PreSep Oximetry Catheter

The security of an early warning

Convenient, accurate and easy to use

• The first proven central venous catheter with continuous ScvO2 monitoring

• Accurate versus CO-oximeter7

• Simple to use—same insertion techniques as that of a central line

PreSep Oligon Oximetry Catheter*with integrated antimicrobial protection

The PreSep oximetry catheter. The proactive decision.

In the critically ill, traditional vital signs may be late indicators of compromised or inadequate oxygen delivery to the

tissues. By providing a real-time, global measure of oxygen balance, the PreSep oximetry catheter detects critical changes

earlier—enabling you to detect and prevent tissue hypoxia sooner.1-5

Continuous ScvO2 monitoring is key to assessing the adequacy of the balance of oxygen delivery and consumption.

The goal of continuous ScvO2 monitoring with the PreSep oximetry catheter is to bring into balance the relationship

between oxygen delivery and consumption to improve the care of high-acuity patients.6

PreSep Oximetry Catheter

ScvO2

Clinical applications of ScvO2

ScvO2 and SvO2 are affected by the same four factors and trend together more than 90% of the time. Thus, most of

the research and clinical applications documented for SvO2 should apply to ScvO2. Figure 1 provides examples of clinical

situations where ScvO2 monitoring may be helpful in identifying imbalances between DO2 and VO2.13

The proven advantage of continuous ScvO2 monitoring.

Continuous ScvO2 monitoring is proven to reduce mortality,

comorbidities, hospital costs and length of stay when compared

to intermittent sampling. The prognostic value of ScvO22 has been

demonstrated in high-risk surgery,8 trauma,4 sepsis,2,9 cardiac failure

in CHF6,7 and recovery in cardiac arrest.10,11

•Continuous ScvO2 is a more sensitive indicator of tissue perfusion

compared to intermittent sampling and traditional vital signs alone1-5

• Continuous ScvO2 monitoring reveals the true adequacy of tissue

oxygenation, enabling early detection and assessment of clinical

response to intervention1,2

• Continuous ScvO2 highly correlates and trends with SvO21-5 while

providing the same utility in monitoring, which is essential in defining

the adequacy of cardiac output12

Source: Effect of intermittent vs. continuous ScvO2

monitoring on sepsis bundle compliance and mortality. Am Coll Chest Physicians. 2009.15

Decrease in patient mortality rate

26.5%

ContinuousScvO2 monitoring

Intermittentmonitoring

38.7%

ContinuousScvO2 monitoring

Intermittentmonitoring

75.7%

60.3%

Increase in patients reaching six-hour goal

Advantages of Continuous ScvO2

Outcomes using continuous central venous

oxygen saturation versus standard central

venous catheters in sepsis management.

• Reduction in total hospital charges of $82,262 per case

• Decrease in hospital length of stay by 7.48 days

Source: Comparison of continuous central venous oxygen saturation and standard central venous catheters in septic patients at a large, non-academic tertiary medical center. Crit Care Med. 2009;37(12) (suppl).14

CARDIAC OUTPUT

HypovolemiaLeft Ventricular Failure

CHF • PacingHigh CO - Early SepsisLow CO - Late Sepsis

HEMOGLOBIN

Bleeding • Internal BleedingCoagulopathies • Transfusion

OXYGENATION

VentilationOxygenation

Failure to Tolerate Extubation

O2 CONSUMPTION

Burns • FeverShivering • Seizures

Work of Breathing • Sepsis

ScvO2

The PreSep oximetry catheter, from Edwards Lifesciences.

The security of an early warning. For clarity, in every moment.

Figure 1

Edwards Lifesciences LLC • One Edwards Way • Irvine, CA 92614 • USA • 949.250.2500 • 800.424.3278 • www.edwards.com

Edwards Lifesciences (Canada) Inc. • 1290 Central Pkwy West, Suite 300 • Mississauga, Ontario • Canada L5C 4R3 • 905.566.4220 • 800.255.3993

Edwards Lifesciences SA • Route de l’Etraz 70 • 1260 Nyon • Switzerland • 41.22.787.4300

Edwards Lifesciences Ltd. • 6-10-1 Nishi-shinjuku • Shinjuku-ku, Tokyo 160-0023 • Japan • 81.3.6894.0500

FloTrac Sensor

The FloTrac sensor is the easy and reliable

solution for optimizing fluid

management. Less invasive and easily

attaches via any standard arterial catheter,

the FloTrac sensor gives you access to

continuous cardiac output, stroke volume,

stroke volume variation and systemic

vascular resistance—under numerous patient

conditions. When combined with the

continuous ScvO2 monitoring of the PreSep

oximetry catheter, you’ll also find a clear

path to improving sepsis patient outcomes.

Visit www.Edwards.com/PreSep to learn more

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.

References: 1. Reinhart K, et al. Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care Med. 2004;30(8):1572-8. 2. Rivers EP, et al. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care. 2001;7(3):204-11.3. Ingelmo P, et al. Importance of monitoring in high risk surgical patients. Minerva Anestesiol. 2002;68(4):226-30. 4. Scalea TM, et al. Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma. 1990;30(12):1539-43.5. Ander DS, et al. Undetected cardiogenic shock in patients with congestive heart failure presenting to the emergency department. Am J Cardiol. 1998;82(7):888-91. 6. Loren D. Continuous venous oximetry in surgical patients. Ann Surg. 1986;203/3:329-333.7. Edwards, Vigileo Operators Manual: A-4.8. Pearse R, et al. Changes in central venous saturation after major surgery, and association with outcome. Crit Care. 2005;9(6):R694-9. 9. Rady MY, et al. Resuscitation of the critically ill in the ED: responses of blood pressure, heart rate, shock index, central venous oxygen saturation, and lactate. Am J Emerg Med. 1996;14(2):218-25. 10. Nakazawa K, et al. Usefulness of central venous oxygen saturation monitoring during cardiopulmonary resuscitation. A comparative case study with end-tidal carbon dioxide monitoring. Intensive Care Med. 1994;20(6):450-1.11. Rivers EP, et al. The clinical implications of continuous central venous oxygen saturation during human CPR. Ann Emerg Med. 1992;21(9):1094-101. 12. Pinsky MR, et al. Let us use the pulmonary artery catheter correctly and only when we need it. Crit Care Med. 2005;33(5):1119-22. 13. Zaja J. Venous oximetry. Singa Vitae. 2007;2(1):6-10.

14. Maxwell D, et al. Comparison of continuous central venous oxygen saturation and standard central venous catheters in septic patients at a large, non-academic tertiary medical center. Crit Care Med. 2009;37(12) (suppl). 15. Ising P, et al. Effect of intermittent vs. continuous ScvO2 monitoring on sepsis bundle compliance and mortality. Am Coll Chest Physicians. 2009. *PreSep Oligon oximetry catheters contain an integrated Oligon antimicrobial material. The activity of the antimicrobial material is localized at the catheter surfaces and is not intended for treatment of systemic infections. In vitro testing demonstrated that the Oligon material provided broad-spectrum effectiveness (≥ 3 log reduction from initial concentration within 48 hours) against the organisms tested: Staphylococcus aureus, Staphylococcus epidermidis,Klebsiella pneumoniae, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diphtheriae, Enterobacter aerogenes, GMRSa, Pseudomonas aeruginosa, Candida glabrata and VRE (Enterococcus faecium).

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, FloTrac, PreSep and Vigileo are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.Oligon is a trademark of Implemed, Inc. Early Goal-Directed Therapy and EGDT are trademarks of Dr. Emanuel Rivers. IntelliVue is a trademark of Phillips Healthcare.©2010 Edwards Lifesciences LLC. All rights reserved. AR05216

Vigileo Monitor

The Vigileo monitor displays advanced,

minimally invasive hemodynamic

management information. This monitor

works with the FloTrac sensor, as well as

PreSep and PediaSat oximetry catheters.

Compact and stackable, the Vigileo

monitor is the simple solution for the OR

and ICU.

Philips IntelliVue SO2 Module

The Philips IntelliVue SO2 module allows

continuous ScvO2 monitoring from the

PreSep or PediaSat oximetry catheters

to be displayed on the Philips IntelliVue

MP40 to MP90 patient monitors.

Helping to advance the care of the critically ill for 40 years, Edwards Lifesciences seeks to provide the valuable information you need, the moment you need it. Through continuing collaboration with you, ongoing education and our never-ending quest for advancement, our goal is to deliver clarity in every moment.

For professional use. For additional information, indications, contraindications, warnings, precautions and adverse events, please refer to the Instructions For Use provided with the products.