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FDA OKs gel to stop blood flow during surgery

Article-FDA OKs gel to stop blood flow during surgery

Washington — The Food and Drug Administration (FDA) has approved LeGoo, a gel that allows surgeons to stop blood without clamps or elastic loops so that blood vessels can be joined.

LeGoo (biocompatible reverse thermosensitive polymers, PluroMed) is a temperature-sensitive gel that is liquid at room temperature and solid at higher temperatures. When injected into a blood vessel, it forms a plug that molds to the shape of the vessel and stops blood flow for up to 15 minutes, then dissolves. If faster dissolution is needed, the surgeon can dissolve the gel plug by applying a cold pack or cold saline to the blood vessel.

An FDA news release states approval of LeGoo is based on studies showing that the gel is biocompatible and nontoxic. The agency also reviewed data from a clinical trial of 110 heart patients who had undergone bypass surgery during which the heart was not stopped. Investigators found LeGoo to be as safe and effective as vessel loops, devices commonly used to stop blood flow during such surgeries.

LeGoo is approved for temporarily stopping blood flow in blood vessels below the neck that are no more than 4 millimeters in diameter. It is contraindicated for use on vessels supplying blood to the brain.

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