InnovaBurn® is designed to help manage partial-thickness, second-degree burns. Part of the InnovaMatrix® family of products that are the first and only placental-derived medical devices cleared by the FDA for wound management.
• Offers the inherent benefits of the placenta plus the quality control, reliability, and safety profile of a medical device
• Manufactured with proprietary TriCleanse™ Placental Extracellular Matrix (ECM) Process
• Next-generation placental ECM designed for the management of partial-thickness, second-degree burns; hard-to-heal wounds; and complex surgical wounds
• No preparation required
• No specific placement orientation
• Ambient temperature storage
• No tissue tracking
• Affordable
InnovaBurn® is for use on partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wound, surgical wounds (donor sites/grafts, post-Mohs surgery, post- laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), partial-thickness second degree burns, or draining wounds.
This device is derived from porcine collagen and should not be used on patients with: sensitivity or allergy to porcine materials; sensitivity or allergy to collagen; or active or latent infection in or around the application site.
This device is not indicated for use on full-thickness burns and third-degree burns.
Do not use if packaging is compromised or damaged.
Single patient, single use only. Discard all open and unused portions of InnovaBurn®.
Always use aseptic technique when handling the device.
Do not re-sterilize.
Do not use if expiration date has been exceeded.
Do not apply until excessive exudate, bleeding, acute swelling and infection is controlled.
The following complications are possible. If any of these conditions occur, the device should be removed.
• Allergic reaction
• Pain, swelling, excessive redness, or blistering
• Chronic inflammation (initial application of wound dressings may be associated with transient, mild, localized inflammation)
• Infection
Ambient temperature storage.
Acute Wounds
Burns
Chronic Wounds
Dehisced Wounds
Diabetic Foot
Non/Minimally Exudating Wounds
Pressure Ulcers
Surgical Wounds
Venous Ulcers
InnovaBurn® consists of extracellular matrix derived from porcine placental material. The device is supplied in a variety of sterile sheet configurations. It is packaged in double peel-open packages and is intended for single use only. The device is terminally sterilized using E-Beam sterilization and is for licensed health care practitioner use only.
To prevent damage to the newly incorporating InnovaBurn®, only change the primary dressing as necessary, typically every seven days. Change the secondary dressing as appropriate. Take care to avoid dislodging the InnovaBurn® when the secondary dressing is changed.
Latex-friendly
Non-immunogenic
Non-irritating
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