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ARTISS [Fibrin Sealant (Human)] Indications

ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age.

ARTISS is indicated to adhere tissue flaps during facial rhytidectomy surgery (face-lift).

ARTISS is not indicated as an adjunct to hemostasis.

Important Risk Information for ARTISS

For Topical Use Only. Do not inject ARTISS directly into blood vessels. Intravascular application of ARTISS may result in life-threatening thromboembolic events.

Do not use ARTISS in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substance or excipients.

Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of ARTISS. In specific cases, these reactions have progressed to become life-threatening.  Such reactions may especially be seen if ARTISS is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously; however, these reactions may also occur in patients receiving ARTISS for the first time. Symptoms associated with allergic anaphylactic reactions include: flush, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnea, severe hypotension and anaphylactic shock. Such reactions may also occur in patients receiving ARTISS for the first time.

Discontinue administration of ARTISS in the event of anaphylactic/-oid or hypersensitivity reactions.

Air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants. This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.

Apply only as a thin layer. Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.

Exposure to solutions containing alcohol, iodine or heavy metals may cause ARTISS to be denatured.

ARTISS is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse reactions in the burn studies occurring in greater than 1% of subjects treated with ARTISS were skin graft failure (3%), hematoma (1%) and pruritus (1%).

Adverse reactions in the facial rhytidectomy studies occurring in greater than 1% of subjects treated with ARTISS were hematoma/seroma (4%).

In the facial rhytidectomy studies, three subjects experienced serious adverse events (experiences).  Two were local:  wound abscess on the ARTISS treated side of the face that was recognized on postoperative day 14 and was treated by operative incision and drainage; and a case of basal cell carcinoma on the SoC treated side of the face.  A third subject experienced dehydration on the second postoperative day.


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