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Jan B. Wade · #1 (**permalink**) 03-21-2008, 10:49 PM

FDA News

March 21, 2008 | Vol. 5 No. 57

FDA Approves Baxter’s Artiss

Baxter Healthcare has received FDA clearance for its slow-setting Artiss fibrin sealant for use in adhering skin grafts in adult and pediatric burn patients.

Artiss allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds. Rapid-setting fibrin sealants set in five to 10 seconds.
The FDA approval is based on a multicenter, prospective, randomized, controlled Phase III study comparing the sealant with staples in 138 burn patients requiring skin grafting, Baxter said.

The article

hemostatguy · #2 (**permalink**) 03-30-2008, 10:53 PM

This product is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns, for both adults and pedi patients. It is not indicated for hemostasis.
The fibrinogen and thrombin proteins in Artiss are derived from human plasma, collected from FDA-licensed plasma centers. Both proteins undergo purification and virus inactivation treatments to reduce the risk of blood-transmissible infections.
However Baxters recent heparin scare makes one think alternative solutions without animal or human derivatives may be preferable if possible.

Jan B. Wade · #3 (**permalink**) 03-31-2008, 07:14 AM

This article was to show the advances being made in fibrin products. The mechanisms are the same as in the surgical product with the exception of the longer set time.

In my opinion autologous fibrin treatments are best as they use the patient own components thus lowering the risk.

Thanks for commenting.

hemostatguy · #4 (**permalink**) 03-31-2008, 04:27 PM

I concur if that is the case, from what I read its for attaching "autologous skin grafts" hence the risks of being infected with CJD.

Quote:

Important Safety Information

ARTISS (Fibrin Sealant (Human))

ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations.

ARTISS is not indicated for hemostasis.

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.

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.

Apply ARTISS as a thin layer. Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.

Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure and pruritus.

Full detail is available HERE

NoBlood

FDA Approves Baxter’s Artiss (fibrin sealant)