The FDA has approved LeGoo from Pluromed, a gel that allows surgeons to temporarily stop blood flow during surgery involving blood vessels.
The temperature-sensitive gel forms a plug when injected in the bloodstream, stopping blood flow during surgery for up to 15 minutes, allowing surgeons to join blood vessels without clamps or elastic loops.
In cases where 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.
The gel has been shown by clinical trials to avoid blood vessel damage and prevent blood flooding in the surgical area.
“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 FDA based the approval on studies showing that LeGoo is both biocompatible and non-toxic. Clinical trials involving 110 patients undergoing bypass surgery without stopping the heart proved that LeGoo was as safe and effective as vessel loops, commonly used to stop blood flow during coronary bypass surgery.
Based in Massachussetts, USA, Pluromed specialises in injectable plugs to control bleeding during surgery, based on its proprietary polymer technology.
Pluromed is not yet showing this approval on its website, but does confirm that the product is CE marked and was shown at the 2010 EACTS congress in Geneva.
Source: Medtechbusiness, Pluromed