The only FDA-indicated technology for contrast volume reduction.

Proven Contrast Reduction with Uncompromised Image Quality

Clinical guidelines to reduce contrast- induced AKIEvidence-based guidelines for coronary angiography in patients at risk for contrast-induced AKI.

• Limit contrast dose as low as clinically possible.

• Monitor total contrast administered to the patient in real time.

• Establish contrast dose threshold volumes to help limit risk.

Minimize dye.The call to minimize and monitor contrast dye in patients with CKD and other at-risk factors is well established in the clinical literature.2

3. MINIMIZE DYE. In patients with CKD (eGFR <60mL/min), the volume of contrast media should be minimized.

2. HYDRATE. Patients undergoing cardiac catheterization with contrast media should receive adequate preparatory hydration.

1. SCREEN. Patients should be assessed for risk of contrast-induced AKI before PCI.

“Thus far, the only strategies clearly shown to reduce the risk of contrast-induced AKI are hydration and minimizing the amount of contrast media.”1

– Levine, et al. ACC/AHA/SCAI guidelines JACC 2011

Contrast ReductionReal-time MonitoringUncompromised Imaging

• Simple one-step prep

• Module, syringe and monitor connect via Bluetooth

The DyeVert™ PLUS EZ Contrast Reduction System is a dye management

delivery solution for patients with at-risk kidney factors, including chronic

kidney disease, diabetes, older age, and heart failure. It reduces contrast

volume to the patient and provides real-time dose monitoring throughout

the procedure. Quick, easy set-up, and uncompromised image quality makes

DyeVert PLUS EZ the smart way to help mitigate the risk of AKI in the cath lab.

• Simple one-step prep

• Module, syringe and monitor connect via Bluetooth

Uncompromised ImagingInjections into coronary arteries may result in excess reflux into the aorta that is not needed for imaging.

DyeVert reduces contrast amount without compromising image quality, as seen by minimization of excess reflux.

With Contrast Reduction Without Contrast Reduction

Reduced contrast refl ux leads to decreased volume usage

Contrast refl ux leads to increased unnecessary volume usage

Over 40% Average Contrast ReductionA randomized controlled trial showed significant contrast reduction with uncompromising imaging in comparison to the control group.3 This result was further supported in a US multi-center study that confirmed over 40% average contrast reduction.4

% C

ontr

ast I

njec

ted

to P

atie

nt

OVER 40% AVERAGE REDUCTION IN CONTRAST DOSAGE TO THE PATIENT

Control Group

DyeVert Randomized Controlled Trial (N=94)

DyeVert Group

1020

30

40

50

60

70

80

90

100

0

41% VolumeReduction

Desch, S. et al., “Impact of a novel contrast reduction system on contrast savings in coronary angiography –

The DyeVert randomised controlled trial,” Int J Cardiol (2018), https://doi.org/10.1016/j.ijcard.2017.12.107

Reduced Contrast Decreases AKI RiskPatients with pre-existing chronic kidney disease are at high risk of contrast-induced acute kidney injury (AKI), also known as contrast-induced nephropathy (CIN).

* Adapted from Gurm et al.Journal of Invasive Cardiology. April 2016, Vol 28, no 4; page 142-146

Exp

ecte

d r

edu

ctio

n in

AK

I (%

)

Reduction in Contrast Volume (%)

5%

10%

15%

20%

25%

010 20 30 40 50

13-18% Reduction in AKI

30-45%Contrast Reduction

= Contrast sparing intervention used in all patients

0

MODEL PREDICTED REDUCTION IN TOTAL AKI CASES BY PERCENT REDUCTION IN CONTRAST VOLUME*

Establish Contrast Threshold Volume Monitor contrast volume to a prespecified threshold based on patient kidney function.

Clinical study publications reinforce the value of setting thresholds to reduce AKI.

Accurate Volume Recording Supports PCI performance measures issued by the cardiology professional societies to improve quality of care.

A Total contrast volume delivered

B Percent to threshold achieved

C Contrast volume saved

D Contrast percent saved

Real-Time Dose Monitoring Automatically keep track of the amount of contrast delivered to patient during procedure.

A Cumulative contrast volume

B Volume per injection

C Triple toggle button • Percent saved on last injection • Average percent saved over case• Percent of contrast in syringe

D Amount remaining until threshold reached

E Contrast threshold volume

First Author,Year (Ref. #)

Study Populationand Procedure

Contrast Volume Threshold Algorithm Based on Kidney Function

Gurm et al., 20116 58,957 PCI < 2.0 contrast vol/eGFR ratio

Laskey et al., 20077 3,179 PCI < 3.7 contrast vol/eGFR ratio

Brown et al., 20108 10,065 PCI < 5 ml x body wgt/SCr

eGFR = estimated Glomerular Filtration Rate; PCI = Percutaneous Coronary Intervention;SCr = Serum Creatinine; vol = volume; wgt = weight.

B D

AC

D

E

B

C

A

Published Contrast Threshold Volumes5

EC REP

• Simple, one-step prep

• Interfaces with standard manifold systems

• Easy-to-use and incorporate into workflow

• Diverts contrast on each injection, including puffs

• Proprietary Pressure Compensating Valve system automatically self adjusts for different catheter configurations, contrast types and injection rates

Disposable, STERILE (Single-Use) components

Model No. Description Used With UOM Qty

HV-EZ-RRS-10 DyeVert PLUS EZ Disposable Kit Contents: Module with Smart-Syringe (Ring Plunger-Ring grip, Swivel Luer)

High-Viscosity agents: • Visipaque™ 320 (Iodixonal 320 mgl/mL) • Omnipaque™ 350 (Iohexol 350 mgl/mL) • Isovue™ 370 (Iopamidol 370 mgl/mL)

BOX 10

LV-EZ-RRS-10 DyeVert PLUS EZ Disposable Kit Contents: Module with Smart-Syringe (Ring Plunger-Ring grip, Swivel Luer)

Low-Viscosity agents: • Visipaque™ 270 (Iodixonal 270 mgl/mL) • Omnipaque™ 300 (Iohexol 300 mgl/mL)

BOX 10

R-RRS Smart-Syringe EA 1

Re-usable, provided NON-STERILE

Model No Description

CMW-US Wireless Display

References 1. Levine GN et al., ACCF/AHA/SCAI – Guideline for Percutaneous Coronary Intervention. A Report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation, 2011; 124:e574-e651. 2. Naidu, Srihari et al., SCAI Expert Consensus Statement: 2016 Best Practices in the Cardiac Catheterization Laboratory. Catheterization and Cardiovascular Interventions, 88:407–423, 2016.3. Desch, S. et al., Impact of a novel contrast reduction system on contrast savings in coronary angiography – The DyeVert™ randomised controlled trial,” Int J Cardiol (2018), https://doi.org/10.1016/j.ijcard.2017.12.107.4. Gurm H, Bertolet B, Kereiakes D, Mavromatis K, Rao S, Shah A, et al., A Multi-Center Observational Study of DyeVert™ Plus Contrast Reduction System [abstract]. Proceedings of the Society for Cardiovascular Angiography and Interventions 41st Annual Scientifi c Sessions. Catheterization and Cardiovascular Interventions. 2018;91(S2):S16. Best of the Best Poster Presentation Abstract no V-02.5. Mavromatis K., Editorial Comment: The Imperative of Reducing Contrast Dose in Percutaneous Coronary Intervention. JACC Cardiovasc Interv 2014;7:1294-1296.6. Gurm HS, Dixon SR, Smith DE et al., for the BMC2 Registry. Renal function-based contrast dosing to defi ne safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol 2011;58:907–14.7. Laskey WK, Jenkins C, Selzer F, et al., for the NHLBI Dynamic Registry Investigators. Volume-to-creatinine clearance ratio: a pharmacokinetically based risk factor for prediction of early creatinine increase after percutaneous coronary intervention. J Am Coll Cardiol 2007;50:584–90.8. Brown JR, Robb JF, Block CA et al., Does safe dosing of iodinated contrast prevent contrast-induced acute kidney injury? Circ Cardiovasc Interv 2010;3:346–50.

Osprey Medical5600 Rowland Road, Suite 250Minnetonka, MN USA 55343

www.ospreymed.com

Phone: 952.955.8230Fax: 952.955.8171

Customer Service Toll-FreePhone: 855.860.7584Fax: 855.883.4365customerservice@ospreymed.com

Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. Risks may include air emboli and infection.CAUTION: Federal (USA) lay restricts these devices to sale by or on the order of a physician.

MedPass International Limited, Windsor House, Bretforton, Evesham, Worcestershire, WR11 7JJ, Vereinigtes Konigreich

PRO146A0086

DyeVert, Osprey Medical, and Be Kind to Kidneys are trademarks of Osprey Medical, Inc. in the US and other countries. ©2018 Osprey Medical, Inc. All Rights Reserved.