• Holds incision edges together
• Protects incision site from external infectious sources
• Removes fluids and infectious materials from the surgical site
• Lightweight and portable
• Prevena Peel and Place Dressing available (13cm, 20cm, and 35cm) for linear incisions
• Available in a 3M™ Prevena™ Plus Customizable Incision Management System version for linear and non-linear incisions up to 90cm
• Available in 3M™ Prevena™ Plus Duo Incision Management System version with 2 different configurations (13cm/13cm and 20cm/20cm) which can manage 2 incisions at the same time

The 3M™ Prevena™ Plus 125 Therapy Unit is indicated for use with both the 3M™ Prevena™ Dressings and compatible 3M™ V.A.C.® Dressings.

The 3M™ Prevena™ Plus 125 Therapy Unit when used with the 3M™ Prevena™ Dressings (3M™ Prevena™ Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed 3M™ Prevena™ Dressings for up to seven days, the 3M™ Prevena™ Plus 125 Therapy Unit is 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 device is not intended to treat surgical site infection or seroma.
• Safety and effectiveness in pediatric population (<22 years old) have not been evaluated.
• Safety and effectiveness in Class III (Contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily, and the subject device should only be used on closed surgical incisions.
• The device has not been demonstrated to reduce deep incisional and organ space surgical site infections.
• The device has not been demonstrated to be effective in reducing the incidence of surgical site infection and seroma in all surgical procedures and patient populations; therefore, the device may not be recommended for routine use to reduce the incidence of surgical site infection and seroma.
• Please refer to the 'Summary of Clinical Information' section for the specific surgical procedures and patient populations included in the clinical studies. Surgeons should continue to follow the 'Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection' and the 'American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines' for best practices in preventing surgical site infection.

The 3M™ Prevena™ Plus 125 Therapy Unit, when used with compatible 3M™ V.A.C.® Dressings on open wounds (3M™ Prevena™ Negative Pressure Wound Therapy System), is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

Prevena 125 Therapy Unit US

PREVENA™ 125 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 postoperative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
Limitations:
• The device is not intended to treat surgical site infection or seroma.
• Safety and effectiveness in pediatric population (<22 years old) have not been evaluated.
• Safety and effectiveness in Class III (Contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily, and the subject device should only be used on closed surgical incisions.
• The device has not been demonstrated to reduce deep incisional and organ space surgical site infections.
• The device has not been demonstrated to be effective in reducing the incidence of surgical site infection and seroma in all surgical procedures and patient populations; therefore, the device may not be recommended for routine use to reduce the incidence of surgical site infection and seroma.
• Please refer to the 'Summary of Clinical Information' section for the specific surgical procedures and patient populations included in the clinical studies. Surgeons should continue to follow the 'Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection'2 and the 'American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines' for best practices in preventing surgical site infection.

PREVENA™ Dressings (13cm, 20cm, 35cm, CUSTOMIZABLE™):
The PREVENA™ 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 exudates via the application of negative pressure wound therapy.

Sensitivity to silver: Note: the interface layer of the 3M™ Prevena Dressings contain 0.019% silver to help reduce bacterial colonization in the fabric. It is not intended for treating infection at the incision site.

Before applying the 3M™ Prevena™ Incision Management System to patients who are at risk of bleeding complications due to the operative procedure or concomitant therapies and/or co-morbidities, ensure that homeostasis has been achieved and all tissue planes have been approximated. If active bleeding develops suddenly or in large amounts during therapy, or if frank blood is seen in the tubing or canister, the patient should leave the Incision dressing in place, turn off Therapy Unit and seek immediate emergency medical assistance. As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection or other complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge, or strong odor. Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock, and/or fatal injury. Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension, or erythroderma (a sunburn-like rash). Silver in the interface layer of the Incision Dressing is not intended to treat infection, but to reduce bacterial colonization in the fabric. If infection develops, therapy should be discontinued until the infection is treated. Remove the Incision Dressing if defibrillation is required in the area of the dressing placement. Failure to remove the dressing may inhibit transmission of electrical energy and/or patient resuscitation. The 3M™ Prevena™ Incision Management System is MR Unsafe. Do not take the Therapy Unit into the MR environment. The Incision Dressing can typically remain on the patient with minimal risk in an MR environment. Interruption of Therapy during an MRI may reduce the effectiveness of therapy. The Incision Dressing should pose no known hazards in an MR environment with the following conditions of use: static magnetic field of 3 Tesla or less, spatial gradient field of 720 Gauss/cm or less, and maximum whole-body-averaged specific absorption rate (SAR) of 3W/kg for 15 minutes of scanning. The Incision Dressing contains metallic silver that may impair visualization with certain imaging modalities. Do not take the 3M™ Prevena™ Incision Management System or Incision Dressing into a hyperbaric oxygen chamber; it is not designed for this environment and should be considered a fire hazard. If therapy is reinitiated after HBO treatment, do not readhere the same dressing; a new dressing must be reapplied. If at any time while using the 3M™ Prevena™ Incision Management System, the canister becomes full of fluid other than blood, indicated by a Maximum Capacity Alert or visual inspection, the patient should turn therapy unit off and contact the treating physician.

Allergic Response: The Incision Dressing has an acrylic adhesive coating and a skin interface layer with silver, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives or silver. If a patient has a known allergy or hypersensitivity to these materials, do not use the 3M™ Prevena™ Incision Management System. If any signs of allergic reaction, irritation, or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus, patient should consult a physician immediately. If bronchospasm or more serious signs of allergic reaction appear, the patient should turn off the therapy unit and seek immediate emergency medical assistance.

Do not expose to high temperature (60°C/140°F).