InnovaMatrix® Advanced Care (AC) is the first-ever placental-derived medical device cleared by the FDA for wound management.
• Preserves the inherent benefits of the placenta while adding the reliability, reproducibility and safety profile of a regulated medical device
• Thoroughly decellularized
• Controlled material source
• No product preparation required
• Easy to use
• No specific orientation for placement
• Ambient temperature storage
• Affordable
InnovaMatrix® AC is for use on: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, 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 in third-degree burns.
Do not use if packaging is compromised or damaged.
Single patient, single use only. Discard all open and unused portions of InnovaMatrix® AC.
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
This device should be stored in a clean, dry environment at room temperature in its unopened and undamaged original packaging.
Acute Wounds
Burns
Chronic Wounds
Dehisced Wounds
Diabetic Foot
Non/Minimally Exudating Wounds
Pressure Ulcers
Surgical Wounds
Venous Ulcers
InnovaMatrix® AC 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 InnovaMatrix® AC, only change the primary dressing as necessary, typically every seven days. Change the secondary dressing as appropriate. Take care to avoid dislodging the InnovaMatrix® AC when the secondary dressing is changed.
Latex-friendly
Non-immunogenic
Non-irritating
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