GalaForm 3D surgical scaffold receives FDA 510K clearance
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.
Galatea Surgical announced it planned to launch GalaForm 3D at the American Society for Aesthetic Plastic Surgery annual meeting April 27-May 2 in San Diego.
Galatea Surgical is a wholly owned subsidiary of Tepha. – by Rob Volansky