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 bodyโ€™s shape for easier placement. The device is based on Tephaโ€™s proprietary P4HB bioresorbable polymer tech, the company said.

โ€œScaffolds 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 donโ€™t add long-term tissue strength and arenโ€™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 patientโ€™s natural curves.ย Iโ€™m looking forward to using this game-changing 3D scaffold in my patients that require soft tissue support,โ€ 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.