Gel to Control Bleeding During Surgery Gets FDA Nod

Megan Brooks

October 04, 2011

October 4, 2011 — The US Food and Drug Administration has approved a gel that allows surgeons to temporarily stop blood flow during vascular and cardiovascular surgery without using clamps or elastic loops, which can damage blood vessels.

The gel, called LeGoo, is manufactured by PluroMed Inc, of Woburn, Massachusetts.

LeGoo is a water-soluble, temperature-sensitive gel that is liquid at room temperature. 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, the FDA notes in a statement released today.

Suturing can be performed directly through the gel. Upon completion, LeGoo is dissolved by applying ice directly to the vessel. The diluted material will not re-gel once it is dissolved: it passes through the microcirculation and is excreted in urine.

'Innovative Device'

Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement that LeGoo is "an innovative device that offers surgeons an additional aid during vascular surgery. The gel's unique properties may facilitate surgeries that entail the joining or grafting blood vessels."

Studies have shown that LeGoo is "biocompatible and non-toxic," the FDA notes. Data from a clinical trial of 110 patients who underwent off-pump coronary artery bypass surgery showed the compound to be "as safe and effective as vessel loops," the FDA says.

LeGoo is approved for temporarily stopping blood flow in blood vessels below the neck that are 4 mm or smaller in diameter. It is contraindicated for use on vessels supplying blood to the brain.