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PREVENA™ Incision Management System


PREVENA PLUS™ Incision Management System
PREVENA PLUS™ Incision Management System
PREVENA™ PEEL & PLACE™ System – 13cm
PREVENA™ PEEL & PLACE™ System – 13cm
PREVENA™ PEEL & PLACE™ System – 20cm
PREVENA™ PEEL & PLACE™ System – 20cm

The First Disposable Powered Negative Pressure System Designed Specifically for the Management of Closed Surgical Incisions.

The PREVENA™ Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.
 
PREVENA™ 125 Therapy Unit Features:
  • Single-patient use
  • Lightweight and portable
  • One-touch operation for continuous -125mmHg
  • Replaceable canister
  • Audible and visual alarms
  • Optional connector for use with certain V.A.C.® Negative Pressure Wound Therapy Units

 

 

Overview

Over 60 Publications Supporting Negative Pressure Incision Management

Easy to Use

 
  • Off-the-shelf disposable components
  • Easy to use PEEL & PLACE™ Dressings
  • CUSTOMIZABLE™ Dressing
 

Patient Friendly

 
  • Skin-friendly interface layer
  • Barrier to external contaminants
  • Patient can shower with dressing in place
 

How it Works

  • About
  • Specifications
  • Materials For Download

About

Surgical Incision Protection
 

PREVENA™ Therapy helps manage and protect surgical incisions utilizing unique PEEL & PLACE™ or CUSTOMIZABLE™ Dressings by:
 
  • Helping hold incision edges together
  • Removing fluids and infectious materials
  • Acting as a barrier to external contamination
  • Delivering continuous negative pressure (-125mmHg) for up to 7 days
 
PREVENA™ MOA Video

Specifications

PREVENA™ PEEL & PLACE™ System
 
PREVENA™ 125 Therapy Unit
  • Continuous NPWT at -125 mmHg
  • Disposable, single patient use
  • 3 AA batteries pre-installed
  • 192-hour (8-day) life cycle of the therapy unit
  • Weight: Approx 195 grams
  • Dimensions : Approx 13.6 x 7.5 x 3 cm
 
PREVENA™ Therapy Dressings
  • Contains a skin-friendly wicking interface layer that includes 0.019% ionic silver and polyurethane foam
  • Silver (0.019%) in the interface layer is not intended to treat infection, but to reduce bacterial colonization in the fabric
 
PREVENA™ PEEL & PLACE™ Dressing - 20cm
  • Polyurethane foam in polyurethane film: 25.4 x 6.4 x 1.8 cm
  • Polyurethane film: 35.6 x 20.3 cm
  • Connecting tube (integrated with dressing) Dressing tube length: 112 cm
  • Pressure indicator: Integrated
  • Appropriate incision length Maximum: 20cm (8 inches)
 
PREVENA™ PEEL & PLACE™ Dressing – 13 cm
  • Designed for linear incisions up to 13cm in legth
  • Polyurethane foam in polyurethane film: 15.2 x 6.4 x 1.8 cm
  • Polyurethane film: 22.8 x 13.3 cm
  • Connecting tube (integrated with dressing) Dressing tube length: 112 cm
  • Pressure indicator: Integrated
  • Appropriate incision length: Maximum 13 cm (5 inches)
 
PREVENA™ Therapy 45ml Canister
  • 45cc/ml canister with connecting tubing single use, sterile, disposable
  • Canister: 7.2 x 6.9 x 3 cm
  • Canister tube length: 20.2 cm

Environmental Conditions
  • Storage temperature range: -4°F (-20°C) to 140°F (60°C)
  • Operating temperature range: 41°F (5°C) to 104°F (40°C)
  • Relative humidity range: 15-95%, non-condensing
 
Electrical Specifications
  • Battery powered using primary (non-rechargeable) 3 AA Lithium-ion batteries
  • IEC Classification: Medical Equipment
  • Electrical Safety : Internally powered
  • MC: Class B for hospital use
  • Equipment not suitable for use in presence of flammable anesthetic mixture with air, oxygen or nitrous oxide
  • Type BF Applied Part according to IEC 60601-1: 2005 (3rd Ed)
  • IP24 Protection against solid objects greater than 12.5 mm and against liquid water sprays for short periods of time
  • Manufactured with natural rubber Latex: No
  • Contains DEHP (Di(2-ethylhexyl)phthalate) : No
  • Contains Mercury: No
  • Contains Haz Mat: No
  • Contains Thimerosal: No
  • Radiopaque: No
 
PREVENA PLUS™ System
 
PREVENA PLUS ™ 125 Therapy Unit
  • Continuous NPWT at 125 mmHg
  • Disposable, single patient use
  • Weight with empty canister: 0.7 lbs (0.32 kg)
  • Dimensions : Approx 16 x 9 x 3 cm

PREVENA PLUS™ Dressing
  • Contains a skin-friendly wicking interface layer that includes 0.019% ionic silver and polyurethane foam
  • Silver (0.019%) in the interface layer is not intended to treat infection, but to reduce bacterial colonization in the fabric 
 
PREVENA PLUS™ CUSTOMIZABLE™ Dressing with SENSAT.R.A.C.™ Technology
  • Polyurethane foam with hydrocolloid strips: 90 x 9.8 x 1.8 cm
  • Hydrocolloid strips (2): 2 x 24 cm each
  • SENSAT.R.A.C.™ Pad and Tubing: separate part
  • SENSAT.R.A.C.™ tubing length: 91 cm
  • Appropriate incision length: recommended 90 cm (34.5 inches) or less

PREVENA PLUS™ 150cc Canister
  • 150cc/ml canister with connecting tubing single use, sterile, disposable
  • Canister: 15.5 x 9 x 2.5 cm
  • PREVENA PLUS™ Connector tube length: 45 cm
 
Environmental Conditions
  • Storage temperature range: 0°F (-18°C) to 140°F (60°C)
  • Operating temperature range: 41°F (5°C) to 104°F (40°C)
  • Altitude range for optimum performance : -1253 to 9878 feet (-381.9 m to 3010 m)
  • Relative humidity range: 15-93%, non-condensing
 
Electrical Specifications
  • Battery powered using a rechargeable Lithium-ion battery pack with AC Mains disconnection
  • IEC Classification: Medical Equipment
  • Electrical Safety: Class II
  • EMC: The PREVENA PLUS™ 125 Therapy unit conforms to the intent of the 2004/108/EC EMC Directive; however, all medical equipment may produce electromagnetic interference or be susceptible to electromagnetic interference.
  • Equipment not suitable for use in presence of flammable anesthetic mixture with air, oxygen or nitrous oxide
  • Type BF Applied Part according to IEC 60601-1: 2005 (3rd Ed)
  • IP22 Protection against solid objects greater than 12.5mm and against liquid water falling for short periods of tim
  • Manufactured with natural rubber Latex: No
  • Contains DEHP (Di(2-ethylhexyl)phthalate): Yes, SensaT.R.A.C. tubing
  • Contains Mercury: No
  • Contains Haz Mat: No
  • Contains Thimerosal: No
  • Radiopaque: No
 

Indications & Applications

Indications & Applications

  • Indications
  • Applications

Indications for Use

Before use, physicians should review complete risk information and essential prescribing information which can be found in the Product Instructions for Use .
 
The PREVENA™ Incision Management System is intended to manage the environment for 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. 
 
For maximum benefit, the PREVENA™ Incision Management System should be applied immediately post surgery to clean surgically closed wounds. It is to be continuously applied for a minimum of 2 days up to a maximum of 7 days. It can transition home with the patient; however, all PREVENA™ Dressing changes should be performed under direct medical supervision.
 

Instructions for Use

Clinical Solutions for

Evidence & Outcomes

PREVENA™ Therapy is supported by over 60 clinical publications. Some of them are listed below.

Clinical Evidence

Additional summary of evidence and outcomes.

Evidence & Outcomes

Product Evidence and Outcomes

Title Study Type Date Authors