Tepha Inc subsidiary Galatea Surgical said today it won FDA 510(k) clearance for its GalaForm 3D surgical scaffold device designed for use in plastic and reconstructive surgery.
The Lexington, Mass.-based company claims that the GalaForm 3D scaffold is the only 3-dimensionally contoured surgical scaffold with a reinforcing rim designed to uplift the body’s shape for easier placement. The device is based on Tepha’s proprietary P4HB bioresorbable polymer tech, the company said.
“Scaffolds play an important role in aesthetic surgery, where we deal with rejuvenating weakened tissue. We have studied soft-tissue support products through the years, but they are much different; they don’t add long-term tissue strength and aren’t as biocompatible. Galatea scaffolds are made of an easily absorbable monofilament, rather than a multifilament, which reduces infection. GalaForm 3D is a novel scaffold with out-of-the-box shape to better fit the patient’s natural curves. I’m looking forward to using this game-changing 3D scaffold in my patients that require soft tissue support,” plastic surgeon Dr. William Adams said in a prepared statement.
The device was cleared with indications for soft tissue support and to repair, elevate or reinforce soft tissue due to weaknesses or voids, Galatea Surgical said.