Sunday, March 2, 2008

Woundstat

WoundStat was developed in VCU Medical Center's Reanimation Engineering Shock Center, which does research on treating critical illness and injury. Part of the center, Operation Purple Heart, focuses on treating combat casualties.
"We took a step back and examined what the strengths and weaknesses were with the current (blood-stopping) products that were out there to see if there was something we could improve upon," said Dr. Kevin Ward, an emergency physician and the shock center's associate director.
Ward and two colleagues - biochemist Robert Diegelmann and biomedical engineer Gary Bowlin - developed a tan-colored concoction of minerals that looks like a cross between flour, sand and cat litter. After its use, WoundStat can be peeled off the wound.
The researchers were introduced to Jack McDonnell, who licensed the technology and established a company called TraumaCure in May 2006.
McDonnell expects the Food and Drug Administration to approve WoundStat by October, after which TraumaCure will market its product to the military, firefighters and police departments.
Blanck, the retired surgeon general and an outside director of TraumaCure, said current hemorrhage-stopping products - specifically, HemCon and QuikClot - have been a step in the right direction but that there is room for improvement.
"I'm not critical of them because I think they've been responsible for saving lives. Our goal is to save even more," he said.
A spokeswoman for HemCon said its standard-issue bandages work best on large, high-blood flow wounds but are limited on smaller but serious injuries such as a gunshot. QuikClot clots blood but produces a reaction when used that creates excessive heat, and studies have found that it may damage organs and tissues.
An independent study by the Army's Institute of Surgical Research found WoundStat to be a highly effective wound dressing that doesn't produce a heat reaction. The report said the product's primary limitation is that it will stop blood flow on damaged vessels, acting as a granular tourniquet in areas where an actual tourniquet cannot be tied, such as the groin.
Please find the FDA 510K approved 2007 HERE

Marketing of Trasylol Suspended

Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

"The" 5 Ideal Hemostat Characteristics

1. First, the ideal hemostatic agent would of course be such that the agent itself is as well as any of its metabolic breakdown products would be safe to use within the body.
2. Second, you want it to work and you want it to be efficacious.The definition of efficacy can vary between the different uses, for example a vascular surgeon may want something that polymerizes very quickly in order to stop bleeding, but does not cause clot of the vessel that they spent all this time anastomosing, where as a reconstructive surgeon for example may want something that polymerizes very slowly to give them time to reposition their flaps or grafts.
3. Third is usability; you want something that is easy to use and that you can use in a variety of different circumstances.
4. Fourth is affordability. This may be more relevant to a hospital administrator or pharmacist who actually does the purchasing, but it impacts the surgeon because that determines what you have available to you in the operating room.
5. And finally, fifth, approvability. Any of these agents need to be approved by the FDA in order to be used in the US.