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.