guidebook - rtg shows to gortgshowstogo.com/wp-content/uploads/2017/09/asn...• crit-line...

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KIDNEY WEEK

GUIDEBOOK

ASN KIDNEY WEEK 2017

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Table of Contents

Compliance..................................................................................................1

In-Center Technologies 2008T Hemodialysis Machine...................................................................2 bibag® On-Line Dry Bicarbonate Concentrate..............................................3 CombiSet® True Flow Series Bloodlines.......................................................4 Crit-Line® Technology...............................................................................5 Optiflux® High Flux and Low Flux Ebeam Series Dialyzers............................6

Home Therapies Commitment to Home..............................................................................7

Peritoneal Dialysis Knoxville Facility......................................................................................8 Liberty® Select Cycler...............................................................................9 Liberty Modem......................................................................................10 Next Generation PD Cycler ....................................................................11 PD Plus™ Therapy...................................................................................12 stay•safe® Connectology.........................................................................13

Home Hemodialysis 2008K@home™ Hemodialysis Machine...................................................14

Pharmaceuticals Velphoro® (Sucroferric Oxyhydroxide) Tablets............................................15 Venofer® (Iron Sucrose Injection, USP)......................................................16

Additional Resources Exhibit Hall and Booth Layouts.................................................................17 Booth Contacts.......................................................................................19


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ASN KIDNEY WEEK 2017 1

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Compliance

IntroductionCompetitors, government officials, and potential customers attend tradeshows and conferences. The following information is intended to highlight a few points to remember while representing Fresenius Medical Care Renal Therapies Group (“RTG”) at these events. Refer to applicable policies for additional details.

In the booth• Separate Commercial and Scientific/Medical engagement and displays. It is important

for these areas to remain clearly separate while the floor is open. Employees and materials must remain in their designated areas.

• Be consistent with the labeled indications for RTG products. Only Medical may answer unsolicited off-label questions.

• Preserve confidentiality. Don’t discuss specific patient information (PHI).• Keep RTG materials free of writing, highlighting, and sticky notes.• Only ASN-approved RTG materials should be in the RTG booth. Materials for other

Fresenius Medical Care business lines must remain in their booths.

Beyond the booth• Make sure RTG internal tradeshow documents and electronic devices are in a safe place.

They may contain confidential company information.• Don’t discuss RTG confidential information in a public space (e.g., restrooms, elevators,

hotel lobby). You never know who's listening.• If you are permitted, based on your role in RTG, to provide meals to non-RTG attendees,

make sure you have a bona fide business reason for providing a meal; appropriately document the expense, and spend within policy limits. Remember, meal limits include tax, tip, and beverages.

• Provision of gifts or entertainment to customers or potential customers is prohibited.

For more information, refer tradeshow attendees to:• Alexis Wermuth


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In-Center Technologies

2008T Hemodialysis Machine

What is it?• An in-center hemodialysis machine

What should people know about it?• Built on three decades of Fresenius Renal Technologies’ leadership• Features and user interface selected by most U.S. facilities• Proven reliability and durability• Largest pool of trained and experienced staff in the industry

Key features include:• Clinical Data eXchange™ (CDX), chairside access to dialysis treatment and medical

information system• bibag® on-line dry bicarbonate concentrate system• Integrated Crit-Line® Fluid Management Technology• On-Line Clearance Monitor that provides real-time, visual assessment of

treatment adequacy• Automatic heat disinfection

For more information, refer tradeshow attendees to:• Michael Singer


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bibag® On-Line Dry Bicarbonate Concentrate

What is it?• On-line dry bicarbonate concentrate

What should people know about it?• Sodium bicarbonate powder is automatically mixed with water, producing a saturated

bicarbonate concentrate directly on the machine• Available on the 2008T and 2008K@home™ hemodialysis machines

Key features include:• 650 g and 900 g bag sizes• Convenient handling and space saving vs. liquid bicarbonate

For more information, refer tradeshow attendees to:• Stephen Jaquith


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CombiSet® True Flow Series Bloodlines

What is it?• Bloodlines for 2008® series hemodialysis machines

What should people know about it?• Made with specially blended polymers and advanced extrusion technology to withstand

the stresses of hemodialysis treatment, while delivering blood to the dialyzer at an accurate and consistent rate

• Designed to perform optimally with our 2008 series machines• Available in a wide range of configurations including pre-pump, post-pump, home

hemodialysis, low volume, blood volume monitoring, and single needle• Only available in North America

Key features include:• Twister® reverse flow device

o Designed to complement our 2008 series machines with built-in On-Line Clearance (OLC) software

o Closed-system design reverses blood flow without the need for manual reversal of bloodlines, reducing the potential for blood exposure and accidental contamination

o Can be an effective and simple solution for a vascular access surveillance program

For more information, refer tradeshow attendees to:• Robert Reid or Joanie Werner


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Crit-Line® Technology

What is it?• Crit-Line® technology uses an optical sensor to monitor blood-volume percent changes

in real-time, so caregivers can adjust dialysis treatment as necessary to maximize fluid removal and prevent common complications of dialysis, such as nausea, vomiting and cramping.

What should people know about it?• Crit-Line technology is offered as an integrated module in the 2008T machine (CLiC™),

or as a stand-alone device (Crit-Line IV) offered for use with other 2008 series HD machines or competitive HD equipment.

• RTG offers a variety of upgrade and trade-in options for Crit-Line III monitors

Key features include: Real-time access to the following key data points:

• Initial Hct• Initial Hbg• Current Hct• Current Hbg• Current O2 Sat• Minimum O2 Sat• Current BV% change• BV alert Level (if set)• O2 Alert Level (if set)

For more information, refer tradeshow attendees to:• Matt Haynie or Mike Black


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Optiflux® High Flux and Low Flux Ebeam Series Dialyzers

What are they?• Single-use dialyzers

What should people know about them?• #1 prescribed dialyzer brand in the U.S. • More than 450 million treatments strong• Attendees can learn more at the dialyzer kiosk in the booth

Key features include:• We are 100% committed to single-use• We no longer produce reuse dialyzers in the U.S.• Single-use dialyzers eliminate patient exposure to reuse reprocessing chemicals and the

risk of decreased dialyzer performance with subsequent reuse • Can conveniently be used in the arterial upright or inverted position

For more information, refer tradeshow attendees to:• Joanie Werner


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Home Therapies

COMMITMENT TO HOME

What is it?• Renal Therapies Group is dedicated to demonstrating its commitment to home therapies• Points of progress showcasing this commitment are featured throughout the

Home Therapies booth

What should people know about it?Points of progress highlighted at the show include:

• Launch of the new Liberty® Select cycler, an improved model of the Liberty cycler which addresses customer feedback with its new features

• Opening of the new Knoxville, TN facility, to increase peritoneal dialysis (PD) solution bag availability

• New Debiotech partnership, to fuel the delivery of miniature PD machines• Planned acquisition of NxStage Medical, to expand access to home hemodialysis (HHD)

Key features include:• Home Therapies “commitment” booth graphic featuring “points of progress”• Awareness campaign with hot air balloon graphic, highlighting our commitment to going

above and beyond the expected for patients and the people who care for them

For more information, refer tradeshow attendees to:• Jehana Ray


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Peritoneal Dialysis

KNOXVILLE FACILITY

What is it?• New PD manufacturing facility

What should people know about it?• Scheduled to open in Knoxville, TN by the end of 2017• Will increase the national PD solution supply and complement RTG's existing

Utah-based facility • Demonstrates RTG’s commitment to support long-term PD market growth • East coast distribution to serve 75% of PD population with one-day drive

Key features include:• 280,000 sq. ft. with expansion capacity of 400,000 sq. ft.• Fully automated

For more information, refer tradeshow attendees to:• Meghan Wright


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LIBERTY® SELECT CYCLER

What is it?• The latest software upgrade to the Liberty® cycler franchise

What should people know about it?• Provides users with additional, selectable options for customizing their treatment for

a better drain experience • Other new features (e.g., soft alarm) provide added comfort and convenience for the

patient to ensure a restful night’s sleep • Recently approved by the FDA, commercial roll-out began in the last week of

October 2017

Key features include:• Selectable options that provide a better drain experience, including:

o STAT drain at the end of treatmento Selectable drain exit criteriao Additional drain options

• Soft alarm that gently notifies patients when the patient line becomes blocked during treatment

• Quality improvement upgrades that reduce nuisance alarms• Enhanced screen updates for more detailed instructions

For more information, refer tradeshow attendees to:• Stephen Flores, Rhonda Duggan, or any member of the PD marketing team


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LIBERTY MODEM

What is it?• External modem that attaches to the Liberty cycler to provide connectivity for daily

treatment downloads to Fresenius Kidney Care (FKC) clinics

What should people know about it?• Provides clinicians with daily treatment data, so they can support their patients with timely

interventions to improve treatment outcomes and increase the length of stay in the modality• Currently available only to FKC clinics• New patients from wholly owned FKC clinics automatically get the modem with the cycler

order, while joint venture clinics are offering this as an option • Over 4,000 modems already deployed in the FKC clinics; more than half are actively

transmitting data to their eCube system

Key features include:• Current deployment uses the 2G Verizon modem• With the roll-out of Liberty Select, more modem options will be provided for better

coverage, including 4G AT&T and 4G Verizon

For more information, refer tradeshow attendees to:• Stephen Flores, Rhonda Duggan, or any member of the PD marketing team


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NEXT GENERATION PD CYCLER

What is it?• A new automated peritoneal dialysis (APD) cycler we’re developing, designed to keep

patients and clinicians connected and confident

What should people know about it?• This product is pending 510(k) clearance and is not available for sale in the U.S. Also,

since the FDA prohibits pre-approval promotion, this device CANNOT be discussed with customers or anyone outside of the Fresenius Medical Care Renal Therapies Group.

• We believe home therapy options are critical for patients and we intend to continue to innovate on both the hemodialysis and PD side

• We are excited about the partnership we’ve entered with Debiotech for the development of our future APD technologies.

• Debiotech is a Swiss medical device developer with expertise in innovative technologies and miniaturized medical devices.

For more information, refer tradeshow attendees to:• Jehana Ray or Teresa Close


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PD PLUS™ THERAPY

What is it?• A therapy option, available for use with the Liberty Select cycler, that may be used

instead of icodextrin

What should people know about it?• Designed in 1996 by PD pioneer Dr. Jose Diaz-Buxo• Hybrid therapy with an extra exchange that can enhance clearance and ultrafiltration1 • Doesn’t require the use of additional solution types2

• Can allow for a continuous, around-the-clock regimen, in accordance with the International Society of Peritoneal Dialysis’ recommendations3

• Option for anuric and larger body patients who have difficulty achieving their target Kt/v1

• May be a more cost-effective option compared to the use of icodextrin

For more information, refer tradeshow attendees to:• The Medical Information booth

1 Diaz-Buxo JA: Enhancement of peritoneal dialysis: the PD Plus concept. Am J Kidney Dis 1996;27(1):92-982 Diaz-Buxo JA: Continuous cycling peritoneal dialysis, PD Plus, and high-flow automated peritoneal dialysis: a spectrum of therapies. Perit Dial Int 2000;20 (Suppl 2):S93-73 Blake PG, et al: Clinical practice guidelines and recommendations on peritoneal dialysis adequacy 2011. Perit Dial Int 2011;31(2):218-239


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stay·safe® Connectology

What is it?• Our proprietary connectology for both automated peritoneal dialysis (APD) and

continuous ambulatory peritoneal dialysis (CAPD) therapy

What should people know about it?• Celebrated 20 years in the global market last year• Launched in the U.S. in 2004• Currently used by approximately 20,000 patients

Key features include:• Designed for easy, effective, and efficient training and therapy management• PIN technology closes catheter extension set and fluid pathway before disconnection,

which helps reduce the potential risk of touch contamination • 50% fewer CAPD system openings vs. competition• Simple to perform treatment correctly every time

For more information, refer tradeshow attendees to:• Meghan Wright or another member of the PD marketing team


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Home Hemodialysis

2008K@home™ Home Hemodialysis Machine

What is it?• A home hemodialysis machine

What should people know about it?• Built on 30 years of Fresenius Renal Technologies’ hemodialysis leadership. • Is proven to be highly reliable, durable, and flexible • Is backed by the industry’s most extensive array of support services • Offers convenient delivery of supplies to the therapy location in the patient’s home • Makes it easier to go home with confidence

Key features include:• WetAlert™ wireless wetness detector • bibag® on-line dry bicarbonate concentrate system • User-friendly touchscreen designed for the home patient

For more information, refer tradeshow attendees to:• Ed Auzenbergs


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Pharmaceuticals

Velphoro® (Sucroferric Oxyhydroxide) Tablets

What is it?• Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control

of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

What should people know about it?• Different results require a different approach to phosphate management• Velphoro real-world data shows that switching to Velphoro makes a world of difference• Join us for at booth #719 for our exciting “Velphoro Targets Phosphate”

interactive experience

Key features include:• Sustained Kidney Disease Outcomes Quality Initiative (KDOQI) target levels with

3-4 tablets/day• High potency allows for a low pill burden • Flexible administration helps patients take their binders as prescribed• In a real-world study, double the percentage of patients achieved their phosphorous

level goal with half the pills

For more information, refer tradeshow attendees to:• Donna St. Pierre


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Venofer® (Iron Sucrose Injection, USP)

What is it?• Venofer® (iron sucrose injection, USP) is an intravenous iron used to treat iron deficiency

anemia in dialysis patients with chronic kidney disease (CKD).

What should people know about it?• IV iron is a critical component of anemia management• Venofer is the #1 prescribed IV iron in the U.S. and is currently used in more than 79

countries• Venofer has well-established performance worldwide more than 65 years

Key features include:• Venofer is approved to treat a wide range of the dialysis patient population

o Adult home hemodialysis (HHD) patients with intolerance to iron dextran, ferric gluconate or both

o Adults: Hemodialysis dependent-CKD (HDD-CKD), peritoneal dialysis dependent-CKD (PDD-CKD)

o Pediatric patients on maintenance therapy only - ≥2 years of age, on erythropoietin (EPO): HHD-CKD, PDD-CKD

• No dextran or modified dextran• No black box warning • No test dose required in U.S.

For more information, refer tradeshow attendees to:• Carlos DelSalto


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Booth Layouts

Page 1FMCNA Proprietary and Confidential Information.

Renal Technologies – Booth 1000

Coffee Hospitality

Websites & e-Lit

MedicalInformation

Welcome

Scientific LibraryInteractive Area

Interactive Challenge Tables

Signage Promoting Booths

Storage

Dialysis Kiosk

DoubleSided bibagKiosk

2008T machine with CLiCtechnology & bibag and CritLine IV monitor

Fluid Management Interactive Wall

Liberty Select cycler and stay·safesystem

Liberty Select cycler

2008K@home machine

Patient/Caregiver interactions

Page 2FMCNA Proprietary and Confidential Information.

Renal Pharmaceuticals – Booth 719

Home Dialysis In-Center Dialysis

Hospitality

Bar Height Seating

MedicalInformation

Velphoro

Venofer

Kinect Challenge

Double Sided Lightbox

Storage

Velphoro

Velphoro

Kinect Challenge

Kinect Challenge

Kinect Challenge


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Booth Contacts

Name Booth Contact for… Cell Phone Email Address Number

Aaron Pike General Tradeshow Questions and Needs 323-229-8368 [email protected]

Alexis Wermuth Compliance Questions 781-775-9892 [email protected]

Carlos DelSalto Venofer 954-604-0285 [email protected]

David Parry General Tradeshow Questions and Needs 480-262-0674 [email protected]

Donna St. Pierre Velphoro 401-487-2046 [email protected]

Ed Auzenbergs Home Hemodialysis 508-523-2936 [email protected]

Jehana Ray Home Therapies Awareness Campaign, 781-530-6842 [email protected] Next Generation PD Cycler

Joanie Werner Dialyzers, Bloodlines 781-799-4039 [email protected]

Marcia Ouellette General Tradeshow Questions and Needs 603-247-3129 [email protected]

Matt Haynie Crit-Line Technologies 801-550-5364 [email protected]

Meghan Wright Knoxville Facility, stay·safe Connectology 617-930-1496 [email protected]

Michael Singer In-Center HD Machines 617-930-6394 [email protected]

Mike Black Crit-Line Technologies 801-390-8311 [email protected]

Monica Straub Liberty Select cycler, Liberty modem 314-614-9038 [email protected]

Rhonda Duggan Liberty Select cycler, Liberty modem 704-292-0526 [email protected]

Robert Reid Bloodlines 781-460-7772 [email protected]

Stephen Flores Liberty Select cycler, Liberty modem 617-281-7866 [email protected]

Stephen Jaquith Concentrates 339-927-0805 [email protected]

Teresa Close Next Generation PD Cycler 281-727-6336 [email protected]

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© 2017, Fresenius Medical Care, All Rights Reserved. Fresenius Medical Care, the triangle logo, Fresenius Renal Therapies Group, Fresenius Renal Technologies, Fresenius Renal Pharmaceuticals, Liberty, Liberty Select, PD Plus, stay·safe, 2008, 2008K@home, WetAlert, Clinical Data eXchange, bibag, CombiSet, Twister, CLiC, Optiflux, and Crit-Line are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. Velphoro is a registered trademark of Vifor Fresenius Medical Care Renal Pharma Ltd. Venofer is manufactured under license from Vifor (International) Inc. and used by permission. All other trademarks are the property of their respective owners. P/N 103414-01 Rev A 10/2017

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