FDA NEWS RELEASE
For Immediate Release: Oct. 4, 2011
Media Inquiries: Karen Riley, 301-796-4674, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves gel to stop blood flow during blood vessel surgery
The U.S. Food and Drug Administration has approved LeGoo, a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops.
To join blood vessels during surgery, it is necessary to temporarily stop blood flow to the area where a new vessel is being attached. Stopping blood flow prevents flooding the surgical area with blood, which makes it difficult for the surgeon to clearly see where to place sutures to connect the two vessels.
LeGoo has been shown to minimize blood flow into the surgical area without damaging blood vessels. Standard tools, such as elastic loops and clamps, do not always allow for a bloodless surgical area and may damage vessels.
“LeGoo is an innovative device that offers surgeons an additional aid during vascular surgery,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The gel’s unique properties may facilitate surgeries that entail the joining or grafting blood vessels.”
LeGoo is a temperature sensitive gel that is liquid at room temperature and solid at higher temperatures. When injected into a blood vessel, LeGoo forms a gel plug that molds to the shape of the blood vessel and stops blood flow for up to 15 minutes.
After the blood vessels are joined, the plug is expected to dissolve on its own in 15 minutes. In the event the plug needs to dissolve sooner, the surgeon can dissolve the gel plug by applying a cold pack or cold saline to the blood vessel.
In support of approval of the pre-marketing application, the FDA reviewed studies showing that LeGoo is biocompatible and non-toxic. The FDA also looked at data from a clinical trial of 110 patients undergoing bypass surgery without stopping the heart (off pump coronary artery bypass). Investigators found that LeGoo is as safe and effective as vessel loops, devices commonly used to stop blood flow during coronary bypass surgery.
LeGoo is approved for temporarily stopping blood flow in blood vessels below the neck that are 4 millimeters or less in diameter. It is contraindicated for use on vessels supplying blood to the brain.
LeGoo is manufactured by PluroMed Inc. of Woburn, Mass.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.