April 28, 2017
The GalaForm 3D surgical scaffold, which can be used in plastic and reconstructive surgery, has garnered FDA 510K clearance, according to a statement from Galatea Surgical.
The product is based on P4HB bioresorbable polymer technology from Tepha Inc., according to the statement. The scaffold has a reinforcing rim that has the capacity to uplift the body’s natural shape, is easier to place than other scaffolds, and offers a shortened procedure duration, according to the statement. The FDA indication is for soft tissue support along with repairing, elevating and reinforcing soft tissue in areas that require it.