vessel occlusion (prior to initial stages of revascularization). Contraindicated for use in the cerebrovascular arteries.
In coronary procedures, the product is also contraindicated for patients who are: disqualified for revascularization surgery;disqualified for balloon angioplasty (PTCA).
Important Safety Info: Intravascular ultrasound studies using this product should be performed only by physicians andother medical professionals fully trained in the required techniques and procedures. The Kodama catheter contains a
short monorail guidewire engagement system. As such, it is susceptible to guidewire entanglement and/or prolapse
during catheter deployment and withdrawal. Before use and when possible during use, inspect the Kodama catheter
carefully for kinks or any other damage. Do not use a kinked or damaged catheter because vessel damage and/or theinability to advance or withdraw the catheter may occur.
Never advance or withdraw the Kodama catheter against resistance until the cause of the resistance is determined byfluoroscopy. Movement of the catheter or guidewire against resistance may result in elongation or separation of thecatheter or guidewire tip, damage to the catheter, or vessel perforation.
When advancing the Kodama catheter through a stented vessel, short monorail catheter designs are susceptible toguidewire/ catheter entrapment, catheter tip separation, and/or stent dislocation.
Adverse events that may occur as a consequence of intravascular ultrasound imaging include (but are not limited to):vessel occlusion and/or abrupt closure; air embolism; vessel dissection, injury, or perforation; vessel rupture, injury,or perforation; acute myocardial infarction; cardiac arrhythmias including but not limited to ventricular tachycardia,ventricular fibrillation, and complete heart block; cardiac tamponade; catheter/guidewire entrapment; catheter
induced ischemia; death; vessel trauma requiring treatment/surgical intervention, including angioplasty/stent;
infection; stent strut damage; stroke (including cerebral vascular accident and transient ischemic attack); thrombus
formation or thromboembolism; vasospasm.

ACIST RXiYour Cath Lab
Knowledge
Catalysts

Prior to use, reference Instructions for Use, inside the product carton (when available) or at acist.com for more detailed
information on safe use of the device.
Indications for Use: The ACIST RXi System is indicated for obtaining intravascular pressure measurements for use inthe diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus & Navvus II MicroCatheter isintended for use with the entire family of ACIST RXi Systems.
Contraindications: The ACIST Navvus Catheters are contraindicated for use in the cerebral vasculature.
Important Safety Info: The RXi System is to be used only on order of a physician by medical professionals with adequate
training and experience in the operation of the RXi System and angiographic procedures and techniques. Additionally,individuals using this device must be alert and attentive to the operation of the system while it is connected to thepatient catheter. Diligence on the part of the user is an essential requirement of overall device safety. The RXi system is
not intended for use as a blood pressure monitoring system. Prior to use and whenever possible during the procedure,carefully inspect the Navvus Catheter for kinks or any other damage. Do not use a kinked or damaged catheter because
vessel damage and/or inability to advance or withdraw the catheter may occur. When delivering the Navvus Catheter overthe guidewire, ensure that the guidewire and the Navvus Catheter are freely moving within the vessel wall. Failure to do somay traumatize the vessel. The Navvus Catheter is not designed to be torqued. Do not excessively torque the catheter.
Never advance or withdraw the Navvus Catheter against resistance until the cause of the resistance is determinedby fluoroscopy. Movement of the catheter or guidewire against resistance may result in separation of the catheter orguidewire tip, damage to the catheter, or vessel perforation. This product should not be used in rooms containing
magnetic resonance imaging (MRI) equipment. To avoid inaccurate arterial pressure measurements, the use of guidecatheters larger than 8F or guide catheters with side holes are not recommended. The Navvus Catheter is not compatible
with 4F guide catheters. Do not perform high pressure (> 600 psi) fluid injections while the Navvus Catheter tip is inside aguide catheter. Potential complications that may be encountered during all catheterization procedures include, but are notlimited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, intimal disruption,
distal embolization of blood clots and plaque, myocardial infarction, serious arrhythmias, or death.

It’s how you know.

1. Minsinger KD, Kassis HM, Block CA, Sidhu M, Brown JR (2014) Meta-analysis of the effect of automated contrast injection devices versus manual injection and contrast volume on risk of contrast-induced nephropathy. Am J Cardiol 113 (1): 49-53.
2. Call J, Sacrinty M, Applegate R, Little W, Santos R et al. (2006) Automated contrast injection in contemporary practice during cardiac catheterization and PCI: effects on contrast-induced nephropathy. J Invasive Cardiol 18 (10): 469-474.
3. Klein LW, Tra Y, Garratt KN, et al. Occupational health hazards of interventional cardiologists in the current decade: results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv. 2015;86(5):913-924. 5.
4. Amin et al. Incremental Cost of Acute Kidney Injury after Percutaneous Coronary Intervention in the United States. Am J Cardiol 2020;125:29−33 6.
5. Wilson, Robert F., John P. Gainor, and Blair Allen. “The Effect of Stepping Back From the X-Ray Table on Operator Radiation Exposure.” Health Physics 121.5 (2021): 522-530.
6. Lehmann C, Hotaling M (2005) Saving time, saving money: a time and motion study with contrast management systems. J Invasive Cardiol 17 (2):118-121; quiz 122.
7. TR-08707: Compared with Navvus. FFR MicroCatheter in benchtop testing. Data on file at ACIST. May not be indicative of clinical performance.
8. TR-07888: Compared with Navvus. FFR MicroCatheter internal testing. Data on file at ACIST. May not be indicative of clinical performance.
9. TR-07888: Compared with Navvus. FFR MicroCatheter in benchtop testing. Data on file at ACIST. May not be indicative of clinical performance.
10.	William F. Fearon , Jeffrey W. Chambers, Arnold H. Seto, Ian J. Sarembock, Ganesh Raveendran, Charlotte Sakarovitch, Lingyao Yang, Manisha Desai, Allen Jeremias, and Matthew J. Price and for the ACIST-FFR Study Investigators.
Originally published 15 Dec 2017 https://doi.org/10.1161/CIRCINTERVENTIONS.117.005905Circulation: Cardiovascular Interventions. 2017;10:e005905.
11. Data on file -TR-4050 – Study Summary for Kodama Catheter performance.
12. https://www.bostonscientific.com/content/gwc/en-US/products/ffr-ivus-systems/polaris.html Boston Scientific max pull back speed 1 mm/sec. Time reduction in during automated pullback comparing the maximum speed
13. IVUS-Guided Versus OCT-Guided Coronary Stent Implantation: A Critical Appraisal https://doi.org/10.1016/j.jcmg.2017.09.008
14.	Ahn et al. Am J Cardiol 2014;113:1338e1347. Meta-Analysis of Outcomes After Intravascular Ultrasound Guided Versus Angiography-Guided Drug-Eluting Stent Implantation in 26,503 Patients Enrolled in Three Randomized Trials and 14
Observational Studies.
15. Alberti, A., Giudice, P., Gelera, A. et al. Understanding the economic impact of intravascular ultrasound (IVUS). Eur J Health Econ 17, 185–193 (2016). https://doi.org/10.1007/s10198-015-0670-4.
16.	Tanaka S, Sakamoto K, Kitahara H, et al. Assessments of lipid plaque and thrombus with a novel high-definition 60-MHz IVUS imaging system: comparison with conventional 40-MHz IVUS and optical coherence tomography. J Am Coll Cardiol.
2013;62(18_S1):B201-B202. http://www.onlinejacc.org/content/61/10_Supplement/E1878.

ACIST, ACIST CVi, ACIST HDi, ACIST RXi, Kodama, Navvus and AngioTouch are trademarks of ACIST Medical Systems, Inc. ACIST Medical Systems, Inc. reserves
the right to modify the specifications and features described herein or discontinue manufacture of the products described at any time without prior notice or obligation.
Please contact your authorized ACIST representative for the most current information.
© 2021 ACIST Medical Systems, Inc. All Rights Reserved. PN: 30-100221_EU 11/21 Rev 1

Bracco GroupClinical and Economic ValueFrom helping to reduce and track contrast delivery,1
to enabling physicians to use their 0.014" guidewireof choice, to optimized imaging.2
ACIST gives you the power to makethose critical decisions.

Increase safety andoperational efficiency

ACIST is YOUR diagnostic
partner providing you
clinical and economic
value every day.

ACIST CVi delivers the power to reducedelivered contrast, minimizing the risk ofcontrast-induced acute kidney injury (CI-AKI).*

Beyond their clinical effectiveness, our diagnostics
also validate the appropriateness of therapeuticintervention to improve patient outcomes.

ACIST AT X65 provides a more defined
hemodynamic signal, without usinga hand manifold.
*When compared to manual injection of contrast media: 22%
reduction in contrast use without compromising image quality.1

with dPR(Diastolic Pressure Ratio), the Non-Hyperemic
Index for Coronary Physiology

Efficiently assess, and confirm
coronary artery disease, evenin the most complex cases
RXi and the ultra-thin Navvus® II MicroCatheter
provides you with the power to simplify assessmentof complex coronary artery disease using your0.014”guidewire of choice.
dPR provides a non-hyperemic alternative forphysiological assessment of coronary disease. Nonhyperemic pressure ratios, such as dPR, may reduce
patient discomfort,* cost** and procedural time.****	Reduced side effect profile when comparing resting approach (iFR, dPR, Pd/Pa) to FFR
with adenosine induced hyperemia.
**	Cost savings based on the reduced cost of utilizing a resting approach compared
to conventional FFR and respective cost of administration of hyperemic agent (adenosine).
*** When comparing resting index (iFR, dPR, Pd/Pa) to FFR with adenosine induced hyperemia.

The system of choicefor optimized imaging in
percutaneous coronary andperipheral interventions
ACIST HDi with advanced imaging modes
provides a better defined IVUS image
for pre-procedural planning and postprocedural assessment.2
LumenView™
For a better defined
lumen bordervisualization*

SilkView™
For a softer gray scale
and more definedplaque visualization** Data on file - TR-07057 – Internal Testing.

ClassicView™
Utilizes bloodspeckle to define theintravascular space*CVi•U p to 30% reduction in CI-AKI vs. manual injection1,2• 49.4% of Interventional Cardiologists have experienced at least one
orthopedic injury.3 CVi may reduce repetitive stress injuries that canbe caused by manual contrast injection.
• Up to 50% reduction in clinician radiation exposure by stepping back.5• Average 5 min faster per procedure, which may allow for additional
procedures to be performed in a day 6
CVi Consumable Kits
ATX and ATP Hand Controller Kits
Multi-use Syringe
Automated Manifold
Pressure Monitoring Set

ACIST Navvus II Rapid Exchange
FFR MicroCatheter• 13% reduced lesion entry profile7,8 to streamline
contouring in allowing navigation of complex diseases.
• 28% improved flexibility9• Maximize control by enabling you to use the 0.014" guidewireof choice to maintain wire position• Consistent and reliable10 fiber optic technology may be lesssusceptible to clinically significant drift compared to traditionalpressure wire.*
RXi System•R equires zeroing only once, at initial install,when in stationary mode•R eady when you are, displaying patient’s aortic pressure*Difference did not reach statistical significance in clinical trial.

HDi High-Definition IVUS Systemwith Extended Field of View
Kodama IVUS Catheter• Improved deliverability11 and optimized imaging2 with the offset distal tip• High-speed pullback – 10x faster pullback; 90%-time reduction12• Better visualization of media with 60 MHz IVUS than OCT for
optimizing stent sizing13• Interactive compact HDi console with touch screen for
rapid analysis and small footprint• 0.014" guidewire compatible; 20 mm max imaging diameter
IVUS Benefits• IVUS use changed the treatment strategy during the procedure
74% of the time13• IVUS-guided PCI was significantly associated with lower risk ofdeath, myocardial infarction, revascularization, and stent thrombosis14• IVUS is less expensive and more effective than angiography in
71% of PCI procedures15