Absorbable Dressing for Heart Surgery Gets FDA OK
by
Brendon Nafziger, DOTmed News Associate Editor | April 12, 2010
Absorbable dressing
for heart surgery
Nycomed's absorbable dressing for heart surgery is now coming to America. The company's biodegradable sealant that stops bleeding of small blood vessels received U.S. Food and Drug Administration clearance last week, the federal agency announced.
Called Tachosil, the patch creates a fibrous seal that adheres to blood vessels broken during surgery. It also contains agents that help blood coagulate, thereby staunching bleeding.
According to the Zurich, Switzerland-based Nycomed, clots form in about three to five minutes after application. And after three to six months, the patch is harmlessly absorbed by the body. The FDA has approved Tachosil for situations where normal techniques, like suturing, aren't enough to stop bleeding.
The new product, available in much of Europe since 2004 and already out in Asia, is the next-generation version of Tachocomb, Nycomed's earlier sealant which used a mixture of human and cow-derived agents to help blood clotting. In Tachosil, all clotting agents are human-derived.
"This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical," FDA's Dr. Karen Midthun, acting director of their Center for Biologics Evaluation and Research, said in a statement.
The collagen in the patch is made from horse tendons, and the two clotting substances, thrombin and fibrinogen, are derived from human blood plasma. The plasma, taken from U.S. donors, is screened for diseases, according to the FDA. And the horse collagen is processed to remove any possible contaminants or viruses.
According to the FDA, a study involving 119 cardiovascular surgery patients found 75 percent stopped bleeding in under three minutes using the dressing, compared with only 33 percent of the patients who weren't treated with the pro-clotting sealant.
In Europe, Tachosil is also approved for helping to seal the surface of internal organs, such as the liver and kidney, during surgery.
