FDA OKs novel surgical clotting solution

Jan 17, 2008

The U.S. Food and Drug Administration announced approval Thursday of the first clotting solution made using recombinant DNA techniques.

The FDA said the new solution, called Recothrom, is a topical solution designed to stop small blood vessels from bleeding following surgery. Recombinant DNA is the result of a genetic modification process that enables scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

The FDA said post-surgical bleeding from small blood vessels, such as capillaries, can cause significant blood loss. Physicians can apply Recothrom during surgery when standard surgical techniques for stopping blood loss are ineffective or impractical.

"With today's approval, surgeons can choose recombinant thrombin, thrombin derived from human plasma or thrombin derived from cattle plasma to help control surgical bleeding and oozing," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.

Recothrom is made from Chinese hamster ovary cells that have been genetically modified to produce human thrombin. The cells are free from known infectious agents, the FDA said, noting Recothrom undergoes an additional process of viral inactivation.

Recothrom is manufactured by ZymoGenetics Inc. of Seattle.

Copyright 2008 by United Press International

Explore further: Were clinical trial practices in East Germany questionable?

add to favorites email to friend print save as pdf

Related Stories

MasterCard, Zwipe announce fingerprint-sensor card

13 hours ago

On Friday, MasterCard and Oslo, Norway-based Zwipe announced the launch of a contactless payment card featuring an integrated fingerprint sensor. Say goodbye to PINs. This card, they said, is the world's ...

Plastic nanoparticles also harm freshwater organisms

14 hours ago

Organisms can be negatively affected by plastic nanoparticles, not just in the seas and oceans but in freshwater bodies too. These particles slow the growth of algae, cause deformities in water fleas and impede communication ...

Atomic trigger shatters mystery of how glass deforms

14 hours ago

Throw a rock through a window made of silica glass, and the brittle, insulating oxide pane shatters. But whack a golf ball with a club made of metallic glass—a resilient conductor that looks like metal—and the glass not ...

US company sells out of Ebola toys

23 hours ago

They might look tasteless, but satisfied customers dub them cute and adorable. Ebola-themed toys have proved such a hit that one US-based company has sold out.

Recommended for you

Were clinical trial practices in East Germany questionable?

Oct 23, 2014

Clinical trials carried out in the former East Germany in the second half of the 20th century were not always with the full knowledge or understanding of participants with some questionable practices taking place, according ...

Schumacher's doctor sees progress after injury

Oct 23, 2014

A French physician who treated Michael Schumacher for nearly six months after the Formula One champion struck his head in a ski accident says he is no longer in a coma and predicted a possible recovery within three years.

User comments : 0