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Inventors of the HeROTM Vascular Access Device

The HeROTM Vascular Access Device: A New Solution for the AV AccessChallenged Patient

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Learning Objectives

Upon completion of this p p p presentation, p , participants will p be able to:

Relate the significance of long-term catheter use to the increased rate of bacteremia, inadequacy of dialysis and i d t fb t i i d f di l i d risk of mortality in the catheter patient population 2. Summarize key results from the HeROTM Clinical Study y y 3. Recognize a HeROTM device implant patient 4. Describe the appropriate physical pp p p y assessment/cannulation technique of HeROTM patients and additional management considerations 5. 5 List characteristics of potential HeROTM candidates

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Outline

And I will do this by:

1. CPM data will be used to illustrate the growing prevalence of catheters and extrapolated to current HD data from 2008 USRDS data. KDOQI of 2006 goals will be reiterated. 2. Phase 3 clinical trial showing adequacy and infection data leading to FDA approval of this device as a graft 3. The i i i 3 Th 3 incisions that define a HeRO i l t will be described in th t d fi H RO implant ill b d ib d i detail along with history evidence 4. KDOQI 2006 graft cannulation guidelines will be reviewed along with the subtle physical assessment differences encountered ith th btl h i l t diff t d with HeRO 5.Clear inclusion and exclusion criteria will be given emphasizing that this i th t thi is not an access option for those patients who have AVF t ti f th ti t h h or AVG upper extremity options

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The Catheter Problem

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Patient Story

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The Catheter Problem: Growing Catheter Utilization

Time Period AVF Oct ­ Dec 20051 Oct ­ Dec 20062 54% 41% Incidence AVG 10% 13% CVC 36% 45% AVF 44% 45% Prevalence AVG 26% 26% CVC 27% 29%

12006 22007

ESRD CPM (Clinical Performance Measures) Project Table 9 ESRD CPM (Clinical Performance Measures) Project Table 9

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

The Catheter Problem: Growing Access Challenged Access-Challenged Population

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58% G Growth th

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The Catheter Problem: Bacteremia

Bacteremia is the second leading cause of hemodialysis patient death and catheters are the primary contributing factor · KDOQI reports an IJ catheter-related overall bacteremia rate of

1.6-5.5 per 1,000 catheter days1 catheter days2

· H ROTM clinical study used a li HeROTM li i l d d literature control of 2 3 per 1 000 l f 2.3 1,000 · Femoral cat ete bacte e a rates a e typ cally 2 t es higher3 e o al catheter bacteremia ates are typically times g e

1NKF

K/DOQI Clinical Practice Guidelines and Clinical Practice Recommendations 2006 Updates

2Oliver,

M., Lynch, L. Estimate of the Risk and Rate of Hemodialysis Catheter-Related Bacteremia. 2006. Hemosphere, Inc. document. (Hemosphere scientific literature review of prospective or randomized studies of tunneled IJ catheters (15 articles) with 20 patients or more). L. Dialysis Catheter Literature Summary. 2007. Hemosphere, Inc. document. (Hemosphere Scientific literature review of non-device related IJ/SCV catheter infections and device-related femoral catheter infections (4 articles)).

3Lynch,

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The Catheter Problem: Adequacy of Dialysis1

Type of Access AV Fistula AV Graft* Catheter

*iIncludes

Mean Kt/V

% of P i f Patients Kt/V<1.2 7% 4% 18%

% of P i f Patients Kt/V<1.3 14% 8% 30%

1.57 1.62 1.45

· 2006 KDOQI guidelines establish a mean Kt/V target of 1.4 · 30% of catheter patients had a delivered Kt/V less than 1.3, leaving

this patient population at risk for increased mortality

ESRD CPM Report. Adequacy of Hemodialysis Table 7.

grafts with and without AVFs

12007

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The Catheter Problem: Increased Patient Mortality

The mortality rate increases by 7% for each 0.1 unit decrease in Kt/V1

There is a 40% higher mortality rate for catheter g y patients compared to fistula patients2

1 Dhingra, g , 2

R., Young, E., Hulbert-Shearon, T., Leavey, S., Port, F. Type of Vascular Access and Mortality in the U.S. Hemodialysis Patients. Kidney International. , g, , , , y, , , yp y y y 2001. Vol 60, pp. 1443-1451 Pastan, S., et. al. Vascular access and increased risk of death among hemodialysis patients. Kidney International. 2002: 620-626

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The Catheter Problem: Summary

Catheter utilization is growing Number of patients who have exhausted all fistula and graft sites is growing High incidence of bacteremia is associated with longterm catheter use Measured Kt/V is lower in catheter patients Mortality rates are significantly higher in catheter patients compared to fistula patients

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The HeROTM Vascular Access Device Solution l

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Device Description HeRO

The HeROTM device is the new long term permanent HeRO long-term access solution for access-challenged and catheterdependent patients · Fully subcutaneous surgical implant · AV access with continuous outflow

into the central venous system

· Traverses central venous stenosis

allowing for long term hemodialysis access long-term

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Vascular Access Device

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Vascular Access Device Intended Use I t d d U & FDA Classification Cl ifi ti

The HeROTM is intended for use in maintaining longterm vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts The FDA classified the HeROTM device as a graft

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Right-Sided Implant Visual

Graft Component Dialysis Access Area Outflow Component Radiopaque Tip

Arterial Anastomosis

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Implantation: Step 1 p p

Venous Outflow Component p Placement · The outflow component is p

inserted into the IJV under ultrasound and fluoroscopic guidance and advanced into the mid to upper right atrium tunneled to connector i i i at t l dt t incision t the deltopectoral groove

· The outflow component is then

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Implantation: Step 2 p p

HeROTM Graft Tunneling g and Component Connection · The graft is tunneled from

the connector incision to the brachial artery incision y trimmed to size and connected to the graft component via the titanium connector

· The outflow component is

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Implantation: Step 3 p p

Arterial Anastomosis · The ePTFE graft

component is trimmed to size and the arterial anastomosis is completed procedure, fluoroscopy is used to reconfirm proper outflow component tip placement and absence of kinking with arm movement

· A the end of the At h d f h

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Titanium Connector

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Device Clinical Study

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

HeROTM Device Clinical Study: Overview

HeROTM Studies 86 total subjects

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Patency Study Enrollment started July `04

Bacteremia Study Enrollment started March `06

HeROTM 50 subjects

ePTFE Control 20 subjects

HeROTM 36 subjects

2:1 randomization Graft eligible subjects p 12 month follow-up

Non-randomized to literature control Catheter-dependent/poor venous outflow subjects 12 month follow-up

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

HeROTM Device Clinical Study: Demographics

Demographics D g hi Average years on dialysis Previous bacteremias Mean age (years) Caucasian African-American African American Hispanic Diabetes Mellitus HeROTM Bacteremia Study 5.1 ± 4.0 1.8 62.7 50.0% 36.8% 36 8% 13.2% 68.4% Prevalent Population P l tP l ti 5 yr life expectancy2 Not reported p 60.81 55.3%1 37.2% 37 2%1 14.8%1 42.9%1

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· Enrolled patients averaged over five years on dialysis and almost

70% of enrolled patients were diabetic

1U.S.

Renal Data System, USRDS 2007 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2007. Table 2. 2http://www.outcomes-trust.org/monitor/sum99mon.htm 13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

HeROTM Device Clinical Study: Access History

Access History Previous Fistula Previous Graft Previous Catheter % of Patients 66% 79% 100% Range of Prior Accesses 1-2 1-5 1 - 16

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· Enrolled patients had a mean of 5.4 prior vascular accesses

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Device Clinical Study Results: 70% Reduction in Bacteremia Rates

Analyzed C h t A l d Cohorts

HeROTM w/Bridging TDC (1,373 days) HeROTM Alone (8,525 days) HeROTM Overall (9,931 days) (9 931 d ) HeROTM Bacteremia B i Events 7 HeRO HeROTM Bacteremia Rate/1,000 days Catheter Literature Control/1,000 Days

5.1

1.6 ­ 6.91

0

0.0

2.34

7

0.7 07

2.3 2 32

· 59% of patients with a bridging TDC had a femoral catheter · NO d i device-related b t l t d bacteremia events were reported after b id i catheter i t t d ft bridging th t

was removed

1Combined 2Oliver Oliver,

bacteremia rate range for femoral and IJ TDCs; IJ TDC range from 2006 K/DOQI Guidelines and femoral TDC range from Lynch, L. Dialysis Catheter Literature Summary. 2007. Hemosphere, Inc. document

M Lynch L Estimate of the Risk and Rate of Hemodialysis Catheter-Related Bacteremia. 2006 M., Lynch, L. Bacteremia 2006. Hemosphere, Inc. document

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

HeROTM Device Clinical Study Results: Patency

Patency HeROTM Bacteremia Study Patency at 6.8 HeROTM Months 44.4% Catheter Literature Patency at 6 Months1 50% Graft Literature Patency at 6 Months1 58%

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Primary Patency

Secondary Patency Functional Patency

100.0% 72.2%

55% Not Reported p

76% Not Reported p

· No devices were removed due to patency during the study · Loss of functional patency refers to devices abandoned due to

reasons other than patency

1Lucas, 2One

G. Scientific Literature Review for Primary, Primary-Assisted and Secondary Patency in Hemodialysis Catheters and Grafts. 2007. Hemosphere, Inc. document clinically hypercoagulable subject excluded from this analysis

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Device Clinical Study Results: Adequacy of Dialysis

HeROTM Bacteremia Study (N=36) Catheter Literature2 Graft Literature2 KDOQI Adequacy of Hemodialysis Guidelines1

Kt/V (mean)

1.7

1.29 ­ 1.46

1.37 ­ 1.62

1.4 Target

· · ·

12006

HeROTM device blood flow rates comparable to a graft Exceeds KDOQI target Kt/V by 0.3 Each 0 1 decrease i K /V = 7% i E h 0.1 d in Kt/V increase i mortality rate in li

K/DOQI ­ Clinical Practice Guidelines for Hemodialysis Adequacy Guideline 4. Minimally Adequate Hemodialysis G. Scientific Literature Review for Hemodialysis Adequacy Reporting Methods and Results 2007. Hemosphere, Inc. document

2Lucas,

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The HeROTM Device Clinical Study: Summary

Primary endpoint to reduce bacteremia was met! · 70% reduction in device/procedure-related bacteremia

compared to catheter literature control p

1.7 mean Kt/V exceeded the KDOQI target for adequate dialysis y · Significantly improved vs. the catheter literature control No devices were removed due to patency issues · Although the HeROTM device may require declot intervention

similar to a graft

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Clinical Investigational Sites

Investigators I ti t

Marc Glickman, MD (PI) John Ross MD (PI) Ross, Jeffrey Lawson, MD Howard Katzman, MD Robert McLafferty, MD Colleen Johnson, MD Kevin Croston, MD Jeffrey Martinez, MD Eric Peden, MD Joseph Zarge MD Zarge,

Sites Sit

Sentara Hospital Bamberg County Hospital Duke University Medical Center Univ. of Miami Hospital Southern Illinois University North Memorial Medical Center Baptist Medical Center Baylor Medical Center St. Joseph s St Joseph's Hospital

Locations L ti

Norfolk, VA Bamberg, Bamberg SC Raleigh-Durham, NC Miami, FL Springfield, IL Robbinsdale, MN San Antonio, TX Houston, TX Atlanta, Atlanta GA

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Recognizing HeROTM Device Patients

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Recognizing HeRO Device Patients HeROTM

Look for three incisions:

· Internal jugular incision · Deltopectoral groove incision

(palpate for device connector) l f d

· Brachial artery incision y

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Recognizing HeRO Device Patients HeROTM

HeRO HeROTM identification items are provided in the implant kit for the patient to receive post-procedure · Identification Information Card · Patient Information Handbook · HeROTM Wristband · P id Care & Management Brochure Provider C M B h · Implant Notification Fax Form

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Device Care & Cannulation

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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AVG Physical Assessment: L k Listen & F l Look, Li t Feel

Look

· Uniform sized graft · No irregular areas or aneurysm formations · Organized cannulation site rotation · Low pitch continuous diastolic and systolic · HeROTM bruit may be slightly softer due to absence HeRO

of venous anastomosis

Listen

Feel

· Thrill and/or pulse strongest at the arterial · ·

anastomosis, but should be felt over the course of the entire graft Easy to compress HeROTM thrill may also be less prominent

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Device Cannulation HeRO

Follow KDOQI Guidelines for cannulation: · Wait until swelling has subsided so the course of the graft can

be palpated (at least two weeks prior to first cannulation)

· Use standard fistula needles at a 45-degree angle · Rotate cannulation sites · Stay 2-3 cm from the arterial anastomosis 23

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Techniques for AVG Cannulation q

Technique

For routine AVGs: · Advance the needle slowly with the beveled cutting edge up facing the top of the vessel · Do not rotate the axis · Any manipulation may traumatize the vessel intima

Rationale

For deep, hard to palpate AVGs: · Immediately rotate the axis of the needle 180o · Advance needle slowly with the beveled y cutting edge down facing the bottom of the vessel

· Rotating the axis avoids traumatizing the top of the intima · Prevents the needle tip from entering the backside of the graft material · This should only be utilized when the graft back-wall location is difficult to determine and the risk of continuing needle advancement into the back-wall is high

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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AVG Cannulation Needle Handling g

Technique Rationale

· Pressing the needle shaft flat against the skin moves the tip from the desired position within the vessel lumen · Any needle manipulation may traumatize the vessel intima · Avoid pressing the cutting edge of the needle into the intima when applying pressure for hemodialysis y

· Tape the needle at the angle insertion · Remove the needle at the angle of insertion · Never apply pressure before the needle is completely removed

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Additional Considerations For H ROTM Device C l ti HeROTM D i Cannulation

Stay at l S least 3 i h f inches from the connector i i i site h incision i Never puncture the outflow component

Tourniquet may be beneficial to dilate graft Hemostasis post dialysis should be achieved using digital pressure rather than fistula clamps Remove bridging catheter following successful g g g HeROTM device cannulation

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Healthcare Economics

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The Catheter Problem: Hi h Cost to the H lth High C t t th Healthcare S t 1 System

Bacteremia/septicemia is a significant complication requiring hospital admission in hemodialysis patients $23,451 is the mean cost of a catheter-related bacteremia hospitalization · 17 day mean length of stay · MRSA bacteremia associated with longer stays and higher costs

1Ramanathan

V., Chiu, E.J., Thomas, J.T., Khan, A., Dolson, G.M., Darouicher, R.O. Healthcare Costs Associated with Hemodialysis

Catheter-Related Infections: A Single-Center Experience. Infection Control Hospital Epidemiology. 2007 May; 28(5):606-9.

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Potential Healthcare Savings g

TDC Costs HeRO HeROTM Device Costs2 $4,006 $6,307 $ , $5,991 $16,304 HeROTM Device Savings

Implant Procedure Maintenance Procedures (yearly) Bacteremia Hospitalization (yearly)1 Total

$1,4661 $4,256 $ , $19,699 $25,421

($2,540) ($2,051) $ , $13,708 $9,117

· Converting 20,000 catheter patients to HeROTM devices could result

in a potential healthcare system savings of ~$182 million

1R Ramanathan V Chi E.J., Thomas, J.T., Khan, A., Dolson, G.M., Darouicher, R.O. Healthcare Costs Associated with th V., Chiu, E J Th J T Kh A D l GM D i h R O H lth C t A i t d ith Hemodialysis Catheter-Related Infections: A Single-Center Experience. Infect Control Hosp Epidemiology. 2007 May; 28(5):606-9. 2

Economic analysis on file at Hemosphere, Inc.

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Identifying HeROTM Device Candidates

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Device Candidates HeRO

HeRO HeROTM is ideally suited for the large and rapidly growing number of hemodialysis p patients who are:

· Catheter-dependent ·A Approaching catheter-dependency hi th t d d · Failing an existing fistula or graft due to venous

outflow obstruction or central venous stenosis

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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HeROTM Candidate Selection Criteria HeRO

Follow KDOQI guidelines for vessel mapping to evaluate patient qualifiers necessary for HeROTM device placement

Necessary Patient Qualifiers: > 3 mm brachial artery Adequate cardiac function (ejection fraction > 20%) Systolic BP > 100 mmHg Infection free Without ipsilateral PM/IADC

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Introducing HeROTM Into Your Access Program g

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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What Will HeROTM Do For Your Patients d Your V l Access P ? and Y Vascular A Program?

Positively impact the overall health and quality of life for your access-challenged patients · Significantly reduce catheter-related bacteremia · Improve adequacy of dialysis over catheters · Reduce complications experienced with a catheter Lower your percentage of catheter-dependent patients Simplify staffing p p y g patterns related to care of catheter patients

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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What Happens Now?

Review your current catheter-dependent patients to determine eligibility li ibilit Work with your HeROTM representative to assist in educating the nephrologists and vascular surgeons

Vascular Access Surgeon

Hemodialysis Center C t Patients

Access Coordinator/ Nephrologist Referral

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Summary of HeROTM Device Management

The HeRO device is the only long-term, peripheral AV access HeROTM long term, option for patients with venous outflow obstruction Employ strict infection control procedures as per CDC dialysis precautions to keep HeROTM patients free from the risks of infection Keep in mind this patient population may require longer than 14 days for tissue to graft incorporation Timely removal of the bridging TDC following successful HeROTM device incorporation will likely decrease the risk of catheterrelated infections

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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The HeRO as I see it!

HeRO is not for everybody but it might be just the right device for that patient who has: · Good brachial flow · Compromised venous outflow · No other peripheral access options

AND ..................................................................

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Remember R b It's Always about what is best for the individual Patient!

13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

References and Resources

Dinwiddie, L.C. (2008). Vascular access for hemodialysis. In C. Counts (Ed.), Core Curriculum for Nephrology Nursing (5th ed). Pgs 735-764. ANNA, Pitman, NJ, PA. National Kidney Foundation. KDOQI Clinical Practice Guidelines for Foundation Vascular Access: update 2006. (2006) American Journal of Kidney Diseases, 48(1), S176-S307. Burrows-Hudson S., Prowant, B. (2005). Burrows Hudson S & Prowant B (2005) Nephrology nursing standards of practice and guidelines for care. Pitman, NJ: American Nephrology Nurses Association.

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Questions & Answers

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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