The FDA Approves ARTISS For Rhytidectomy Surgery
Baxter International Inc. announced 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 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.
For more information, visit www.baxter.com.