FDA Clears LeGoo for Surgical Blood Flow Control

 

October 17, 2011

October 17, 2011 — The U.S. Food and Drug Administration (FDA) has approved LeGoo, a gel allowing surgeons to temporarily stop blood flow during surgery. This makes it possible to 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 of the surgical area, which makes it difficult for the surgeon to clearly see where to place sutures.

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.”

The temperature-sensitive gel is liquid at room temperature and solid beyond that. When injected into a blood vessel, it 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 should dissolve on its own in 15 minutes. In the event it needs to dissolve sooner, the surgeon can apply a cold pack or cold saline to the blood vessel.

In support of approval of the pre-marketing application, the FDA reviewed studies showing LeGoo is biocompatible and non-toxic. The agency 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 the gel is as safe and effective as vessel loops, devices commonly used to stop blood flow during coronary bypass surgery.

It 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.

For more information: www.fda.gov/medicaldevices

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