Discharge with confidencePREVENA RESTOR ARTHRO•FORM™ INCISION MANAGEMENT SYSTEM

PRE-VALUE ANALYSIS COMMITTEE BROCHURE

Orthopedic surgery has a unique set of challengesToday’s environment of value-based care requires providers to constantly refine their practice

5.4%The 30-day readmission rate across all orthopedic specialties1

Healthcare providers are continually facing new hurdles

You need new tools to support your surgical technique and post-op rehab protocol

Surgeons now assume the risk for patient rehabComplications that lead to readmissions are not reimbursed

Total joint arthroplasty procedures are increasingly becoming same-day discharge

Medicare has removed total knee anthroplasty from its inpatient only list and plans to remove additional joint procedures in future years

Patient experience is more important than everOnline reviews and referrals impact volume

ConsequencesIssues

“ The subset we worry about the most are those that decide on their own that [edema] is a problem, despite us doing our best to educate them. They end up in an emergency room or an urgent care clinic, getting unnecessary tests like ultrasounds or Dopplers.”

— Dr. John Cooper Orthopedic Surgeon at New York-Presbyterian Hospital in Manhattan

Will your arthroplasty patients remain compliant with their physician’s post-surgical protocols?When it comes to surgical technique, you feel confident—but after discharge, many aspects of recovery are outside of your control

Early ambulation is paramount to recovery...

...but edema can get in the way.

Reduces length of stay2

Cuts total hospitalization costs2

Leads to better restoration of range of motion2

Will pain and edema inhibit ambulation?

Will the peak swelling period at 1 week post-op discourage your patients and lead to unnecessary ER visits?

Will complications or readmissions drain your reimbursement?

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With recovery depending so much on your patients, is there a better way to help them remain compliant with rehabilitation?

• Delivers continuous -125mmHg to the incision site

• Helps hold incision edges together3

• Removes fluid and infectious materials4

• Creates a barrier to external contaminants5

• Reduces edema6

Passive Therapy

PREVENA™ Therapy

Introducing the PREVENA RESTOR™ Incision Management System with ARTHRO•FORM™ Dressing

Less edema may help facilitate ambulation

14 days of negative pressure therapy14

Promotes the wound healing cascade and puts patients on the path to recovery by enabling a more active rehab

Manages the incision and surrounding soft tissue to help reduce edema

(Therapy should be continuous for a maximum of 7 days per dressing)

75%fewer overall wound complications (2/30) vs. antimicrobial dressings (29/108)7

fewer reoperations (2/79) vs. antimicrobial dressings (10/80)8

Built on the same proven technology as the original PREVENA™ Therapy*

Brings more confidence and peace of mind by providing negative pressure therapy during the critical post-op window

SCIENTIFICALLY PROVEN BENEFITS OF THE ORIGINAL PREVENA™ THERAPY*

Studies have shown PREVENA™ Therapy* can result in:

• 85% reduction in edema (1/196) vs. standard surgical dressings (13/400)9

• Increased tissue perfusion10*

• Improvements in wound healing10*

Manages the incision and surrounding soft tissue with negative pressure

• 86% fewer infections (1/329) when compared with standard surgical dressings (8/384)11

Creates a barrier to external contaminants while actively removing fluid and infectious materials

• Up to 68% greater closure than competitors12†

• Reduces lateral tension on the epidermis3

• Holds incision edges together3

Mechanically stabilizes the incision site to help facilitate closure

80%

*In an animal model compared to gauze, as measured by VEGF and Factor VIII expression †In a comparative bench study under controlled conditions

The data referenced in this brochure was derived from studies using the KCI family of negative pressure technology, but not specifically the PREVENA RESTOR™ System

PREVENA™ Therapy* reduces the total cost of care

In addition to saving money on complications, an optimized healing experience can lead to:

The original PREVENA™ Therapy* has been shown to cut overall costs by an average of

per patient13

$6,000

Designed to reduce costly wound complications that may erode your bundle

2x–2.5x increase in spending on TKA cases with SSI and post-acute revisions14

Mean episode spending

Average 90-day cost with SSI

Additional cost (cost-avoidance opportunity)

Medicare TKA $25,545 $53,775 $28,230

Medicare revision $38,167 $56,097 $17,930

Commercial TKA $24,274 $58,692 $34,418

Commercial revision $33,539 $49,513 $15,974

Increased practice cost efficiency

Improved patient quality of life15

A simple, efficient process for you and your patient

Streamline post-op incision management to deliver a positive experience

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• Lightweight, portable, and easy to use

• Provides 14 days of therapy, with minimal dressing changes (dressing change required at 7 days)

• Helps patients get back on their feet

• Helps reduce edema that may inhibit recovery protocol compliance

• Limited maintenance and upkeep required

• Simple to assemble and apply

• Reduces downtime spent teaching patients how to care for their incision

• Less worry about rehab compliance

• Relieves the pressure on your resources

• Easy to remove and submit for recycling

Surgeon Patient

Simplifies recovery for both the patient and surgeon

Product specs

PREVENA RESTOR ARTHRO•FORM™ Dressing • Available in 33cm x 30cm and 46cm x 30cm• Dressing change required after 7 days

PREVENA PLUS™ Connector Used to connect the ARTHRO•FORM™ Dressing tubing to the PREVENA PLUS™ 125 Therapy Unit

PREVENA PLUS™ 125 Therapy Unit • Rechargeable therapy unit lasts for up to 14 days

and automatically shuts off at the end of therapy

• The PREVENA PLUS™ Therapy Unit Canister easily attaches to the therapy unit to store exudate

Product SKUs

The PREVENA RESTOR™ Incision Management System contains the following single-use, disposable components:

The PREVENA RESTOR™ Incision Management System is also compatible with the PREVENA PLUS™ 125 Therapy Unit (7 day)

PREVENA PLUS™ 125 Therapy Unit Components

PREVENA PLUS™ 125 Therapy Unit

(14 day)

PREVENA PLUS™ Therapy Unit Carry Case

PREVENA™ Patch Strips

PREVENA PLUS™ Connector

PREVENA PLUS™ 125 Therapy Unit

Power Supply with Power Cord

SKU Description UOM

PRE5001 PREVENA RESTOR ARTHRO•FORM™ System Kit - 33cm x 30cm 1

PRE5101 PREVENA RESTOR ARTHRO•FORM™ System Kit - 46cm x 30cm 1

PRE5055 PREVENA RESTOR ARTHRO•FORM™ Dressing - 33cm x 30cm 5

PRE5155 PREVENA RESTOR ARTHRO•FORM™ Dressing - 46cm x 30cm 5

PREVENA PLUS™ Therapy Unit Canister

(150ml)

Applying the PREVENA RESTOR™ Incision Management System is quick and easy

Preparing the site

After surgery, cleanse the application site with sterile gauze and sterile wound cleaning solution and pat dry with sterile gauze

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1Prior to surgery, shave or clip the surgical area where the dressing will be applied, following institutional policy

2Gather all items needed for application:• Sterile wound cleaning solution,

e.g., water, saline or alcohol

• Sterile gauze or other material to clean the application site

• All components of the PREVENA RESTOR™ Incision Management System (dressing and therapy unit)

Applying the dressing

Measure the incision and choose the appropriate PREVENA RESTOR™ Incision Management Kit.

Gently peel back one release liner on the back of the dressing to expose the adhesive.

1 2

Center and apply the dressing over the closed wound or incision. Remove the remaining release liner by grasping the tab and gently pulling.

Firmly press around the dressing to ensure a good seal where the adhesive contacts the skin. Then remove the top stabilization layers.

3 4

Simply PEEL & PLACE

Connecting the dressing to a PREVENA PLUS™ 125 Therapy Unit (14 day)*

Insert the canister into the therapy unit.

Therapy unit

Lockingtab

Connect the PREVENA PLUS™ Connector to the canister by plugging the connector onto the tubing ports on the side of the canister.

1 2

Connect the dressing tubing to the PREVENA PLUS™ Connector by pushing and twisting the connectors to lock. Ensure that the clamp on the canister tubing is open.

Begin therapy by pressing and holding the On/Off button for three seconds. The green lights on the front of the unit will illuminate, indicating that therapy is active.

3 4

*Also compatible with the PREVENA PLUS™ 125 Therapy Unit (7 day)

How confident are you when you discharge patients?

How are you ensuring that the incision stays closed and protected?

How are you managing the incision site and the soft tissue surrounding the incision?

Can you tell which patients will comply with rehab?

How big of a problem is post-op edema?

What steps can you take to improve cost efficiency?

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See how you can discharge with confidence with the PREVENA RESTOR™ System

The data referenced in this brochure was derived from studies using the KCI family of negative pressure technology, but not specifically the PREVENA RESTOR™ System.

Copyright 2019 KCI Licensing, Inc. All rights reserved. Unless otherwise noted, all trademarks designated herein are proprietary to KCI Licensing, Inc., Systagenix Wound Management, Ltd., or Crawford Healthcare, Ltd. LIT#29-A-388 • PRA-PM-US-01046 (05/19)

References: 1. Bernatz JT, Tueting JL, Anderson PA. Thirty-day readmission rates in orthopedics: a systematic review and meta-analysis. PLoS One. April 17, 2015. doi:10.1371/journal.pone.0123593. 2. Pua YH, Ong PH. Association of early ambulation with length of stay and costs in total knee arthroplasty: retrospective cohort study. Am J Phys Med Rehabil. 2014;93(11):962-970. doi:10.1097/PHM.0000000000000116. 3. Wilkes RP, Kilpadi DV, Zhao Y, et al. Closed Incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012;19(1):67-75. 4. Kilpadi DV, Cunningham MR. Evaluation of closed incision management with negative pressure wound therapy (CIM): hematoma/seroma and involvement of the lymphatic system. Wound Repair Regen. 2011;19(5):588-596. doi:10.1111/j.1524-475X.2011.00714.x. 5. Payne J. Evaluation of the resistance of the Prevena incision dressing top film to viral penetration. San Antonio, TX: Kinetic Concepts, Inc.; June 19, 2009. Report No.: 0000021109. 6. Glaser DA, Farnsworth CL, Varley ES, et al. Negative pressure therapy for closed spine incisions: a pilot study. Wounds. 2012;24(11):308-316. 7. Cooper HJ, Bas MA. Closed-incision negative-pressure therapy versus antimicrobial dressings after revision hip and knee surgery: a comparative study. J Arthroplasty. 2016;31(5):1047-1052. doi:https://doi.org/10.1016/j.arth.2015.11.010. 8. Newman JM, Siqueira MBP, Klika AK, et al. Use of closed incisional negative pressure wound therapy after revision total hip and knee arthroplasty in patients at high risk for infection: a prospective, randomized clinical trial. J Arthroplasty. November 17, 2018. pii:S0883-5403(18)31144-6. doi:10.1016/j.arth.2018.11.017. 9. Redfern RE, Cameron-Ruetz C, O’Drobinak SK, et al. Closed incision negative pressure therapy effects on postoperative infection and surgical site complication after total hip and knee arthroplasty. J Arthroplasty. 2017;32:3333-3339. 10. Shah A, Sumpio BJ, Tsay C, et al., Incisional negative pressure wound therapy augments perfusion and improves wound healing in a swine model pilot study. Ann Plast Surg. 2019; 82(4S):S222-S227 11. Law A, Griffin L. Comparison of quality metrics for patients undergoing total hip or knee arthroplasty with and without closed incision negative pressure therapy. Poster symposium on advanced wound care, Wound Healing Society; April 2017; San Diego, CA. 12. Kilpadi DV, Olivie M. Impact of 2 negative pressure incisional management systems on simulated incisions in a tissue proxy at 2 time points. AWC/WHS. Atlanta, GA. 2016. 13. Kwon J, Staley C, McCullough M, et al. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018;68(6):1744-1752. 14. Centers for Medicare & Medicaid Services. Standard Analytical Files for 90-day episodes initiated January 1, 2014–September 30, 2015. CMS.gov.https://www.cms.gov. Accessed January 12, 2019. 15. Lee AJ, Sheppard CE, Kent WDT, et al. Safety and efficacy of prophylactic negative pressurewound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study. Interact CardioVasc Thorac Surg. 2016. doi:10.1093/icvts/ivw400.

To learn more, contact your local KCI representative.

The PREVENA RESTOR™ Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

*PREVENA™ 125 and PREVENA PLUS™ 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA™

125 and PREVENA™ PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma; and in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.

The effectiveness of PREVENA™ Therapy in reducing the incidence of SSIs and seroma in all surgical procedures and populations has not been demonstrated. See full indications for use and limitations at myKCI.com

NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for the PREVENA RESTOR™ Incision Management System.Please consult a physician and product instructions for use prior to application. Rx only.