Proven Efficacy and Safety
As the first and only fibrin sealant custom designed for tissue adherence in plastic, reconstructive and burn surgery, ARTISS has been proven safe and effective in a pivotal phase 3, multicenter, prospective, randomized, clinical study.1
Mechanism of Action
ARTISS is a two component fibrin sealant, consisting of human thrombin and human fibrinogen and an antifibrinolytic inhibitor to delay clot degradation.2
Upon mixing, soluble fibrinogen is transformed into a fibrin matrix that adheres to the wound surface and to the skin graft to be affixed.2
Initial polymerization of ARTISS will take up to 60 seconds; allowing time to manipulate and position the graft prior to polymerization.2
The adhesive properties of ARTISS provide full surface adherence of the graft to the wound bed, closing the space that exists when
grafts are attached using point fixation techniques such as staples.1
ARTISS eliminates the need for staple application or removal.1
Additional Product Benefits
Significantly Reduced Drainage Volume
In facial rhytidectomy, drainage volume was reduced on average by 62%, when evaluated 24 hours (+/- 4h) post surgery, when ARTISS was used with the standard of care (SoC) vs. SoC alone (7.7 ± 7.4 mL vs 20.0 ± 11.3 mL (p < 0.0001), n=75). ARTISS may also eliminate the need for surgical drains.1
Effective for Complete Wound Closure
In burn surgeries, ARTISS has been demonstrated to be at least as efficacious as staples, with 43.3% of sites achieving full wound closure by day 28 compared to 37.0% for staples.2
Flexible and Convenient
ARTISS allows up to 60 seconds to manipulate and position the tissue flap. In addition, it doesn’t require any mixing or reconstitution, and it may be stored for 14 days unopened at room temperature (after removal from the freezer, and thawed at room temperature.)1
ARTISS [Fibrin Sealant (Human)] Indication
ARTISS is a fibrin sealant 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 directly into blood vessels. Intravascular application can result in life threatening thromboembolic events.
Do not use in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active
substances or excipients.
Hypersensitivity reactions, including anaphylaxis, can occur. Cases have been reported in post-marketing
experience with fibrin sealant. 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.
Discontinue administration in the event of 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.
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, the variant
Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse reactions in the facial rhytidectomy studies occurring in greater than 1% of subjects treated with ARTISS
were hematoma/seroma (4%).