Overview

The Prospera PRO series of negative pressure wound therapy systems is designed to advance the art and science of NPWT for clinicians and patients. The PRO-I^TM and PRO-II^TM are engineered specifically for use with NPWT and provide ease of use and flexibility for clinicians, cost effective outcomes and perhaps most importantly it is designed to put the needs of patients first.

Patient comfort and quality of life increases compliance

• Virtually silent operation means patient stress levels due to noise is significantly reduced and patients are able to sleep through the night.
• VPT® and lower CPT negative pressure options decrease patient pain during therapy.
• Our dressing protocol utilizing moist antimicrobial gauze will not adhere to the wound and substantially decreases the incidence of painful dressing changes
• Our multiple alarm and safety feature protect the patient but if alarms are causing patient distress the pump can be turned off for up to 48 hours depending on the amount of exudate.

Customize Pressure Settings to Maximize Outcomes.

Best practices in wound care call for customized treatment plans for each wound and patient. NPWT should be equally customizable. Wound etiology, patient pain thresholds and recent research regarding the potential benefits of lower negative pressure settings for different types of tissue can help strive for maximize outcomes. With the PRO series clinicians can:
Opt for Continuous Pressure Therapy (CPT) and set pressure levels as needed or opt for Variable Pressure Therapy (VPT®) which allows clinicians to choose pressure and duration levels for high and low settings.

Over the span of a century, researchers and clinicians have described improved wound healing with adjunctive NPWT. In practice, the benefits and goals of removing excessive exudate from purulent wounds through vacuum assisted drainage have grown to include:

• Reduction of painful dressing changes
• Increased blood flow
• Maintenance of a moist wound environment
• Removal of third-space fluids and debris
• Establishment of fluid balance
• Reduction of edema
• Increased growth factors
• Positive effects on leukocytes and fibroblasts
• Removal of slough
• Improved wound stability
• Prevention of maceration

Recent research and expanding clinical experience aim to more fully explain the underlying mechanisms by which NPWT confers its benefits, and to optimize treatment protocols.

In general, there is increased dialogue among wound care specialists about:

The use of lower negative pressure settings in general than traditionally applied

The use of different pressure recommendations for different types of tissue

The potential benefits of using variable pressure therapy and intermittent pressure therapy protocols versus continuous therapy

Prospera Pro I^TM, Pro II^TM and Pro III^TMare reimbursable under most third party payer plans.



If you have questions regarding coding or billing, you should contact
your payor.



Below are the HCPCS codes for the Prospera® Negative Pressure Wound Therapy System:

PRODUCT	CODE	DESCRIPTION
Prospera® PRO-ITM	E2402	Negative pressure wound therapy electrical pump, stationary or portable
Prospera® Dressing Change Kit	A6550	Dressing set for negative pressure wound therapy electrical pump, stationary or portable, each
Prospera® Canister	A7000	Canister, disposable, used with suction pump, each

Case Studies

Early Experience with Prospera PRO-I^TM

Negative Pressure Wound Therapy



Thomas Eberlein, MD, Helmut Fendler RN

Gesundheits Manager Health and Wound Management, Nuremberg,

Germany, February 2008



NPWT HISTORY



The efficacy of Negative Pressure Wound Therapy ("NPWT") to promote wound healing has been well documented
in literature for nearly 100 years. Since its inception in 1908, there has been continuous development
through scientific means to advance the NPWT technology. In early 50's the 1st of several patents was
issued for the purpose of NPWT and wound drainage. These patents established the fundamental basis and
prior art for the NPWT concept. Furthermore, the broad use of various types of dressing materials such
as foam, gauze, plastic and sponge dressings with NPWT was established. During the past 25 years, other
scientists and clinicians have modified and improved both the technique and the selection of dressing
materials. Several US patents have been issued during this period all following the basic principals and
claims of these earlier patents and published clinical studies.



The Prospera® PRO-I^TM pump for NPWT features further advancements based on lower continuous vacuum therapy
and customizable intermittent pressure therapy. The concept of lower pressure settings for continuous
therapy and variable pressure therapy (VPT®) providing gentler pressure settings encourages wound closure
while simultaneously providing patient comfort and cost effective therapy.

NPWT PERSONAL EXPERIENCE

The use of NPWT as an adjunctive therapy was initially started in our wound care practice in 1995. Earlier
NPWT therapy was discontinued due to patient discomfort during therapy, excruciating pain during dressing
changes and the high cost of treatment.



Over the last 12 months, Prospera® PRO-I^TM NPWT system has been utilized in our practice to treat various types of acute and chronic wounds with
great success providing ease of use, patient comfort, excellent wound closure, and overall cost effective outcomes.
The use of VPT® has been extremely effective in providing patient comfort.



Although further evaluation of the PRO-I^TM is warranted, based on our experience with different NPWT systems
currently available in the market place, PRO-I^TM provides a more complete therapy system due to its unique design
and customizable flexible settings.

What are the indications for Negative Pressure Wound Therapy?

The Prospera PRO Negative Pressure Wound Therapy pumps are indicated for patients who would benefit from
a suction device, particularly as the device may promote wound healing.

Is NPWT recommended for use all the way to healing?

NPWT is an interim adjunctive therapy for wounds of significant tissue deficit in which granulation and
contraction are necessary for timely progress. Prospera does not promote the use of NPWT until closure.
The provider should have a goal of therapy in mind and know when to implement NPWT and when to evaluate
and discontinue.

Are there any Contraindications for using the PRO-I or PRO-II?

When used for wound healing, the PRO-I and PRO-II are contraindicated in the presence of:

• Necrotic Tissue
• Unexplored or non-enteric fistulas
• Untreated Osteomyelitis
• Wounds containing malignant tissue
• Exposed arteries, veins, or organs

Precautions should be taken in the presence of:

• Anticoagulation or active bleeding
• Difficult wound hemostasis
• Close proximity of blood vessels, organs, muscle and fascia requiring adequate protection
• Irradiated vessels ands tissue
• Bony fragments
• Untreated malnutrition
• Non-compliance

What is VPT®

In contrast to intermittent therapy which indicates pressure is on and then off, Prospera advocates using a
higher pressure of 60-80 mmHg and a lower pressure of 30-40 mmHg. Pressures increase and decrease in small
increments creating a 'gentle massage' of the wound tissue. This concept of Variable Pressure Therapy
establishes a continuous environment of negative pressure using alternating prescribed pressures. Using
variable pressures allows negative pressure wound therapy to draw blood cells to the wound and during the
lower pressure cycle allow dispersion of the newly arrived cells without losing the negative pressure environment. How do I decide whether to use continuous pressure or VPT®

The amount of exudate output should be your guide to Continuous or VPT. Heavily exuding wounds or high output
fistulas that collect enough fluid requiring canister changes with each dressing change should be controlled
using Continuous NPWT. Routine canister changes are recommended once a week. The decision to use Continuous
or VPT is up to the provider. Wounds that 'stall' can show improvement when changed from Continuous to VPT.
Any wound can benefit from VPT if the exudate or effluent is controlled. Fistula closure can be promoted
with lower VPT settings as the effluent begins to decrease. Recent and ongoing research is focusing on
Variable Pressure Therapy at lower settings.

Are there guidelines or recommendations for how to choose appropriate pressure settings?

Yes..

Why do you use antimicrobial gauze as your cover dressing?


NPWT can be beneficial to wounds by controlling and removing exudate which in turn reduces the environment
for bacterial growth. Unlike the current guideline, any wound (using moist antimicrobial gauze) with a planned or unplanned
interruption in NPWT of over 4 hours does not require a dressing change. The use of AMD gauze, which contains
polyhexamethylene biguanide (PHMB), offers a 48 hour microbe controlled environment.

Will I give up efficacy or speed to healing by using simple antimicrobial gauze?

The concept of NPWT was first documented in 1908. Although the concept has been around for 100 years the
exact science was not well understood. The contact layer next to the wound has been a subject of great debate.
Recent studies with gauze has shown impressive wound healing. Comparative research has not be done to date and
it is unforeseen a randomized double blind controlled placebo study will be done. It would be very difficult
to blind the products for unbiased use. NPWT research continues to be done emphasizing the concept of NPWT
itself and not the contact layer.

If my patient is temporarily off the pump do I have to change the dressing within
a given time frame?


No. Moist antimicrobial gauze offers two unique properties: the hydrophilic nature of gauze meaning it has an absorptive property
and the antimicrobial protection provided by PHMB. If NPWT was interrupted, these two characteristics would allow
the wound to remain in a 'safe' environment as the dressing continues to control exudate and microbes.

How do I choose the appropriate drain?

The versatility of the drains provides clinicians the opportunity to customize their wound dressings. As a rule of
thumb; the bigger the wound, the bigger the drain.

What kind of safety features do you have on the PRO-I and PRO-II?


Advanced alarms include: open system, closed system, battery low, battery empty, battery hot, battery fault,
internal error, restart pump. If alarms sound at night or when the patient is alone the pump can be turned off
until a clinician is available to address alarm issue. Our dressing system will provide antimicrobial protection
for up to 48 hours depending on volume of exudate.

Is your product reimbursable?

Yes. All Negative Pressure Wound Therapy devices are billed under the same HCPCS code. Our products are reimbursable
under most third party payer plans. We also have Medicare HCPCS codes which are available under the reimbursement
tab at the top of the page.

How is your pump different from other pumps on the market?


Prospera pumps are lightweight, provide virtually silent operation, fully customizable pressure options(VPT and CPT)
and settings and multiple alarms for patient safety.

My patients complain of excruciating pain during dressing changes. Do you
have any tips on how to make this process less painful?

Patients have reported to us that our dressing protocol is comfortable both during use and particularly during
dressing changes. Moist antimicrobial gauze will not adhere to the wound and will not allow in-growth of the granulation tissue
into the cotton fiber weave. Dressings are easier to release and remove from the granulation (or other structure).
If adherence of the cotton layer to the wound bed should occur, simply hydrating the gauze will promote its release.

How about pain during use?


Prospera® recommended lower pressure settings provide added patient comfort. Our customizable VPT® settings provide a
gentle massage effect at the wound bed. Many patients report not even feeling pressure changes. The fully customizable
features of the pump allow clinicians to adjust settings to accommodate differing patient pain thresholds.

Are the PRO-I and PRO-II available in my area?

Prospera PRO-I and PRO-II pumps are available through our national distributor: RecoverCare. We also have several
regional distributors who may provide service in your area. Please contact us for specific information.

Can I use the PRO-I and PRO-II devices on fistulas?


Most definitely! The drain variety allows the end-user to select the appropriate drain size for the amount of
effluent and debris. Large lumen drains promote easy effluent and debris removal reducing the risk of clogged
dressings.