Navigation Links
Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients

Biologically active tissue adhesive allows for placement of skin grafts

without staples or sutures

DEERFIELD, Ill., March 20 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation announced today the U.S. Food and Drug Administration (FDA) approval of ARTISS (Fibrin Sealant (Human)), the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. ARTISS was developed using Baxter's proven fibrin sealant technology platform and is the newest agent in the company's expanding BioSurgery portfolio.

ARTISS allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds, relative to rapid-setting fibrin sealants, which set in five to 10 seconds. Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal. Baxter will launch ARTISS at the American Burn Association (ABA) 40th Annual Meeting held April 29 -- May 2, 2008 in Chicago.

"ARTISS is a safe and effective alternative to staples, reducing discomfort among burn patients requiring skin grafts," said Ron Lloyd, general manager, BioSurgery. "This is another example of Baxter's scientific leadership in specialty biologic products, serving needs of patients and physicians."

The FDA approval is based on Phase III study results, which were also 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. ARTISS is safe and effective for attaching skin grafts with outcomes as good as staple fixation.

Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures.

ARTISS is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin. It 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, thus enabling application in a thin and even layer.

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.

Please see ARTISS Prescribing Information for full prescribing details.

About Baxter

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

ARTISS is a trademark of Baxter International Inc.

SOURCE Baxter Healthcare Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Baxters Board of Directors Approves New Share Repurchase Authorization of $2 Billion
2. Baxter and Its Foundation Contribute Nearly $53 Million in 2007 to Address Critical Needs Locally and Globally
3. Baxter to Proceed With Recall of Remaining Heparin Sodium Vial Products
4. Baxter Declares Quarterly Dividend
5. Baxter Provides Update on Heparin Reactions
6. Baxters Costa Rica Facility Recognized With Shingo Prize for Excellence in Manufacturing
7. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
8. Baxter International Fourth Quarter 2007 Financial Results Conference Call
9. Baxter Announces FDA Approval of GELFOAM(R) Plus Hemostasis Kit
10. Baxter Receives 510(k) Clearance From FDA For V-Link With VitalShield, New Antimicrobial Intravascular Technology
11. Baxter Kidney Patient Education Program Celebrates Tenth Anniversary
Post Your Comments:
(Date:11/27/2015)... India , November 27, 2015 /PRNewswire/ ... --> Growing popularity of companion diagnostics ... in cancer biomarkers market with pharmaceutical companies ... in-demand companion diagnostic tests. ... --> Complete report on global cancer ...
(Date:11/25/2015)... 2 nouvelles études permettent d , identifier ... souches bactériennes retrouvées dans la plaque dentaire des ... Ces recherches  ouvrent une nouvelle voie ... l,un des problèmes de santé les plus fréquemm ... --> 2 nouvelles études permettent d , ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... of Black Aerospace Professionals (OPBAP) has been formalized with the signing of a ... leaders met with OPBAP leaders Capt. Karl Minter and Capt. Albert Glenn Tuesday, ...
(Date:11/24/2015)... HILLS, N.J. (PRWEB) , ... November 24, 2015 , ... ... as the recipient of the 2016 USGA Green Section Award. Presented annually since 1961, ... golf through his or her work with turfgrass. , Clarke, of Iselin, ...
Breaking Biology Technology:
(Date:11/17/2015)... Paris from 17 th ... Paris from 17 th until 19 th ... leader, has invented the first combined scanner in the world ... scanning surface. Until now two different scanners were required: one ... both on the same surface. This innovation is an ...
(Date:11/16/2015)... , Nov 16, 2015  Synaptics Inc. ... human interface solutions, today announced expansion of its ... ™ touch controller and display driver integration ... of smartphones. These new TDDI products add to ... (HD resolution), TD4302 (WQHD resolution), and TD4322 (FHD ...
(Date:11/11/2015)... , Nov. 11, 2015   MedNet Solutions , ... spectrum of clinical research, is pleased to announce that it ... Clinical Trials (PCT) event, to be held November 17-19 ... able to view live demonstrations of iMedNet ... learn how iMedNet has been able to deliver ...
Breaking Biology News(10 mins):