Negative Pressure Wound Therapy

Devon Medical Products • King of Prussia, PA

Founded: 2005 • www.devonmedicalproducts.com
info@devonmedicalproducts.com • (866) 446-0092

1) How many different NPWT products does your company produce? We currently produce one NPWT product, the extriCARE™ 2400 Negative Pressure Wound Therapy Device.

2) What is your most popular NPWT product? The extriCARE 2400 NPWT Device.

3) What is the suction pressure of your machine or the range of pressure the machine achieves? Between 60 and 140 mmHg in intervals of 20 mmHg.

4) Is the pressure pre-set? It has a factory default of 120 mmHg.

5) Can this be changed? Yes, it can be set at 60, 80, 100, 120, or 140 mmHg.

6) Is there an intermittent feature? Yes.

7) Is there a cutoff that stops suction if the canister is full? Yes.

8) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? No.

9) How long does the battery last? 24 hours in “continuous” mode.

10) How much does the machine weigh? 8.6 ounces.

11) What is the interface with the wound? PU film bandages.

12) How often do you recommend changing the dressing? Every 2-3 days.

13) Can you “Y” wounds together? If so, how many? Yes, typically we don’t recommend any more than 2 sites being wound together. Note: The pressure burden with 2 wound sites Y-connected together will be heavier than 1 site alone. This means the intended treatment pressure at each of the Y-connected wound sites will be much lower than the screen display pressure.

14) How do you handle undermining? The undermining wound should be packed using material such as gauze before applying the extriCARE 2400 NPWT Device.

15) How often do you handle fistulas? The extriCARE 2400 NPWT Device is contraindicated for non-enteric and unexplored fistulas. However, enteric fistulas can be treated using the system with special attention from the attending clinicians.

16) How do you handle exposed tendon or bone? Precautionary measures should be taken if any tendon or bones are exposed. Additionally, sharp bone edges require special attention by being covered and smoothed wherever possible.

17) Do you have any special recommendations for high bioburden or infection? High bioburden or infection should be treated with antibiotics or equivalent measures before initiating the NPWT therapy. Infected wounds treated using the extriCARE 2400 NPWT Device should be monitored closely, and bandages should be changed more frequently. Additionally, to reduce the risk of transmission of infectious agents, universal precautions should be taken when handling or working with therapeutic parts or equipment.

18) How is your device billed? (Is the machine rented? How are supplies obtained?) The extriCARE 2400 NPWT Device is sold directly to the facility or DME. Inventory is held in King of Prussia, PA.

Kinetic Concepts Inc. (KCI) • San Antonio, Texas

Founded: 1976 • www.kci1.com
media@kci1.com • (800) 275-4524

1) How many different NPWT products does your company produce? KCI manufactures and sells six NPWT products: ActiV.A.C.® Therapy System, InfoV.A.C.® Therapy System, V.A.C. Instill® Wound Therapy, V.A.C.® Freedom Therapy System, V.A.C.Via™ Therapy System, and, most recently, V.A.C.Ulta™ Therapy System. Other KCI devices within its Negative Pressure Technology portfolio include the Prevena™ Incision Management System and the ABThera™ Open Abdomen Negative Pressure Therapy System. For a list of published clinical evidence for our products, visit www.kci1.com/kci1/clinicalevidence.

2) What is your most popular NPWT product? The ActiV.A.C. Therapy System.

3) What is the suction pressure of your machine or the range of pressure the machine achieves? The pressure provided by the ActiV.A.C. Therapy System is preset to -125 mmHg. This default setting is within the V.A.C. Therapy Clinical Guidelines’ recommended range for most wounds. The user-selectable negative pressure range is between -25 and -200 mmHg, with the pressure-setting selection being left to physician discretion.

4) Is the pressure pre-set? The pressure provided by the ActiV.A.C. Therapy System is preset to -125 mmHg and continuous therapy.

5) Can this be changed? Yes, the level of therapeutic negative pressure for all KCI NPWT units can be changed by using the control panel on the therapy unit. Settings are adjustable based on individual patient clinical needs and circumstances.

6) Is there an intermittent feature? Yes, all KCI NPWT units, including the ActiV.A.C. Therapy System, offer continuous and intermittent negative pressure therapy applications.

7) Is there a cutoff that stops suction if the canister is full? All of our NPWT units contain electronic sensors that stop the pump when the canister is full.

8) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? No, however, there are safety features that mitigate retrograde flow toward the patient. Our proprietary SensaT.R.A.C.™ Tubing used in conjunction with V.A.C. Therapy has clamps at both the patient and canister side to prevent this fluid transfer. Additionally, canisters are available with a gel pack that helps to solidify wound exudate.

9) How long does the battery last? The ActiV.A.C. Therapy System’s battery lasts for 14 hours, on average, when fully charged.

10) How much does the machine weigh? (How portable is it?) The ActiV.A.C. Therapy System is fully portable and only weighs 2.4 lbs when the 300 ml canister is empty. The recently launched V.A.C.Via Therapy System is specifically designed for mobility and weighs only 0.7 lbs with a 250 ml canister.

11) What is the interface with the wound? KCI offers a variety of wound dressings: V.A.C. GranuFoam™ Dressing, V.A.C. GranuFoam Silver® Dressing, V.A.C. WhiteFoam Dressing, V.A.C. Simplace™ Dressing, and V.A.C. GranuFoam Bridge Dressing. Additional V.A.C. GranuFoam Specialty Dressings are also available.

  The V.A.C. GranuFoam Dressing is placed directly at the wound site to facilitate negative pressure application. The unique pore structure of V.A.C. GranuFoam Dressings helps promote healing and tissue granulation. Each tiny pore is intended to deliver mechanisms critical to wound healing. The V.A.C. GranuFoam Dressing adapts to the contours of deep and irregularly shaped wounds, helps provide uniform distribution of negative pressure at the wound site, helps facilitate exudate and removal of infectious material through a hydrophobic pore structure, compresses to less than half its size under negative pressure to help draw wound edges together, and induces macrostrain and microstrain.

12) How often do you recommend changing the dressing? Current device labeling recommends the following: a) Wounds being treated with V.A.C. Therapy should be monitored on a regular basis. b) In a monitored, non-infected wound, V.A.C. Dressings should be changed every 48-72 hours, but no fewer than 3 times per week, with frequency adjusted by the clinician as appropriate. c) Infected wounds must be monitored often and very closely. For these wounds, the dressing change intervals should be based on a continuing evaluation of wound condition and the patient’s clinical presentation, rather than a fixed schedule. d) Dressings may need to be changed more often than 48-72 hours.

13) Can you “Y” wounds together? If so, how many? Yes, the ActiV.A.C. Therapy System can be used to “Y” 2 wounds together if they are of the same etiology. By applying a Y-connector to the canister tubing, 1 V.A.C. Therapy unit may be used to simultaneously treat multiple wounds on the same patient.

14) How do you handle undermining? KCI V.A.C. WhiteFoam Dressing may be placed in undermined areas with good foam-to-tissue contact. When using the V.A.C. WhiteFoam Dressing, the minimum pressure setting is -125 mmHg.

15) How often do you handle fistulas? V.A.C. Therapy is contraindicated for use with non-enteric and unexplored fistulas. If considering the use of V.A.C. Therapy involving enteric fistula, it’s recommended to seek support from an expert clinician. V.A.C. Therapy is not recommended or designed for fistula effluent management or containment, but as an aid to wound healing in and around the fistula.

16) How do you handle exposed tendon or bone? Tendons, ligaments, and nerves should be protected to avoid direct contact with V.A.C. Dressings and can be covered with natural tissue or meshed, non-adherent porous material or bioengineered tissue to help minimize risk of desiccation or injury. Bone may be protected with a single layer of a non-adherent interface.

17) Do you have any special recommendations for high bioburden or infection? V.A.C. Therapy is contraindicated for untreated osteomyelitis. If clinicians decide to use V.A.C. Therapy for other infected wounds, they must be monitored often and very closely, and dressings may need to be changed more often than 48-72 hours in order to assess the wound and patient condition. The dressing change intervals should be based on a continuing evaluation of wound condition and the patient’s clinical presentation, rather than a fixed schedule.

18) How is your device billed? (Is the machine rented? How are supplies obtained?) The ActiV.A.C. Therapy System and V.A.C. Freedom Therapy Systems are rented and typically billed to the patient’s insurance, depending on eligibility and coverage. Dressings are available for purchase and supplies are replenished, as needed, based on clinical evaluation by healthcare professionals. For proper use of KCI NPWT products, please refer to the V.A.C. Therapy Clinical Guidelines, A Reference Source for Clinicians, and device labeling.

Medela Inc. • McHenry, IL

Founded: 1961
www.medela.com • suction@medela.com • (877) 694-6842

1) How many different NPWT products does your company produce? We offer a complete NPWT portfolio, including pumps, wound care kits, and accessories.

2) What is your most popular NPWT product? Invia Liberty.

3) What is the suction pressure of your machine or the range of pressure the machine achieves? 60 mmHg-200 mmHg.

4) Is the pressure pre-set? Yes.

5) Can this be changed? Yes.

6) Is there an intermittent feature? Yes.

7) Is there a cutoff that stops suction if the canister is full? There’s an initial warning 30 min prior, with auto shutoff.

8) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? Yes.

9) How long does the battery last? Up to 14 hours.

10) How much does the machine weigh? 2.2 lbs.

11) What is the interface with the wound? Wound contact layer, foam, or gauze.

12) How often do you recommend changing the dressing? We recommend 2-3 times weekly.

13) Can you “Y” wounds together? If so, how many? Yes, at least 4 or at clinician discretion.

14) How do you handle undermining? 15F Channel drain is specifically designed for this purpose.

15) How often do you handle fistulas? Enteric and explored fistulas may be managed with the 15F Channel drain specifically designed for this purpose.

16) How do you handle exposed tendon or bone? With precaution and covering all fragile structures with wound contact layer.

17) Do you have any special recommendations for high bioburden or infection? Our customary kits contain antimicrobial gauze specifically designed for this purpose.

18) How is your device billed? (Is the machine rented? How are supplies obtained?) The devices may be obtained through rental or purchase. Both devices and kits are reimbursed through Medicare Part B and commercial payers.

Smith & Nephew • St. Petersburg, FL

Founded: 1856 • www.myrenasys.com
www.possiblewithpico.com • (800) 876-1261

1) How many different NPWT products does your company produce? We produce more than 25 NPWT products, including the pocket-sized PICO™ system, a single-use NPWT system; the RENASYS™ GO and RENASYS EZ Plus devices; RENASYS-F Foam and RENASYS-G Gauze Dressing kits; RENASYS-AB Abdominal Dressing Kit; RENASYS High Output Kit; RENASYS Channel Drain Kit; 800 mL, 300 mL, and 250 mL canisters; Transparent Films, Y-connectors; and other NPWT accessories. The RENASYS EZ Plus and RENASYS GO are available with RENASYS Soft Port, which enables NPWT to be delivered directly at the wound site without sacrificing patient comfort or safety and reducing the need for bridging.

2) What is your most popular NPWT product? In the home care market, the RENASYS GO device is our most popular product. It is effective and user-friendly. The pump is lightweight (2.4 lbs), quiet, and can be used with either a 300 mL or 800 mL canister, enhancing mobility for home care and acute care use. The acute care market favors RENASYS EZ Plus for its robust, easy-to-use solution for high-volume output wounds with the flexibility to treat a variety of acute and chronic wounds. Our recently introduced PICO system is also gaining in popularity, due to its canister-free small size and overall simplicity.

3) What is the suction pressure of your machine or the range of pressure that the machine achieves? RENASYS GO: 40 mmHg-200 mmHg; RENASYS EZ PLUS: 40 mmHg-200 mmHg; PICO: operates at continuous negative pressure of nominally 80 mmHg.

4) Is the pressure pre-set? Not on the RENASYS EZ Plus or the RENASYS GO. The pressure is pre-set on the PICO system, and it operates at continuous negative pressure of nominally 80 mmHg.

5) Can it be changed? The pressure setting on the RENASYS devices can be changed. With both pumps, the pressure can be set at different levels. The device resumes at the same level of pressure as was set when it was last turned off or set to “standby.” The pressure cannot be changed on the PICO system.

6) Is there an intermittent feature? The RENASYS devices have an intermittent feature. The PICO system does not.

7) Is there a cutoff that stops suction if the canister is full? The RENASYS canisters are protected by a filter. An audible alarm will sound and a visual light flashes when the canister is full, but the devices do not turn off. The PICO system is canister-free.

8) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? The RENASYS and PICO systems have a filter that prevents fluid from coming back through the tubing toward the patient.

9) How long does the battery last? RENASYS GO: 20 hours; RENASYS EZ Plus: 40 hours. The PICO system runs on 2 AA batteries that can be changed if required but should not be necessary. It is indicated for use up to 7 days, at which time the system is disposable.

10) How much does the machine weigh? (How portable is it?) RENASYS GO is 2.4 lbs and comes with a shoulder strap and carry bag. RENASYS EZ Plus is 7.4 lbs and can be mounted on an IV pole and bed rail attachments. PICO is less than 4.2 oz and is small enough to easily fit in a pocket.

11) What is the interface with the wound? For the RENASYS systems, the wound interfaces with foam or gauze devices. The PICO system employs a revolutionary dressing technology that manages exudate, eliminates the need for canisters, and interfaces with the wound.

12) How often do you recommend changing the dressing? We recommend changing foam dressings every 48 hours and changing AMD gauze dressings every 48-72 hours. The PICO system may be left in place for up to 7 days, depending on the level of exudate.

13) Can you “Y” wounds together? If so, how many? We recommend Y-connecting a maximum of 2 wounds with the RENASYS devices. PICO dressings do not Y-connect.

14) How do you handle undermining? The RENASYS Foam and Gauze kits are both indicated for undermining. We also recommend use of the channel drain kit with moistened AMD gauze or the RENASYS-G Kit for its ability to conform to these types of wounds. The PICO system can be used to handle undermining in wounds with the addition of either a foam or a gauze filler.

15) How do you handle fistulas? We offer the RENASYS High Output Kit, which includes a large 28fr round irrigation aspiration drain. This kit is indicated for explored fistulas.

16) How do you handle exposed tendon or bone? For the RENASYS systems, we offer a non-adherent gauze in our gauze kits and recommend the use of a non-adherent layer to use with the foam interface to protect exposed tendon or bone while it is under NPWT.

17) Do you have any special recommendations for high bioburden or infection? We recommend the use of Smith & Nephew ACTICOAT Flex as a wound contact layer for wounds with a high bioburden or infection. ACTICOAT Flex is compatible for use with NPWT with gauze or foam interface materials. ACTICOAT may also be used with PICO.

18) How is your device billed? (Is the machine rented? How are supplies obtained?) Our RENASYS pumps are rented. Dressing kits, canisters, and other services are supplied through our partners: Universal Hospital Services, which supports acute care and long-term care, and Apria Healthcare, which supports home care. Our partners perform third-party billing, and all biomed operation on the pumps to ensure quality pumps are delivered. The PICO system is available off-the-shelf, direct from Smith & Nephew.

Spiracur Inc. • Sunnyvale, CA

Founded: 2007 • www.spiracur.com
info@spiracur.com • (877) 774-7228

1) What is the name of your featured product? SNaP® Wound Care System.

2) Does your product operate without electricity or batteries? Yes, the SNaP System uses a proprietary spring mechanism to generate consistent, even levels of pressure.

3) Does your product operate silently? Yes, it requires no noisy motors, electronics, or batteries to interfere with daily living.

4) Is your product portable? Yes, it is a pocket-sized device that can be worn discreetly under clothing.

5) How much does your product weigh? 2.2 oz.

6) Does your product include an advanced wound dressing? Yes, it has a proprietary hydrocolloid dressing which may reduce periwound maceration.

7) Does your contact layer have antimicrobial properties? Yes, the SNaP System provides a choice of blue foam or antimicrobial gauze. The gauze contains 0.2% polyhexamethylene biguanide.

8) What levels of negative pressure does your product deliver? The SNaP System is available in 125 mmHg, 100 mmHg, and 75 mmHg pressure settings.

9) Is there a cutoff that stops suction if the canister is full? Yes.

10) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? Yes.

11) Can you “Y” wounds together? If so, how many? Yes, 2.

12) How often do you recommend changing the dressing? The SNaP System requires 2 dressing changes per week.

13) Is your system quicker to apply than a powered NPWT device? Yes, the SNaP System takes about half the time to apply than a powered NPWT device.

14) Have you conducted any clinical studies with your product? Yes, we have completed a 132-patient comparative, randomized-controlled study demonstrating non-inferiority to powered NPWT in wound healing outcomes. In addition, patient survey data found improved quality of life in areas such as overall mobility, social interaction, and sleep.

15) Is your product available off-the-shelf? Yes, the off-the-shelf availability eliminates the rental procurement process.