Galatea Surgical, a subsidiary of Tepha Inc., announced in April that it has received FDA clearance for the GalaFORM 3D surgical scaffold, which they say is the only three-dimensionally contoured surgical scaffold with a reinforced rim.
“GalaFORM 3D is an extension of the GalaFLEX scaffold that we have had a lot of success with,” Bruce Van Natta, M.D. a plastic surgeon in private practice in Indianapolis, Ind., tells Cosmetic Surgery Times. “The difference is that the GalaFORM 3D is curved to fit the body’s natural shape and has a reinforcing rim around the edges to help maintain the 3-dimensional shape.”
Dr. Van Natta says it can be difficult to form a 2-dimentional flat sheet to fit a curved body surface. “But since the GalaFORM 3D is already curved and shaped, it is much easier and faster to place,” he says. “It allows us as surgeons to better shape and lift soft tissue during plastic and reconstructive surgery procedures.”
The scaffold is made of poly-4-hydroxybutyrate (P4HB), a unique biopolymer that is biologically derived, rather than obtained from human or animal tissue.
“The patient’s body naturally bioresorbs P4HB, leaving behind only strong, healthy supporting tissue made by the body itself,” Dr. Van Natta explains.
The reinforcing rim of the GalaFORM 3D is also made from the same P4HB material as the scaffold, “which resorbs naturally over the course of 18 to 24 months,” Dr. Van Natta says.
The scaffold can be used for a plastic or reconstructive surgical procedure, such as the breast or buttock that requires support, shape, lift and/or reinforcement.
Related: AeroForm for soft tissue expansion
The surgeon selects the optimal style and shape of scaffold before inserting at the time of surgery, where it is then sutured in place.
The new device offers surgeons the ability to maintain the results “we see on the table,” Dr. Van Natta says. In fact, “these are the best patient outcomes I have ever been able to achieve.”
The GalaFORM 3D scaffold allows surgeons “an anatomically optimal fit for certain soft tissues, which is unparalleled with any other available support mesh or acellular dermal matrix (ADM),” Dr. Van Natta says. “I believe this product will make soft tissue support easier to consistently maximize patient outcomes.”
Dr. Van Natta points out that GalaFORM 3D is a “game changer” for plastic surgery. “As surgeons, we are able to support weakened tissue and provide desired shape to that tissue to obtain excellent long-term results,” he says.