DEERFIELD, Ill., AUGUST 31, 2011 - Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication of ARTISS [Fibrin Sealant (Human)] to include adhering tissue flaps during facial rhytidectomy surgery (face-lift). ARTISS is the only premixed, ready-to-use fibrin sealant specifically indicated for tissue adherence in facial rhytidectomy (face-lift) and burn surgeries. It was first approved by the FDA in 2008 to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations one year of age or older.
"The use of ARTISS in this indication gives surgeons a useful tool to enable full-surface adherence of tissue flaps during surgery, minimizing areas of dead space, and significantly reducing drainage volumes when compared to standard of care," said Dr. Thomas Mustoe, Professor at Northwestern University Feinberg School of Medicine.
In traditional face-lift procedures, sutures are used to close the flap of skin at its edge, often leaving a space underneath the tissue that can lead to post-operative complications. ARTISS sets within 60 seconds, giving surgeons time to manipulate and accurately position the skin flap. ARTISS contains blood plasma proteins essential to clot formation.
"The FDA approval of the facial rhytidectomy indication for ARTISS gives surgeons the flexibility to use it as an adjunct to sutures in patients undergoing face-lift surgery," said Steve Zvi Abrams, M.D., medical director for Baxter's BioScience business. "The new indication expands on the previous clinical experience in burn surgeries, through which we were able to build on our knowledge and deliver improved clinical outcomes for other surgical patients who may be able to benefit from ARTISS administration."
A phase III clinical study presented earlier this year assessed the safety and efficacy of ARTISS for face-lift surgery in 75 patients, comparing the total drainage volume for each side of the face at 24 hours following surgery. In the study, ARTISS was applied as an adjunct to sutures with the goal of improving flap adherence as indicated by reduced post-operative drainage. The study found ARTISS reduced total drainage volumes at 24 hours following face-lift surgery compared with standard of care (sutures alone) without the use of pressure dressings (which were not permitted in the study). Adverse reactions in the facial rhytidectomy studies occurring in greater than 1% of subjects treated with ARTISS were hematoma/seroma occurring in 4% of subjects.
ARTISS was recently approved for plastic, burn and reconstructive surgeries in 15 European countries (UK, Czech Republic, Germany, Italy, Sweden, Norway, Finland, Denmark, Netherlands, Portugal, Hungary, Iceland, Poland, Spain and Austria). Canada, Switzerland, Australia and Taiwan have approved ARTISS for burn surgery.
ARTISS [Fibrin Sealant (Human)], Vapor Heated, Solvent Detergent Treated, (ARTISS) is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein (Human) and Thrombin (Human), mimic the final stage of the blood coagulation cascade. In the U.S., 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 also indicated to adhere tissue flaps during facial rhytidectomy surgery (face-lift). ARTISS is not indicated as an adjunct to hemostasis. In Europe, ARTISS is indicated as a tissue glue to adhere/seal subcutaneous tissue in plastic, reconstructive and burn surgery, as a replacement or an adjunct to sutures or staples. In addition, ARTISS is indicated as an adjunct to hemostasis on subcutaneous tissue surfaces. In Canada, ARTISS is currently indicated for the fixation (glue) of autologous skin grafts and skin flaps and adjunct to hemostasis on subcutaneous tissue surfaces to treat burns in adult and pediatric patients.
Important Risk Information
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 have been reported 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 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.
For full prescribing information, please visit: http://www.baxter.com/downloads/healthcare_professionals/
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.