Navigation Links
Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients
Date:3/20/2008

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. http://www.baxter.com/products/downloads/ARTISS_PI.pdf

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:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... ... , ... Disappearing forests and increased emissions are the main causes of the ... Especially those living in larger cities are affected by air pollution related diseases. , ... pollution-affected countries globally - decided to take action. , “I knew I had to ...
(Date:10/10/2017)... ... October 10, 2017 , ... For the second ... a US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled to Washington, ... from US2020. , US2020’s mission is to change the trajectory of STEM education ...
(Date:10/10/2017)... ... 10, 2017 , ... The Pittcon Program Committee is pleased ... scientists who have made outstanding contributions to analytical chemistry and applied spectroscopy. Each ... leading conference and exposition for laboratory science, which will be held February 26-March ...
(Date:10/9/2017)... ... October 09, 2017 , ... ... journal, Epilepsia, Brain Sentinel’s SPEAC® System which uses the surface electromyography (sEMG) ... tonic-clonic seizures (GTCS) using surface electromyography (sEMG). The prospective multicenter phase III ...
Breaking Biology Technology:
(Date:5/16/2017)... , May 16, 2017  Veratad Technologies, LLC ( ... online age and identity verification solutions, announced today they ... Conference 2017, May 15 thru May 17, 2017, in ... and International Trade Center. Identity impacts ... and in today,s quickly evolving digital world, defining identity ...
(Date:4/19/2017)... New York , April 19, 2017 ... competitive, as its vendor landscape is marked by the ... the market is however held by five major players ... Safran. Together these companies accounted for nearly 61% of ... of the leading companies in the global military biometrics ...
(Date:4/13/2017)... -- According to a new market research report "Consumer IAM ... and Authorization), Service, Authentication Type, Deployment Mode, Vertical, and Region - Global ... grow from USD 14.30 Billion in 2017 to USD 31.75 Billion by ... ... MarketsandMarkets Logo ...
Breaking Biology News(10 mins):