A gel that allows surgeons to temporarily stem blood flow during surgery has been approved by the US Food and Drug Administration.
According to a statement, a gel that allows surgeons to temporarily stem blood flow during surgery has been approved by the US Food and Drug Administration (FDA).
The purpose of LeGoo, the blood stopping gel, is to allow surgeons to join blood vessels during surgery without having to use clamps or elastic loops.
The gel has been approved for the use on vessels below the neck that are 4 millimeters or less in diameter, but it is not advisable for use on vessels supplying blood to the brain.
LeGoo has demonstrated the ability to drastically reduce blood flow into the surgical area without damaging blood vessels. This is a step up for patient care from standard tools, such as elastic loops and clamps, which do not consistently minimize blood flow into the surgical area and have potential to damage vessels.
“LeGoo is an innovative device that offers surgeons an additional aid during vascular surgery,” reported 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 gel is temperature sensitive. It is liquid at room temperature, but solid at higher temperatures, so when is it injected into a blood vessel, it forms a “plug” that molds to the shape of the blood vessel, effectively stopping blood flow for up to 15 minutes.
After 15 minutes (once the blood vessels are joined) the plug dissolves on its own, but should the surgeon require it to dissolve sooner, a cold pack or cold saline can be applied to the vessel.
The FDA reviewed studies that have found LeGoo to be biocompatible and non-toxic. The FDA also examined data from a clinical trial on 110 patients who underwent off pump coronary artery bypass. The researchers of this trial found that LeGoo was just as safe and effective as vessel loops.