Galatea Surgical, a division of Tepha, a company based in Lexington, Massachusetts, won FDA clearance for its GalaFORM 3D scaffold, a device designed for use during Reconstructive and plastic surgery to support, lift, and reinforce soft tissues. The Scaffold is made of a mo**filament consisting of the naturally occuring poly-4-hydroxybutyrate (P4HB) enzyme. The material slowly disintegrates after implantation, eventually completely disappearing from the body in about 18 to 24 months, and being replaced by the patient’s own tissue. Moreover, it is hoped that being a mo**filament will reduce the chance of infection.
The GalaFORM 3D is indicated for “soft tissue support and to repair, elevate, and reinforce soft tissue where weakness or voids exist,” according to Galatea. It has a tough rim that helps to give strength to the device and therefore supporting the tissues surrounding it.
The product is available in a variety of shapes and sizes to fit different patients and the anatomies being worked on.
05-04-2017, 12:54 AM
GalaFORM 3D Scaffold FDA Cleared for Plastic, Reconstructive Surgeries
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