Plastic surgeons and other physicians who treat burn victims have a new kind of adhesive available for attaching skin grafts.
Artiss, a slow–setting fibrin sealant developed by Baxter Healthcare (Deerfield, Illinois), enables the delayed setting and controlled manipulation of skin grafts for about 60 seconds, relative to rapid–setting fibrin sealants, which are fixed in five to 10 seconds, according to the company.
Baxter says that these skin grafts can be attached with Artiss without the use of staples or sutures, thus helping to reduce post–operative complications and patient anxiety about pain during staple removal.
"Artiss enables surgeons time to manipulate skin grafts, which allows for greater control and precision in placement of skin grafts," Laura Grossmann, a spokeswoman for Baxter, told Medical Device Daily. "Fast–setting fibrin sealants — which are the only ones on the market to date — do not have the capacity for a prolonged setting time. Artiss is the only fibrin sealant approved for the adherence of skin grafts in burn patients; other fibrin sealants are not approved for this specific use."
Fibrin sealants are made of proteins fibrinogen and thrombin, which are essential in blood clotting. Artiss contains a lower concentration of thrombin, which is what enables the slow set feature of this adhesive. Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots.
Fibrinogen and thrombin proteins in Artiss are derived from human plasma, collected from plasma centers.
"Baxter is committed to patient safety. The fibrinogen and thrombin proteins in Artiss, derived from human plasma, are collected from FDA–licensed plasma centers," Grossmann said.
"Both proteins undergo purification and virus inactivation treatments to reduce the risk of blood–transmissible infections."
The FDA approval is based on Phase III study results, published in the March/April 2008 issue of The Journal of Burn Care and Research. The multi–center, prospective, randomized, controlled and blinded study compared the use of Artiss to staples in 138 burn patients requiring skin grafting. The study found that Artiss is safe and effective for attaching skin grafts with outcomes as good as staple fixation.
Frequent adverse events, seen in both treatment groups in the study, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures.
Artiss will be available in two forms: a pre–filled syringe (frozen) formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, enabling application in a thin and even layer.
There are about 500,000 burn injuries a year in the U.S. each year, according to the American Burn Association (Chicago). Of those about 25,000 require a skin grafts, which is the potential market size for Artiss, Grossmann said.
Fibrin sealants are not new to the market and have been used in a variety of other applications.
For example, the FDA recently expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery (Medical Device Daily, Jan. 18, 2008). Evicel is sprayed or dripped on small, oozing blood vessels. Evicel is made by Omrix Biopharmaceuticals (Kiryat, Israel).
Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery.
In the same space, Ethicon (Somerville, New Jersey) reported that the FDA granted an expanded indication for Evicel Fibrin Sealant, indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical (MDD, Jan. 14, 2008).
But Artiss is different from other fibrin sealants. In fact, the FDA published its own announcement about the Artiss approval, a move that's typically reserved for important or breakthrough product approvals.
"The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "The approval also provides an additional choice for healthcare professionals in providing burn treatment."
Grossmann said Baxter is still evaluating the final pricing for ARtiss, as well as a clinical development program for other indications.