LeGoo® - P110003
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: LeGoo®
PMA Applicant: Pluromed, Inc.
Address: Woburn, MA
Approval Date: September 28, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110003a.pdf
What is it? LeGoo is intended to be used during surgical procedures to temporarily plug a blood vessel and stop blood flow. It is comprised of a non-toxic gel that dissolves completely by water and has heat-sensitive properties. At room temperature, it is a thick, injectable liquid. The device transitions to a temporary self-forming plug when it is injected into the body. The material undergoes a temperature-induced change without any alteration in the product’s chemical composition. Once inside the blood vessel, the material temporarily remains a plug, and then dissolves.
How does it work? LeGoo is injected into a blood vessel that is intended to be plugged. The amount of LeGoo injected into the blood vessel is determined by the size of the vessel. A hole is made at a desired location, the tube-like device (cannula) is inserted inside, and LeGoo is injected.
When LeGoo is injected into the blood vessel, the thickness increases due to the rise in temperature and a plug is formed in the vessel, temporarily preventing blood flow. The plug lasts for about 15 minutes allowing the surgeon to work in a bloodless environment. If left in place and not removed, the plug will dissolve in approximately 15 minutes, or blood flow may be restored by cooling the area with sterile ice or injecting a cold solution containing salt.
When is it used? LeGoo is intended for the temporary stoppage of blood during surgical procedures. LeGoo is indicated for temporary blockage of blood vessels below the neck up to and including 4 mm in diameter.
What will it accomplish? LeGoo temporarily stops blood flow to allow for a better surgical environment.
When should it not be used? This product should not be used in patients with vascular anatomy or blood flow that does not allow cannula placement or proper injection and control of LeGoo.
Additional information: Summary of Safety and Effectiveness and labeling are available online.